378/2007 Coll.


LAW
Dated December 6, 2007

On pharmaceuticals and amending some related laws

(Pharmaceuticals Act)

Change: 124/2008 Coll.

Change: 296/2008 Coll.

Change: 141/2009 Coll.

Change: 291/2009 Coll.

Change: 281/2009 Coll.

Change: 75/2011 Coll.

Change: 375/2011 Coll.

Change: 50/2013 Coll.

Change: 70/2013 Coll.

Change: 70/2013 Coll. (Part)

Change: 70/2013 Coll. (Part)

Change: 70/2013 Coll. (Part)

Change: 70/2013 Coll. (Part)

Change: 250/2014 Coll.

Change: 80/2015 Coll.

Parliament has passed this Act of the Czech Republic:
PART ONE



DRUGS TITLE
I
PRELIMINARY PROVISIONS

Part 1

Subject Matter


§ 1

(1) This Act transposes the relevant European Union ^ 1) and
adjusts further to the directly applicable European Union regulations ^ 2)

) Research, manufacture, preparation, distribution, control and elimination
medicines and medicinal substances (hereinafter referred to as "drugs")

B) registration, post-marketing surveillance, prescribing and dispensing of medicinal products
sale of selected medicinal products and provision
information

C) international cooperation in ensuring the protection of public health and
creating a single market for medicines European Union

D) documentation of the activities listed in subparagraphs a) and b).

(2) This Act has been notified in accordance with Directive
European Parliament and Council Directive 98/34 / EC of 22 June 1998 laying down a procedure for the provision of information
in the field of technical standards and regulations and rules on information
company, as amended by Directive 98/48 / EC.
Part 2

Basic provisions


§ 2

(1) medicinal product means

A) a substance or combination of substances presented as having curative or preventive properties
disease in humans or animals, or

B) a substance or combination of substances which may be used in or administered
people or used in or administered to animals, either for the purpose
restoring, correcting or modifying physiological functions by exerting a pharmacological
, immunological or metabolic action, or
making a medical diagnosis.

(2) Medicinal products referred to in paragraph 1 shall

A) human medicines intended for human use or administration
people

B) veterinary medicinal products intended for animal use or administration
animals; for veterinary medicinal products are deemed medicated feed
and are not considered these additives, 3)

C) human immunological medicinal products consisting of vaccines, toxins, serums or allergen
products; list of vaccines, toxins, serums and allergen products
in the implementing legislation,

D) immunological veterinary medicinal products administered for
produce active or passive immunity or to diagnose the state
immunity

E) human autogenous vaccine prepared for a specific patient from
pathogens or antigens obtained exclusively from this patient

F) veterinary autogenous vaccines, which means
inactivated immunological veterinary medicinal products manufactured from pathogens or
antigens obtained from an animal or animals in breeding, and which are used to treat
animal or animals in the breeding in the same locality,

G) homeopathic products made from homeopathic
accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia ^ 4)
or, in the absence thereof, the pharmacopoeia used officially Currently
least one Member State of the European Union (hereinafter "
Member State"); homeopathic medicine is considered a medicine, although not entirely
properties of medicines and substances contained in it are not always
agents with proven therapeutic effect,

H) radiopharmaceuticals, which means medicines that, if
ready for use, contains one or more radionuclides (radioactive isotopes
) included for a medicinal purpose

I) radionuclide generators, which means systems containing
fixed parent radionuclide from which is produced a daughter radionuclide which is
elution or by any other method and used as a radiopharmaceutical
or for its preparation, | ||
J) kits, which are products intended to be reconstituted or combined with

Radionuclides in the final radiopharmaceutical, usually prior to its administration
,

K) radionuclide precursors which means radionuclides produced
radiolabelling another substance prior to administration,

L) blood derivatives, which means industrially produced medicinal
products derived from human blood or human plasma;
blood derivatives include, in particular albumin, coagulation factors and immunoglobulins of human origin
,

M) herbal medicines containing as active ingredient at least one
herbal substance or at least one herbal remedy or at least 1
herbal substance in combination with at least one vegetable product,

N) transfusion products, which means human blood and its components
prepared for administration to humans for the treatment or prevention of disease
unless the blood derivatives; for human blood and its components
for the purposes of this Act shall not blood stem cells and lymphocytes
donor hematopoietic stem cells for the beneficiaries of these cells

O) reserved medicinal products which can, by a decision on registration
sold without prescription outside pharmacies,

P) medicinal products for gene therapy ^ 86), which means
biological medicines with the active ingredient, which contains
recombinant nucleic acid or the acid is formed,
used or administered to humans regulating, repairing, replacing, adding or deleting
genetic sequence being therapeutic, preventative or diagnostic
effect of these medicines directly relates to
recombinant nucleic acid sequence or the product of genetic expression of this sequence
; medicines for gene therapy exclude
vaccines against infectious diseases,

Q) medicinal products for somatic cell therapy, which means
biological medicinal products intended for the pharmacological, immunological or metabolic
action of its cells or tissues for
treatment, prevention or diagnosis of disease in humans and that
contain such cells or tissues, or they are formed,

First where as a result of substantial manipulation altering their
physiological functions, biological or structural properties
relevant for the intended clinical use, while an essential
handling is not considered particularly manipulations listed in Annex no. 1
directly applicable EU regulations governing medicines
advanced therapy ^ 87), or

Second not intended for use by the recipient in the same basic function
or the same functions as the donor.

(3) The substance shall mean any matter irrespective of origin which may be


) Human, eg human blood, its components and products derived from human blood
,

B) animal, eg micro-organisms, toxins, whole animals, parts
organs, animal secretions, extracts or blood products;

C) vegetable or

D) chemical.

(4) The agent referred to in paragraph 3 is mainly considered

A) drug substance means any substance or mixture of substances
intended for use in the manufacture or preparation of a medicinal product which is
after use in the manufacture or preparation becomes an active ingredient of a medicinal product intended
to exert a pharmacological, immunological or metabolic action
view to restoring, correcting or modifying physiological functions
or to making a medical diagnosis

B) adjuvant, which means any ingredient of a medicinal product, which is not
drug or packaging material.

(5) Pre-mix for medicated feed (hereinafter referred to as "medicated premix") shall mean
veterinary medicinal product subject to registration, which is
intended solely for the manufacture of medicated feeds.

(6) medicated feed is a mixture
medicated premix or medicated premixes and feed or feeds which is intended for putting
into circulation and to be fed to animals without further processing or modification.

§ 3

(1) SmPC means a written summary of information about
medicine, which is part of a medicinal product
and contains information essential to its proper use.

(2) The withdrawal period for the purposes of this Act
period between the last administration of the medicinal product to animals, in accordance with this Act

Under normal conditions of use of the preparation and the moment
can obtain from these animals animal products intended for human consumption
. This period is established under the protection of public health,
to ensure that such foodstuffs do not contain residues
pharmacologically active substances in excess of the maximum limits set
directly applicable EU regulation laying down procedures for
establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin
^ 5).

(3) Pharmacovigilance shall mean supervision of medicinal products aimed
to ensure security and the most favorable balance of risks and benefits of the medicinal product
. Pharmacovigilance includes especially
gathering information relevant to the safety of the medicine,
including information obtained through clinical trials, their
evaluation and implementation of appropriate measures.

(4) Adverse medicinal product for the purposes of this Act, a
response to a medicinal product which is noxious and unintended
. Adverse effect of the veterinary medicinal product for the purposes of this Act
mean an adverse and unintended response to the
administration which occurs at doses normally used for the prophylaxis, treatment
or diagnosis of disease or to restore, correct or otherwise
modifying physiological functions; where clinical trials
veterinary medicinal product in terms of adverse and unintended
reaction to any administered dose. This definition does not cover
transfusion products. Side effects of medicines are distinguished in particular


A) serious adverse events that have resulted in death, life
require hospitalization or prolongation of existing hospitalization,
result in persistent or significant disability or incapacity, or
is a congenital anomaly or birth defect in offsprings,

B) unexpected adverse events, the nature, severity or
result is contrary to the information given in the summary of product characteristics for
authorized medicinal product or are in conflict with
available information, such as a file information for
investigator with medicinal product that is not registered,

C) adverse effects, in connection with the use of a veterinary medicinal product
occurring in humans are harmful and unintended, and
which occur in humans after exposure to a veterinary medicinal product
.

(5) adverse events for the purposes of this Act
adverse change to the health affecting a patient or trial subject
receiving medicinal product other than the transfusion product, even
it is not known whether a causal relationship to treatment with this medicine.

(6) Serious adverse event for the purposes of this Act
such adverse event that results in death, is life,
requires hospitalization or prolongation of existing hospitalization,
results in persistent or significant injury or restrictions
capability or is a congenital anomaly or birth defect in
offsprings, irrespective of the dose of medicine.

(7) Post-authorization safety studies in veterinary medicine
For the purposes of this Act
pharmacoepidemiological study or a clinical trial carried out in accordance with the authorization and
aim of identifying or quantifying a safety hazard relating
to an authorized medicinal product.

(8) risks associated with the use of a medicinal product for the purposes of this Act means


A) risks related to quality, safety or efficacy of the medicinal product
human health, public health, or animal health, or

B) the risk of adverse effects on the environment.

(9) the risk-benefit assessment means
positive therapeutic effects of the medicinal product in relation to the risks referred to in paragraph 8.
risk-benefit ratio is favorable when
benefit from the use of medicinal product prevails the risks associated with its use
.

(10) haemovigilance means of systematic surveillance procedures

Over transfusion products and raw materials from blood and its components
for further production (hereinafter "the raw material for further production")
relating to serious adverse or unexpected events or reactions in donors or recipients
, and the epidemiological monitoring of donors.

§ 3a

(1) Post-authorization safety studies in human medicine is
for the purposes of this Act, any study regarding
authorized medicinal product conducted in order
identifying, characterizing or quantifying a safety hazard, confirming || | safety profile of the medicinal product, or of measuring the effectiveness
measures of the risk management.

(2) Non-interventional post-marketing studies in human medicine
For the purposes of this Act, any study where the
authorized medicinal product used in the normal manner and in accordance with its terms
registration and where the use of a medicinal product is not intended
inclusion of patients in such studies, but a decision
attending physician, whereas patients with
no additional diagnostic or monitoring procedures for analyzing data collected
apply epidemiological methods; non-interventional post
studies include studies epidemiological, and pharmacoeconomic research
.

(3) Pharmacovigilance system for the purposes of this Act
monitoring and reporting system used by the marketing authorization holder and
authorities executing the state administration in the area of ​​pharmaceuticals to complete tasks and ensure
obligations referred to in Chapter Five this Act concerning
pharmacovigilance and designed to monitor the safety of authorized
medicinal products and detect any change to their risk-benefit
.

(4) basic document pharmacovigilance system for the purposes of this Act
means a detailed description of the pharmacovigilance system
used by the marketing authorization holder for one or more
authorized medicines.

(5) risk management systems for the purposes of this Act
set of pharmacovigilance activities and interventions designed to identify, characterize,
prevent or reduce the risks associated with the medicine, including the assessment of the effectiveness
those activities and interventions.

(6) Risk management plan for the purposes of this Act
detailed description of the risk management system.

(7) Serious adverse reactions for the purposes of this Act
unintended response in donor or in patient associated with the collection of blood or its components
transfusion or blood product transfusion, which has
fatal, life-threatening , persistent or significant disability or incapacity
patient or requires hospitalization or prolongation of existing hospitalization
.

(8) Serious adverse events for the purposes of this Act
untoward occurrence associated with the collection of blood or its components
testing, processing, storage and distribution
released for transfusion product or raw materials for further manufacture or
dispensing transfusion products, which could result in death threats
life, persistent or significant disability or incapacity
patient.

(9) The reference substances for the purposes of this Act, substances with
defined purity, a valid certificate stating
quality and shelf life.

(10) the launch of a medicinal product on the market in the Czech Republic for the purposes of this Act means
its transmission after manufacture, delivery
from another Member State of importation or that are made for the purpose of distribution
medicinal product, excluding its use in clinical
evaluation.

§ 4

(1) Name of the medicinal product shall mean the name, which may be either an invented name
interchangeable with the common name, or a common or scientific name accompanied
name or trade mark holder
decision on registration. A common name means the international non-proprietary name
recommended by the World Health Organisation, or, in the event that such
international non-proprietary name does not exist, commonly used name.

(2) Strength of the medicinal product shall mean the content of the active substances expressed
quantitatively per dosage unit of volume or weight according to

Dosage form.

(3) Immediate packaging is such form of packaging that is in direct contact with
medicine. Outer packaging means
packaging into which the immediate packaging is placed. Labelling means
information provided on the inner or outer packaging.

(4) The leaflet is understood information for the user, which is part
medicine.

(5) A batch for the purposes of this Act means the quantity of a product manufactured or prepared
in one production cycle or procedure or
homogenised during preparation or manufacture. A basic feature of the lot is
homogeneity of product units making up the lot.

(6) Devices transfusion service means
provider of health services, for which it carries out sampling and testing of human blood or its components
when intended for transfusion or processing for any purpose
, and which is carried out further processing of human blood or its components
to obtain transfusion products or raw materials for further
manufacture of medicinal products, including control and release, as well as their
storage and distribution. For transfusion service is not
blood bank.

(7) Blood bank shall mean an organizational unit
providers of health services, which are stored and issued transfusion
products exclusively for use by healthcare providers, or
which is carried out pre-transfusion
immuno examination. The procedure for dispensing transfusion products down detailed
legislation.

§ 5

(1) Handling of drugs for the purposes of this Act means their
research, training, treatment, control, manufacture, distribution, storage and
storage, supply and transportation, offering for sale, distribution, | || sales of possession for the purpose of business, provision of promotional samples
use of medicinal products in the provision of health services or health care
or removing drugs.

(2) drug research for the purposes of this Act
nonclinical evaluation of drug safety and clinical trials on medicinal products with
order to prove their efficacy, safety or quality.

(3) Preparation of medicinal products shall mean the making of pharmacy
or other workplaces where medicinal products may be prepared according
§ 79 paragraph. 2nd

(4) the regulation of medicinal products shall mean such procedure which is carried out by


) Medicinal products subject to authorization before dispensing or using
in the provision of health services or health care
in accordance with the summary of product characteristics and according to the manufacturer in case
procedure under § 8. 3 to 5 or conditions set
specific therapeutic program

B) IMPs before using them in the context of
clinical trial, in accordance with the protocol and approved procedures
clinical trial;

Procedures referred to in subparagraphs a) or b) which are unreasonably demanding or dangerous
despite otherwise meet the characteristics of regulation by these letters are deemed
training; the list of such procedures shall be laid down
regulation.

(5) Distribution of drugs shall mean all activities consisting of
procurement, storage, delivery, including the delivery of drugs within
European Union and exports to countries other than the Member States (hereinafter
"third country '), and relevant business transfers irrespective
fact whether an activity undertaken in return for payment or free of charge.
Distribution of medicinal products is carried out in cooperation with producers,
other distributors or pharmacies and other persons authorized
supply medicinal products to the public or medicines
use. Distribution of medicinal products is not
dispensing of medicinal products, their sale vendor of selected medicinal products and
their use in the provision of health services and health care, as well as
distribution of transfusion products transfusion service and distribution of raw materials
for further production facilities transfusion service.
For the distribution of medicines are also not considered
imports of medicinal products from third countries.

(6) Dispensing medicines means to provide for conditions

Mentioned in § 82 para. 2. The dispensing of medicines is regarded as their
mail order providing for the conditions specified in § 84 to 87. For
transfusion products with dispensing means providing transfusion
providers of health services, equipment
transfusion service or blood bank for transfusion to a particular recipient.
This provision shall not prejudice the rules governing VAT
values ​​and Consumer Protection ^ 6).

(7) The sale means the sale, purchase or storage of reserved
medicines.

(8) Use of medicinal products

A) in the provision of health services means

First their administration to a patient in providing these services, or

Second Equipment patient according to § 8. 1
necessary quantity of medicinal products at hospital discharge or transfer the patient to another provider
health services, or

Third Equipment patient according to § 8. 1 the required quantity of medicinal products
provider of health services in general practice
medicine in the field of general practitioner for children and adolescents and
provider of emergency medical services.

B) the provision of veterinary care means to provide
breeders for subsequent submission to the animals or their direct
administering to animals, under the conditions laid down in this Act and legislation
^ 8).

(9) Circulation of drugs for the purposes of this Act means the supply of medicines
persons referred to in § 77 par. 1 point. c) paragraphs 2-7 and 10
dispensing of medicines, including the dispensing of transfusion products, distribution
blood products, sale of selected pharmaceuticals and
use of medicinal products in the provision of health services or health care
.

(10) Putting medicated feed into circulation means holding
medicated feed for sale or any other manner
provision to other persons or private sale or provision
medicated feed to others, regardless of whether
regards the activities carried out in return for payment or free of charge.

(11) Abuse of medicinal products for the purposes of this Act
intentional excessive use of medicinal products or intentional use
medicines in a manner that is contrary to the intended purpose
use, possibly after their further processing accompanied
harmful effects on the organism, including the adverse effects on the psyche
.

(12) Using a veterinary medicinal product outside the scope of
registration means the use of a veterinary medicinal product that
not consistent with the summary of product characteristics. For control purposes
use, prescription and dispensing of medicinal products in
veterinary care and pharmacovigilance using
veterinary medicinal product outside the scope of the registration means further
well as improper use or abuse of the product.

(13) Brokering of medicinal products for the purposes of this Act
means all activities related to the purchase or sale
medicinal products that do not include physical handling
products or their distribution, and whose essence is independent
negotiations for the purchase or sale of medicinal products on behalf of another person.

(14) Falsified medicinal product for the purposes of this Act
any human medicine

A) which are given false information about his identity, including
packaging and labeling, its name or its composition as regards any of his
ingredients including excipients and the strength of those ingredients,

B) which are given false information about its origin, including the producer
country of manufacture, country of origin or the marketing authorization holder, or

C) which is accompanied by documentation containing false information about his
history, including the records and documents relating to the
distribution channels.

(15) Medicinal products with unintentional quality defects for
falsified medicinal product referred to in paragraph 14 does not.

§ 6

(1) The purpose of this Act is

A) a manufacturer of medicinal products, a person importing medicinal products from third countries
, transfusion services, operator control
laboratories and manufacturers of active pharmaceutical ingredients,


B) a pharmaceutical distributor (the "Distributor")

C) a person authorized to provide health services under the Act on Health Services
^ 9) (hereinafter "the medical service")

D) a person authorized to provide veterinary care according to legal regulations
^ 10)

E) a person organizing or conducting research of pharmaceuticals, or

F) vendor of selected medicinal products.

(2) Good Manufacturing Practices for the purposes of this Act
set of rules that ensure that the manufacture and control of medicines
are conducted in accordance with the requirements for their quality, intended use and appropriate
documentation.

(3) Good distribution practice for the purposes of this Act
set of rules that ensure that the distribution of drugs or
auxiliary substances, carried out in accordance with the requirements for their quality, are intended
using as appropriate documentation.

(4) good laboratory practice for the purposes of this Act, a system of quality assurance
concerned with the organizational process and the conditions under which non-clinical
drug safety studies are planned, performed,
monitored, recorded, submitted and archived.

(5) good pharmacy practice for the purposes of this Act
set of rules that ensure that the preparation, processing, inspection,
storage and dispensing of medicines are conducted in accordance with the requirements of their
quality, safety, efficiency and awareness
patients, and in accordance with the intended use of medicines as
relevant documentation.

(6) Administrative practice of vendors of selected medicinal products for the purposes of this Act
mean a set of rules that ensure that the sale
selected medicinal products were made in accordance with the requirements
quality, safety and efficacy selected medicinal products, in
accordance with their intended use.

§ 7

(1) persons dealing with drugs are required

A) ensure the maximum benefits of medicines for their use and reduce to the lowest possible level
adverse consequences of drug action on health
human and public health, animal health and the environment

B) follow the instructions for handling a medicinal product by
summary of product characteristics, unless the use of medicines in accordance with § 8 paragraph
. 3-5 or pursuant to § 9. 2 or 5 for use
veterinary medicinal products.

(2) Activities involving the handling of pharmaceuticals may be carried out only by persons authorized
to the activity under this Act.
Part 3


Use of medicinal products in the provision of health services and health care


§ 8

Use of medicinal products in the provision of health services

(1) Prescribe, put into circulation or used in the provision of health services
can only registered human medicinal products
according to § 25, unless stated otherwise.
Provide patients with medicinal products in the provision of health services under § 5 para. 8 point. a)
possible only if the patient's condition necessitates immediate
use of the medicine and due to local or temporal
unavailability of pharmaceutical care is not possible timely dispensing of medicinal
prescription medicine; way outfitting the patient
medicinal products in the provision of health services in an implementing regulation
.

(2) Prescribe and use in the provision of health services should be
medicinal products prepared in a pharmacy and other workplaces
where you can prepare medicinal products in accordance with § 79 para. 2, and transfusion preparations
manufactured in blood centers.

(3) The provision of medical services to individual patients may
physician to provide optimal health services
prescribe or use medicinal products not registered under this Act
, only in situations where the same time

A) it is not distributed or circulated in the Czech Republic medicinal product
corresponding composition or similar therapeutic properties
who is registered

B) it is a medicinal product which is

First already registered in another state or

Second advanced therapy product whose manufacturer is a licensee

For the manufacture of the dosage form to the extent corresponding permit to manufacture
IMPs issued by the State Institute for Drug Control
,

C) such a method is sufficiently justified by scientific knowledge and

D) is not a medicinal product containing a genetically modified organism
^ 11).

(4) The physician may, if the medicinal product is not distributed
or not in circulation medicine
required therapeutic properties, use an authorized medicinal product in a manner not in accordance with
SPC, however, if such a method
sufficiently justified by scientific evidence.

(5) The provider of health care services is responsible under the legislation ^ 9)
for personal injury or death of a man that occurred as a result
use of an unauthorized medicinal product or a use of the registered
medicinal product in the manner specified in paragraph 4 when wishing
attending physician prescribe or use unregistered medicinal product or use
authorized medicinal product in the manner specified in paragraph 4, familiar with
this fact and consequences of treating a patient or his legal
representative. However, where the health status of the patient such acquaintance, so make
doctor after using the medicine immediately once
patient's health condition allows. In the case of unregistered
prescription medicine, doctor this fact in the
prescriptions. Prescribing or use of an unauthorized medicinal product
doctor immediately notify the State Institute for Drug Control
. The method and scope of the notification of the prescription or use of unauthorized medicinal product
State Institute for Drug Control
in the implementing legislation. If it is a radiopharmaceutical, the State Institute for Drug Control
inform him the use of an unregistered notified
radiopharmaceutical State Office for Nuclear Safety.
Medicinal product pursuant to paragraph 3. b) paragraph 2 shall be marked at least
manner specified in § 57 par. 2nd

(6) When the suspected or confirmed spread of zoonotic diseases
toxins, chemical agents or suspected or confirmed
radiation accident or disaster that could seriously threaten public health
, the Ministry of Health exceptionally
temporary decision issued after seeking expert opinion of the State Institute for Drug control
authorize the distribution, dispensing and use of unregistered human
the medicinal use of the registered
human medicinal product in a manner which is not in accordance with the decision on registration .
In this case, the marketing authorization holders, manufacturers of medicinal products
and health workers are not responsible for the consequences
resulting from such use of the medicinal product. This is true regardless
whether or not granted an authorization pursuant to § 25 paragraph.
First responsibility for defects of medicinal products under a special legal regulation
^ 12) is not affected. The measures issued by the Ministry of Health informs
State Institute for Drug Control.
The Ministry of Health issued measures be posted on its official board and the State Institute for Drug Control
publish a manner enabling remote access, or even
in the Bulletin of the State Institute for Drug Control.

(7) The provisions of this Act shall not affect the legal provisions
regulation governing radiation protection of persons undergoing medical examination or treatment
or rules laying down basic safety standards
to protect public health and workers against the dangers
ionizing radiation ^ 13).

(8) Treat medicines otherwise than in accordance with this Act
is prohibited.

§ 9

Use of medicinal products in veterinary care

(1) In the provision of veterinary care may be prescribed, issued
or used, unless this Act otherwise provided below, only

A) veterinary medicinal products registered in accordance with § 25, including
authorized medicated premixes in the form of medicated feeds
manufactured and marketed in accordance with this Act,

B) veterinary autogenous vaccines that meet the requirements of this
Act


C) medicinal products prepared in a pharmacy for an individual animal in accordance with Regulation
veterinarian

D) medicinal products prepared in accordance with the articles of the Czech Pharmacopoeia and
manner stipulated by the implementing legislation in the pharmacy or in the workplace
other healthcare providers authorized by §
79 par. 2 to prepare medicines | ||
E) veterinary medicinal products registered in another Member State in accordance with regulation
EU-14) and under the conditions laid down
according to § 48

F) human medicinal products authorized under § 25th

(2) The provision of health care may also be prescribed,
published or used within the limits imposed by the competent authority under §
46 or 47

) Medicinal products for which the Central Veterinary Administration has issued
State Veterinary Administration (hereinafter "the Central Veterinary Authority")
exception or

B) unauthorized immunological veterinary medicinal products authorized for
conditions specified in § 47, the use of which the European Commission decided
(hereinafter "Commission") in accordance with European Union regulations concerning some serious
animal diseases ^ 15).

(3) Medicinal products referred to in paragraph 1 and paragraph 2 letters. a) may be
in veterinary care prescribed, issued or used
only in accordance with the procedure laid down by the implementing legislation.
Implementing regulation lays down such a procedure separately for animals
that produce animal products intended for human consumption, including
animals belonging to the family Equidae, which are in accordance with relevant regulations
EU-16 ) declared that they are not intended to
slaughtered for human nutrition, and especially for animals that
produce animal products intended for human consumption.
Further implementing regulation lays down the procedure for use, dispensing or prescribing
other than authorized veterinary medicinal products, including
veterinary medicinal products to be used in animals outside
Holder.

(4) The veterinary medicinal product for which the Institute for State Control
veterinary biologicals and pharmaceuticals decision under § 40 par. 4
restricted circle of persons who are authorized to use
veterinary medicinal products may be used only by a veterinarian.

(5) Medicinal products pursuant to paragraph 1. b) to f) and paragraph 2 and
registered veterinary medicines used outside the scope
authorization can only be administered by a veterinarian who is authorized to determine the
drug administration breeder or authorized person
. Veterinarian responsibility for damage caused by using
medicinal product by the first sentence is not identifying such persons affected.

(6) Medicinal products containing thyreostatic substances, hormone substances
or beta-agonists may be for the purpose of providing veterinary care
prescribed or used only if the conditions are met
laid down in special legislation ^ 17).

(7) Immunological veterinary medicinal products may only be for the purpose
veterinary care prescribed or used only in the event that their
use does not conflict with control or safeguard measures
veterinary authorities laid down by special legal
prescription ^ 18).

(8) For animals which produce animal products intended for human consumption
shall apply restrictions on the maximum residue limits set
directly applicable EU regulation ^ 5).

(9) Animal breeders producing animal products intended for human consumption must
after drug administration observed
withdrawal period specified in the marketing authorization or determined in accordance with paragraph 10.
Veterinarians who use, publish
or prescribe medicinal products are required to inform breeders of animals producing
animal products intended for human consumption by the trade deadline that must be met
.

(10) If the marketing authorization for the medicinal product does not
species or category of animals withdrawal period must be protective
period determined in accordance with special legislation 18). When

Drug administration animal belonging to the equidae family
which is in line with the relevant EU regulation ^ 16)
declared that it was not intended for slaughter for human nutrition, if such product contains
substance defined by the Commission as necessary for the treatment of equine
must be a withdrawal period of 6 months.
In the case of homeopathic veterinary medicinal products containing
substances included in Annex II of the directly applicable European Union
^ 5), the withdrawal period does not.

(11) O prescribing, dispensing or use of medicinal products in veterinary care
lead people who medicines
prescribe, dispense or use records. Records shall be kept
at least 5 years. Implementing legislation and stipulates how
content of such records.

(12) The provision of veterinary care can prescribe, issue or use
medicines, in the case of activities carried out in order
business, a veterinarian who meets the requirements for the performance of professional veterinary activities
by special legislation 19).
In the case of medicinal products, prescription prescription,
medicine may be prescribed, dispensed or used only in such
amount which is necessary for appropriate treatment or therapy. When
compliance with the conditions laid down in this Act and legislation ^ 8) may
breeders ^ 20) administer medicinal products to animals which own or
which they are entrusted.

(13) Persons who are resident or established ^ 21) in another Member State
than in the Czech Republic and which are in accordance with the special legal regulation
^ 19) authorized to provide health care in the Czech
Republic are entitled to use medicines to the extent specified
implementing regulation. Implementing legislation this
range determined with regard to the registration status of medicines that
to be used, method of transportation, packaging and condition requirements for the composition
these medicines. The use of medicines
keep records in accordance with paragraph 11. To this end, these persons are authorized to import
in the Czech Republic medicinal products in quantities that exceed
day consumption for the scope provided veterinary care.

(14) for the use of authorized veterinary medicinal products
unless the immunological veterinary medicinal products administered in the form
feed in the economy ^ 20) can only use such technology
device that is part of the economy and that set
relevant regional veterinary administration of the State veterinary administration or
Municipal veterinary administration in Prague State veterinary administration (hereinafter
"regional veterinary administration") animal health conditions and measures in accordance
a special legal regulation 18); if no such measures
relevant technological device is determined, the farmer
such equipment for the purpose of medication used to determine health conditions and measures
respective regional veterinary administration, which
about fixing these terms and measures requests.

(15) Breeders who as entrepreneurs keep animals from which they are derived
animal products intended for human consumption, and who are in possession
medicines intended for treatment of animals, they are obliged to keep after
at least 5 years evidence about how such medicines
acquired. This is true even if the animals for which such medicinal products are intended
been slaughtered or are no longer in the possession
breeder.
TITLE II

ASSURANCE OF DRUGS

Part 1


Tasks of state administration bodies in the field of pharmaceuticals

§ 10

State administration

(1) State administration in human medicines carry

A) Ministry of Health,

B) The Ministry of the Interior,

C) The Ministry of Justice

D) Ministry of Defence,

E) The State Institute for Drug Control

F) Ministry of the Environment

G) the customs authorities

H) The State Office for Nuclear Safety,

I) regional offices.

(2) State administration in the field of veterinary medicines carry

A) The Ministry of Agriculture


B) The Central Veterinary Administration

C) The Institute for State Control of Veterinary Biologicals and pharmaceuticals

D) regional health authorities,

E) The Ministry of Environment

F) customs authorities

G) The State Office for Nuclear Safety,

H) regional authorities.

§ 11
The Ministry of Health


The Ministry of Health in human medicines

A) decide whether to consent to the implementation of specific treatment programs and
over these programs, exercises control,

B) authorizes use for human use, the active ingredient and excipients
not included in the list established by the implementing legislation,

C) participates in the preparation of a European Pharmacopoeia ^ 4) and is responsible for ensuring its
preparation and publication of the Czech Republic, even for
area of ​​veterinary medicines,

D) gives the Czech Pharmacopoeia, which sets out the procedures and requirements for

First production of medicinal substances and excipients,

Second production and preparation of medicines

Third testing and storage of drug substances, excipients and medicinal
products

E) decide in the first instance administrative infractions that occur during
distribution, import or export of transfusion products and raw materials for further manufacture
,

F) published in the Bulletin of the Ministry of Health and in a manner allowing remote access


First List of persons authorized to remove medicines,

Second List of people organizing courses for sellers of reserved medicinal products
authorized under special legal regulations 22)

G) decide on the designation of an ethics committee issuing opinions on
multicentre clinical trials and may establish an ethics commission
in accordance with § 53 par. 1 issuing an opinion on the clinical trial
medicinal product

H) take measures to ensure the availability of medicines
important for the provision of medical services and taking measures to
support research, development and availability of medicines for rare diseases and
medicines, which can be as such determinations,
as well as medicines for use in pediatric medicine,

I) ensures the necessary measures to promote self-sufficiency
European Union and the Czech Republic in the area of ​​human blood or human plasma and accepts
measures for preventing risks to public health
connection with the use of human blood or human plasma

J) To promote the voluntary unpaid donation of human blood and its components
takes measures necessary for the development of production and use
products derived from human blood and its components from voluntary unpaid donors
; these measures notified to the Commission, starting eighth
February 2008 and subsequently once every three years,

K) report to the Commission on the activities undertaken in connection with
provisions concerning standards of quality and safety for the collection
testing, processing, storage and distribution of human blood, its
components, transfusion products and raw materials for further production, and it
beginning December 31, 2007, then December 31, 2009 and then every
once every three years, including measures taken in the field
inspections and monitoring

L) issue an opinion on the need for a medicinal product with a view to protecting public health
for receipt of registration
from another Member State

M) approve the appointment of representatives of the State Institute for Drug Control
committees pursuant to directly applicable EU-23) and
Management Board of the European Medicines Agency ^ 24) (hereinafter "the Agency") | ||
N) inform the State Institute for Drug Control Abuse
medicinal products, which are in the exercise of its jurisdiction learns

O) issuing a temporary measure pursuant to § 8. 6, which authorizes
distribution, dispensing and use of an unauthorized medicinal product or
use of an authorized medicinal product in a manner not in accordance with
registration decision,

P) decide, in the case of transfusion products or raw materials for further
manufacture of consent with their distribution
out between the Czech Republic and another Member State and their exports to third countries and imports
from a third country; Information about the decisions taken
public.

§ 12

Ministry of Interior, Ministry of Justice and Ministry of Defence


Tasks of government established by this Act in the area of ​​control pursuant to §
101 and the imposition of sanctions under § 103-109 perform
provider of health services in the Ministry of Interior, Ministry of Justice and Ministry
defense under their jurisdiction
this ministry.

§ 13

State Institute for Drug Control

(1) The State Institute for Drug Control, based in Prague (hereinafter
"Institute") is the administrative authority nationwide
subordinate to the Ministry of Health. The Institute is headed by the Director; his selection, appointment and dismissal
are governed by the Civil Service Act.

(2) Institute in human medicines

) Issue

First Holder medicines, its variations,
renewal, transfer, suspension and withdrawal of the decision on the takeover
registration decision for parallel import authorization, the decision to prevent
medicinal product

Second manufacturing authorization for medicinal products, the manufacturing authorization
transfusion products and raw materials for further production license for the control
laboratories and permission to distribute medicines, decides
modification, suspension and revocation of permits issued, || |
Third Certificates operators, which certifies that the conditions
good manufacturing practice, good distribution practice, good clinical
practice, good laboratory practice and good practice of vendors of selected
medicines

Fourth Certificates operators conducting nonclinical studies
drug safety, which certifies that the conditions
good laboratory practice

Fifth opinion on the drug, which is an integral part of the medical device
, at the request of an authorized person under special legal regulations
^ 26)

6th Opinion on the proposal for a specific therapeutic program to the extent specified in §
49

7th opinion on the use of the active substance or excipients for human use
not included in the list established by the implementing legislation,

8th binding opinion on the substantive and technical equipment
medical devices, which will be provided pharmacy services under the Act on Health Services
^ 9)

9th approval according to § 77 par. 1 point. i) the implementation of import from a third country
medicinal product which is not authorized in any Member State
even within the European Union,

10th expert opinion at the request of the Ministry of Health,
to permit the distribution, supply and use of unregistered human
the medicinal use of the registered
human medicinal product in a manner that is not consistent with the authorization under conditions
specified in § 8. 6

B) authorize clinical trials on medicinal products, comments on the reported
clinical trial and decide on the termination or suspension
clinical trial in the case of multi-center clinical trials conducted
parallel in several Member States and the Czech
Republic formulates a unified position for the Czech Republic,

C) in the case of threat to life or health, especially if
findings of serious adverse drug reactions or suspected
of its serious adverse events or in the event of fault detection
or suspected quality defects drugs publishes

First temporary measure to suspend the use of drugs or excipients
designed for the preparation of medicines or suspend marketing of the drug or
such excipients into circulation, or

Second Temporary measures of restriction on the placing of individual batches of the drug into
circulation

D) in the case of threat to life or health, especially if
findings of serious adverse reactions or serious adverse events or
suspicion of serious adverse reactions or serious adverse events
issued interim measures to suspend or restrict
use of blood product transfusion; serious adverse reactions and serious adverse events served
Department annual report to the Commission, and always to
30th June the following year,

E) shall, in the case of threat to life or health, especially in cases
findings referred to in subparagraph c) and d) of

First withdrawal of the drug from circulation, including determining the extent of withdrawal, even in

If the medicinal product is marketed as a different product, or

Second removing drugs

F) conducts random drug control laboratory and issues certificates
quality drugs and excipients,

G) checks on operators other persons handling drugs
marketing authorization holders, persons performing brokerage
human medicinal products (hereinafter "Provider"), manufacturers and importers of excipients
compliance with this Act.

H) decide in cases of doubt whether a product or a
active substance or a medicinal product subject to marketing authorization or another
product or a homeopathic medicine, at the request
or on its own initiative,

I) In the first instance in human medicines
administrative offenses and take action for breach of obligations under this Act,

J) the authority responsible for carrying out the tasks of the Czech Republic in the field of pharmacovigilance
providing pharmacovigilance information to the Commission and
Agency

A) evaluate the level of risk for public health protection in the event of
adverse effect or quality defect of a medicinal product, medicinal
or excipients; Was this review
disclose in a manner allowing remote access,

L) allows an exception allowing the use of an unauthorized medicinal product
advanced therapy in a medical facility providing inpatient care
(hereinafter referred to as "hospital exemption") and decide on the termination of the permit
hospital exceptions

M) maintain a register of medicines with limitations.

(3) Institute in human medicines has further

A) monitors

First adverse drug reactions, including the drafting and eventual
organization of non-interventional post-marketing studies and monitoring
drug safety and use of medicines

Second serious adverse reactions and serious adverse events, including
evaluation and implementation of appropriate measures

B) populate and maintain the pool of expert information on pharmaceuticals, including data
related to the consumption of medicines,

C) in a manner allowing remote access, or even in
Bulletin of the State Institute for Drug Control, which means information
Institute (hereinafter referred to as "information agent")
information referred to in § 99 and additional information under this Act,

D) participates in the preparation of a European Pharmacopoeia ^ 4) and participates in the preparation of the Czech Pharmacopoeia
,

E) issue for the customs authority by directly applicable regulations of the European Union
^ 27) binding opinion on the potential measures, including preventive
if it receives the communication on suspension of the release of goods for free
circulation because of the suspicion that the goods are not safe or not
marked in accordance with the laws or international treaties
which the Czech Republic is bound

F) ensuring cooperation in the field of quality, efficacy and safety of drugs
with the competent authorities of the Member States, the Commission and the Agency, including
representation in working groups and committees of these bodies, if
of committees by directly applicable EU-23) and the Management Board of the Agency
^ 24) appoint representatives to approval by the Ministry of health
; at the request of the competent authorities of the Member States, the Commission and the Agency
Department performs other tasks; Department
forward to the Agency a list of experts with proven experience in the evaluation of medicinal products who
are available to serve on working groups or expert groups
Committee ^ 23) together with an indication of their qualifications and specific areas
expertise; This list is updated

G) provides, as reported by the Ministry of Health according to § 11
point. n) pharmacovigilance and within its competence to adopt the appropriate measures
,

H) provides translation internationally recognized medical terminology for pharmacovigilance
into the Czech language and publish in its information resource
guidance on the collection, verification and reporting of adverse effects
, including technical requirements for electronic exchange
pharmacovigilance information in accordance with internationally agreed formats and guidelines
Commission and agencies

I) leads


Register of non-interventional post-marketing studies of medicines
carried out in the Czech Republic

J) collects data on the use of medicines,

K) provides informational links with the European Union and the exchange of information
required by European Union rules,

L) establish and maintain a quality system to ensure the maintenance of records of
qualifications and training of staff of the Institute who carry
evaluation, control and decisions under this Act, including a description
their duties, responsibilities and requirements training

M) keep records

First authorized medicinal products and changes annually announces
Commission and other Member States

Second Operators who have been granted a certificate

Third checks made by these operators

Fourth ethics committees in the Czech Republic

N) establishes and operates a central data repository for the collection and processing of electronically
prescription medicines (hereinafter "
central repository of electronic prescriptions")

O) maintains a register of intermediaries, which is an information system
public administration

P) conduct or promote public awareness campaigns aimed
among others on the dangers of counterfeit medicines and
risks related to medicinal products supplied illegally mail-order dispensing with
electronic means (hereinafter referred to as "mail-order dispensing with
electronic means "), especially in collaboration with
Commission, the Agency and the competent authorities of the Member States.

§ 14
The Ministry of Agriculture


Ministry of Agriculture in the field of veterinary medicines

A) checks the implementation of international treaties in the field of pharmaceuticals,

B) cooperate with the Ministry of Health in the preparation of the Czech Pharmacopoeia
,

C) published in the Bulletin of the Ministry of Agriculture and in a manner allowing remote access


First Information according to § 11 point. f)

Second exemption from registration of medicinal products in veterinary care
stating the conditions laid down for the marketing and use
medicinal product

D) adopt measures to promote research, development and availability of medicinal products
for the purpose of providing health care, with particular regard to
availability of medicines for rare, rare animal species and
occurring therapeutic indications,

E) approve the appointment of representatives of the Institute for State Control of Veterinary Biologicals and
drugs according to § 11 point. m).

§ 15

The Central Veterinary Administration

The Central Veterinary Administration

A) decide on appeals against decisions of the Institute for State Control of Veterinary Biologicals and
drugs and against the decisions of the regional veterinary administration
according to § 17 letter. c)

B) authorizes, with a view to alleviating the suffering of animals or animal health
situation, use unregistered medicines unless adequate
medicinal product is authorized; the permit sets conditions for putting into circulation and use
,

C) issued a decision in which the conditions for the marketing and
use of immunological veterinary medicinal products, whose use
Commission decided

D) authorizes use for veterinary use of the drug substance and excipients
not included in the list established by the implementing legislation.

§ 16

Institute for State Control of Veterinary Biologicals and Medicines

(1) The Institute for State Control of Veterinary Biologicals and pharmaceuticals
is based in Brno (hereinafter the "Veterinary Institute") is the administrative authority with
nationwide, subordinate to the Central Veterinary Administration. The head
Veterinary Institute Director; his selection, appointment and dismissal of the
governed by the Civil Service Act.

(2) Veterinary Institute in the field of veterinary drugs

) Issue

First Holder medicines, its variations,
renewal, transfer, suspension and withdrawal of the authorization decision
parallel import decision on the seizure of a medicinal product; in the case of
Holder immunological veterinary medicinal products
issue such a decision with regard to actions in the field
protection against animal diseases and their control
determined in accordance with special legislation 18) | ||

Second manufacturing authorization for medicinal products, including medicated feed and veterinary
autogenous vaccines authorization to operate a control
laboratories and distribution authorization, decides on the modification, suspension or revocation of a license
issued under this Act

Third Certificates according to § 13 para. 2 point. a) Section 3 of similarly

Fourth opinion on the use of an unauthorized medicinal product in
providing veterinary care and use of the active substance or excipients
substances for veterinary use not on a list established by the implementing legislation
,

Fifth decision on the import of medicinal products authorized in another Member State
,

B) authorize clinical trials of medicinal products and decide on
termination or suspension of the clinical trial

C) in the case of a threat to health or animal life or health of persons or
threats to the environment, particularly in the event of an undesirable effect
medicine or suspicions of its adverse effect
or in the event of faults or suspicion of a quality defect
drug issues temporary measures according to § 13 para. 2 point. c) similarly

D) decide, in case of a threat to health or animal life or health
persons or to the environment of the measures according to § 13 para. 2
point. e) similarly

E) checks in the field of veterinary drugs according to § 13 para. 2
point. f) and g) similarly

F) decide in cases of doubt, pursuant to § 13 para. 2 point. h)
similarly

G) In the first instance in the field of veterinary pharmaceuticals
administrative offenses, if not discuss the regional veterinary administration under § 17
point. c), and take action for breach of duties under this Act
.

(3) Veterinary Institute in the field of veterinary drugs also

A) monitors risk-benefit ratio of medicines
including monitoring of adverse events, including lack
efficacy, off-label use for registration
risks arising from medicinal products for the environment and sufficiency || | withdrawal periods of medicinal products

B) populate and maintain the pool of expert information on pharmaceuticals, including data on consumption
medicines

C) in a manner allowing remote access, or even
in the Bulletin of the Institute for State Control of Veterinary Biologicals and pharmaceuticals
which are informative Veterinary Institute (hereinafter
"information resource Veterinary Institute"), information referred to in § 99
and other information under this Act,

D) participates in the preparation of a European Pharmacopoeia ^ 4) and participates in the preparation of the Czech Pharmacopoeia
,

E) issue a binding opinion pursuant to § 13 para. 3 point. e) similarly

F) ensures cooperation under § 13 par. 3 point. f) likewise;
representative shall, after approval by the Ministry of Agriculture,

G) carries out testing of samples of animal products and feed within
monitoring illicit substances and products or residues of substances with
pharmacological effect or their metabolites ^ 17)

H) carried out by individuals or legal entities
control over prescribing, dispensing and use of medicines, including
medicated feed and veterinary autogenous vaccines; through
regulations for medicated feeds monitors the amount of drugs administered in the form
medicated feeds, gathers and evaluates information on adverse
reactions or quality defects of veterinary autogenous vaccines

I) provides information networking and exchange of information pursuant to § 13 para. 3
point. k) similarly

J) implement and maintain a quality system in accordance with § 13 para. 3 point. l) similarly

K) keep records in accordance with § 13 para. 3 point. m) points 1-3 analogy

L) conducts compliance control under the Law on agriculture-25a)
in accordance with applicable regulations of the European Union governing
detailed rules of cross compliance and the integrated administration and control
system-25b).

§ 17
Regional Veterinary Administration


Regional Veterinary Administration in the field of veterinary medicines

A) carry

First Supervision ^ 28) over the use of drugs in the form of mass medication using
feed under § 9. 14 and performs control over prescribing,

Dispensing and use of medicinal products in veterinary
care

Second through regulations for medicated feeds supervision
putting into circulation and use of medicated feed; in this area cooperate with
Veterinary Institute,

B) through information pursuant to § 71 para. 6 check whether
prescription, production or use of veterinary autogenous vaccines
complies with the requirements laid down by special legislation 18)

C) discussion in the first instance administrative infractions found during
supervision pursuant to subparagraph a) if it does not discuss pursuant to § 16 para. 2 point.
G) The Veterinary Institute, and actions are in breach of the obligations stipulated by this Act
.

§ 18

The State Office for Nuclear Safety

The State Office for Nuclear Safety issued an opinion on registration and
clinical trials of radiopharmaceuticals.

§ 19

Ministry of Environment

Ministry of Environment issued under the conditions specified in § 31 paragraph
. 6 opinion on medicinal products containing genetically modified organisms
^ 11) and comments on the impact of drugs on the environment
environment.
Part 2


Eligibility of persons for handling pharmaceuticals

§ 20
General assumptions


(1) Treat drugs under § 5 para. 1 Only persons over 18 years
, legal capacity, integrity, health and professionally
eligible for a particular kind of activity.

(2) The condition of completion of 18 years pursuant to paragraph 1 shall not apply to persons
drugs that treat the teaching or training under professional supervision
^ 29).

(3) shall be deemed to be unimpeachable natural person who meets the conditions of integrity
under a special legal regulation 29). In the event that
individual resided in the last 3 years continuously for more than 6 months
abroad, also demonstrates the integrity of documents proving
meet the conditions of integrity issued by the states in which the natural person
stayed. In recognition of the integrity of the document issued by the competent
authority of another Member State pursuant to a special legal regulation
^ 30).

(4) The Institute or the Veterinary Institute to demonstrate the integrity
under paragraph 3 requests by special legislation 30a)
extract from the criminal records. The request for an extract from the Register
records and the extract from the criminal records shall be transmitted in electronic form
manner allowing remote access. Compliance with the condition
integrity is further demonstrated by submitting a document
corresponding extract from the Criminal Records issued by the state of which the natural person is a citizen
, as well as the corresponding documents issued by the states on whose territory
a natural person in the last
3 years resided continuously for more than six months. Extract from the criminal records and documents evidencing
integrity of individuals must not be older than 3 months
.

(5) If the other provisions of this Act provides otherwise,
legislation on the competence of healthcare workers and other professionals
^ 29) and the competence to provide veterinary care
^ 19) shall not be affected.

Professional qualification

§ 21

(1) The professional prerequisite for the clinical evaluation of medicinal products
examiner's graduation from an accredited medical
master's study program in general medicine.

(2) The professional prerequisite for clinical trials of veterinary medicinal products
examiner's graduation from an accredited
master's study program in veterinary medicine.

(3) Professional prerequisites for the use of medicinal products in
provision of health services and health care down specific
legislation ^ 19) ^ 29).

§ 22

(1) control activities in the field of pharmaceuticals within the Institute and the Veterinary Institute
is a professional prerequisite for managerial employees
graduation from an accredited healthcare masters study program in pharmacy
^ 31) or an accredited healthcare masters study | || program in general medicine ^ 31)
or an accredited master's study program in veterinary medicine ^ 32) or
accredited master's degree program in veterinary hygiene and

Ecology or an accredited master's degree program in chemistry or biology
, and 5 years of professional experience in the professional activity.

(2) For employees of the Institute and the Veterinary Institute who perform
control activities (hereinafter "inspectors"), in the case of checks
manufacturers, operators conducting nonclinical safety studies
drugs, persons involved the clinical trial, holders
decision on registration, health service providers and veterinarians
professional prerequisite for graduation from an accredited healthcare master's study program
pharmacy ^ 31) or
accredited healthcare masters study program in general medicine ^ 31)
or an accredited master's study program veterinary Medicine
^ 32) or an accredited master's degree program
veterinary hygiene and ecology or an accredited bachelor's degree program
chemistry or biology, and 3 years of professional practice in such
activity that is related to the area in which the inspector conducts inspections
activity; for other controls is a professional prerequisite
least complete secondary education ^ 33), and one year of professional practice in such
activity that is related to the area in which the inspector conducts inspections
activity.

(3) Persons performing the evaluation, control and decide
under this Act or participate in professional activities within such
assessment, control and decision making,

A) submit to the Institute or the Veterinary Institute on request annually
or before exercise activities, declarations of financial, business or other relationships
to operators, holders of
registration or applicants under this Act, which could affect their impartiality
in carrying out those activities;
this declaration covers a period of at least five years prior to this declaration;
any changes to the data in the declaration shall be notified; these statements are available on request
open to the public and the Agency; Data from this statement take into account
Institute or the Veterinary Institute in assigning specific tasks to individuals in
performance of activities under this Act,

B) are obliged to keep confidential all information with which
acquainted during their operations, in accordance with European Union requirements,
legislation and international agreements

C) in the case of checks abroad must be familiar with the principles of organization and management
supervised activities in the Member State
or in a third country.
Part 3


Rights and Obligations of the operator

§ 23

(1) An operator shall

A) when dealing with drug use and procedures comply with the requirements of the European Pharmacopoeia
^ 4) and Czech Pharmacopoeia, follow
Community herbal monographs, guidelines of the Commission and agencies and guidance
holder of the marketing authorization of a medicinal product determined in accordance with this
decision

B) the occurrence of adverse drug reaction or defects in quality
drugs or excipients assess their seriousness and
if necessary, take all available measures to ensure
axle and limiting the adverse effects of the drug or auxiliary
substances to the lowest possible level, including possible withdrawal from circulation;
measures taken immediately notify the Institute or the Veterinary Institute, where
is a quality defect or serious or unexpected adverse
effect

C) promptly notify the Institute, in the case of human medicine or
Veterinary Institute of veterinary medicine, a suspect
quality defects of drug or excipient, which lead to the withdrawal || | drug or excipients from circulation

D) provide the Institute or Veterinary Institute as per their requirements without charge
documents and information necessary to perform their duties according
§ 13 paragraph. 3 point. b) and § 16 par. 3 point. b) and if necessary
verify the quality of the medicinal product sample;
this obligation does not apply to transfusion products

E) to take all measures necessary to download
medicinal product from the market, in the event that the marketing authorization holder shall take upon the occurrence
adverse effect or quality defect of a medicinal product, medicinal
or excipients measures involving the withdrawal of

Product to the extent and in the manner that the holder of the registration
operators communicate; the adoption and implementation of these measures
not affect the provisions of the Law on Product Safety
operator but yet, if a human medicinal product must
proceed in accordance with the assessment of the degree of hazard in accordance with § 13 para. 2 | || point. k), if such an evaluation conducted by the Institute and published.

(2) An operator shall not be placed on the market and put into circulation or used in
provision of health care or veterinary care, pharmaceuticals

A) with an expired shelf life,

B) a quality defect or

C) which thus ruled Institute or Veterinary Institute.

(3) The operator, with the exception of vendor selected medicinal products,
is entitled to protection in the implementation of medicines to control the objects that
used for the production, preparation, treatment, control or distribution of drugs
persons entering or exiting from these objects, their luggage and vehicles
entering these objects or from
commuting. These persons are obliged to abide tours.

(4) vendor of selected medicinal products shall

A) ensure that each natural person selling reserved medicinal products
received a certificate of professional competence seller reserved
medicinal products, for medicinal products for human or veterinary medicines
; in the case of human medicinal products
not required to obtain a certificate of professional competence
vendor of selected medicinal products by pharmacists and pharmaceutical assistants
^ 29), in the case of veterinary medicinal products, the certificate || | proficiency vendor of selected medicinal products to replace
proof of graduation from an accredited medical
master's degree program in pharmacy pursuant to the Act on the conditions of obtaining and recognition
specialized qualifications or accredited
master's degree program in veterinary medicine
or an accredited master's degree program in veterinary hygiene and ecology
,

B) comply with the rules of good practice of vendors of selected medicinal products and
within 15 days notify the Institute or the Veterinary Institute
launch of a business address or registered office and address
establishment or termination of activities, || |
C) only sell reserved medicines

D) exclude from the sale of reserved medicinal products, if

First He was notified of the defect; shall immediately inform
Institute or Veterinary Institute, sent to the Institute or the Veterinary Institute
sample of a medicinal product and
follow the instructions of the department,

Second elapsed time of their applicability,

Third It violated their integrity or outer packaging

Fourth missing or not readable label their packaging

Fifth not comply with the conditions under which they are to be stored
medicines or

6th so decided Institute or the Veterinary Institute in accordance with § 13 para. 2 point. c)
d) or e) or pursuant to § 16 para. 2 point. c) or d) or under
proceedings to amend a registration under § 35

E) forward unusable medicine dedicated to deletion according to §
88 and 89 in accordance with special legal regulations 34)

F) purchase reserved medicinal products only from distributors or
manufacturers of these medicines

G) keep a complete and conclusive records of inventory, purchase and sale of selected medicinal products
itemized allowing
distinguish dosage form, quantity of drug contained in a unit
weight, volume or pharmaceutical form, type packaging and package size
medicine, including the code of the medicinal product, and keep this
records along with proof of purchase, storage and sale of reserved
medicines for 5 years.

(5) The implementing legal regulation stipulates the content, number of lessons and
way of keeping vocational course vendors of selected medicinal products and
rules of good practice of vendors of selected medicinal products.

(6) Operators conducting nonclinical safety studies of drugs are
comply with the rules of good laboratory practice in accordance with § 6 para. 4;
Good laboratory practice in the implementing legislation.

When conducting non-clinical safety studies, operators must
proceed in accordance with special legal regulations 35).

§ 24

Obligations for the collection, testing, processing, storage, dispensing,
distribution and importation from third countries or export to a third country
human blood, its components and raw materials for further manufacture and transfusion products

(1) Holders of marketing authorization for a medicinal product which contains
raw materials from human blood or its components and in the manufacture of such raw materials
were used, and the operators

A) involved in the manufacture of transfusion products and raw materials for further
production, including their production for clinical trials,

B) uses in the manufacture of medicines or
importing from third countries for the manufacture of medicinal products or
distributing human blood, its components or raw materials for further production

Provide for the collection, testing, processing, storage, distribution and
imports from a third country or export to a third country of a human blood
its components, raw materials for further manufacture and transfusion products
adherence to quality and safety according to § 67

(2) Persons under paragraph 1, of the person issuing transfusion products and
person providing health services lead to the extent and in the manner specified
implementing regulation
records to ensure traceability of blood products from donor to recipient and vice versa
raw materials for further production from the donor to producers and vice versa, including data on unused
transfusion products and raw materials for further production;
These records are kept for at least 30 years and are available on request
manufacturers transfusion product or raw materials for further manufacture
. These persons are obliged to provide records so that throughout this period
protected against unauthorized by consulting or other unauthorized
waste and loss, so that this obligation has been fulfilled even after
eventual demise of these persons.

(3) Persons referred to in paragraph 2, in the event of serious adverse
reactions or serious adverse events or suspected obliged

A) take all available measures to ensure the axle and
limit the adverse effects to a minimum,

B) promptly report such findings or suspicions to the extent and
manner stipulated by the implementing legislation of the Institute and persons
will contribute to the solution

C) maintain and make available documentation relating to such determination or
suspicion, including documentation containing personal data ^ 36)

D) provision of such finding or suspicion report and provide it
Institute and the persons involved in the case.

In order to implement these obligations, the person referred to in paragraph 2
procedure for monitoring and management of serious adverse reaction and serious adverse events
or suspicion of such reactions and events.
Transfusion services and blood banks shall forward to the Institute for
each calendar year a report summarizing the data in this paragraph and paragraph
second The implementing regulation lays down rules and procedures to the extent
monitoring and management of serious adverse reactions, serious adverse events
or suspicion of such reactions and events and content and deadlines
messaging and data of the Institute on these events.

(4) transfusion products or raw materials for further manufacture may
operators referred to in paragraph 1 shall be imported from a third country, export to a third country or
distribute between Czech Republic and another Member State
only with the prior consent Ministry of health
unless a transit ^ 37). Consent is issued for a specific period;
request for consent must contain data about the applicant as well as data
specifying the subject of the application and its justification; a range of data sets
implementing legislation.

(5) The Ministry of Health approval issued pursuant to paragraph 4, if


A) such imports from a third country or export to a third country such
distribution concern transfusion products or raw materials for further manufacture
which were made contrary to the provisions of this Act and may endanger health
and people's lives,

B) export to third countries or imports from a third country is given priority over
distribution within the European Union,


C) in the case of imports for the needs of the health services available
sufficient quantities of transfusion products complying with this Act
which are made of the donation in the Czech Republic

D) export to a third country or distribution from the Czech Republic to another Member State
compromising the sovereignty of the Czech Republic in relation to ensuring
haemotherapy,

E) such imports from a third country or export to a third country such
distribution of transfusion products or raw materials for further manufacture
should be carried out from samples other than from voluntary free blood donors
except with the permission for the export of plasma containing anti-D antibodies;
For unpaid blood donors is regarded as a donor, which was granted
payment pursuant to the provisions on the treatment of blood or its components
Act on Specific Health Services-37a), or

F) its release could endanger life or health of persons
located in the Czech Republic.

(6) The Ministry of Health approval pursuant to paragraph 4 removes, if


A) the consent was issued based on false or incomplete information,

B) are not complied with conditions of the issued consent

C) the products are imported from a third country or export to a third country leads to
threat to health and life of humans or

D) the operator to whom the consent was given, he has seriously breached
operator's obligations under this Act.

(7) The Ministry of Health may withdraw consent pursuant to paragraph 4
if the operator to whom the consent was granted, have failed
accordance with the approval granted to him on the previous period.

(8) The operator who has been granted consent pursuant to paragraph 4
informs the Ministry of Health about the actual imports from third
countries or exported to third countries or distribution within the European Union, and it
10 days after the expiry of the consent given.
Implementing legal regulation stipulates the method of providing this information and its contents.

(9) The operator pursuant to paragraph 1 may make a distribution
transfusion product between the Czech Republic and another Member State
import of a transfusion product from a third country or to export
transfusion product to a third country without prior
won approval in accordance with paragraph 4, or medical service provider ^ 9)
can ensure a transfusion product from a Member State if it is justified
emergency and urgent need to ensure the transfusion
preparation for the provision of medical services to individual patients .
In this case, the operator of a blood product imported or exported
or medical service provider who can ensure
inform the Ministry of Health
later than 15 days. The implementing regulation lays down the method of providing this information
and its contents.

(10) An operator who has been granted consent pursuant to paragraph 4, is obliged
imported or exported, except for transit ^ 37)
submit this agreement to the customs office as declarant ^ 38) and || | it yourself or through a direct representative ^ 39).

§ 24a

Proceedings in cases of doubt whether a medicinal product or another product


(1) Application for issuing decisions under § 13 para. 2 point. h) or §
16 paragraph. 2 point. f) in addition to the general requirements for application contains

A) the indication of the product name, product forms and pack sizes

B) qualitative and quantitative composition of the product; in the case of plants with the names
primarily in Latin specifying generic and generic name,
hereafter shall indicate the part of the plant and the form in which the plant is contained in
product; the extract is also stated the ratio of extract and crude drugs;
U chemicals indicate the common name

C) the intended use of the product

D) the mechanism of action of the product

E) the homeopathic manufacturing procedure, if it is a homeopathically diluted
product

F) the text on the packaging and other written information distributed with the product,

G) information on the classification of the product in other countries

H) if the product is marketed in the Czech Republic
dossier on the basis of the product in question was launched.

(2) To examine incentives that could be the reason for the initiation of
decision under § 13 para. 2 point. h) or pursuant to § 16 para. 2

Point. f) ex officio, are persons who have access to information pursuant to paragraph 1
obliged to request these data provide
Institute or the Veterinary Institute, within the period laid down therein.

(3) As part of the operative part of the decision in accordance with § 13 para. 2 point. h) or
according to § 16 para. 2 point. f) the information specified in paragraph 1 letter.
A), b), c) and f).

(4) If, following consideration of all the characteristics of a product clearly determine whether
is a medicinal product or another product ^ 88), it holds that a
medicine.
TITLE III


Registration of medicinal products and issues with their registration RELATED


§ 25

(1) The medicinal product may be placed on the market in the Czech Republic, if he was not granted


A) the registration of the Institute, in the case of human medicine or
Veterinary Institute, in the case of a veterinary medicinal product or

B) registration procedure under the directly applicable regulations of the European Union
^ 24).

If a medicinal product has been granted an authorization pursuant to subparagraph a)
or b) be any additional strengths, pharmaceutical forms, routes of administration
and other animal species, in the case of a veterinary medicinal product
granted in accordance with subparagraph a) or b). All these
registration are referred to as global marketing.

(2) Registration is not

) Medicinal products prepared in a pharmacy or at workplaces where you can
prepare medicinal products in accordance with § 79

First accordance with a medical prescription for an individual patient

Second in accordance with the Czech Pharmacopoeia or based on technological regulation
and intended to be supplied directly to patients at the pharmacy, where the preparation
place, or a pharmacy that is authorized from this pharmacy
subscribe pursuant to § 79 par. 9, or intended to be supplied directly
veterinary doctor or keeper of the animals, or intended for direct use in
healthcare providers, for whom the preparation took place

B) medicinal products intended for research and development,

C) intermediate goods destined for further processing by
medicinal products

D) radionuclides in the form of sealed sources,

E) whole blood, plasma or blood cells of human origin and blood
preparations, except for plasma prepared by a method involving an industrial
procedure

F) medicated feed

G) veterinary autogenous vaccines

H) radiopharmaceuticals prepared in accordance with the instructions of the holder of the registration
exclusively from authorized radionuclide generators, kits or radionuclide precursors
for immediate use in nuclear medicine
health providers authorized to perform activities
by special legislation, 13)

I) medicinal products for advanced therapy allowed under hospital
exceptions.

(3) The registration under paragraph 1 shall also be required for radionuclide
generators, kits, radionuclide precursor
radiopharmaceuticals and industrially prepared radiopharmaceuticals.

(4) For the purposes of registration of medicines means

A) reference medicinal product medicinal product authorized in
meaning of paragraph 1 and on the basis of a request pursuant to § 26

B) generic medicinal product which has the same qualitative and quantitative composition
terms of active substances and the same pharmaceutical
form as the reference medicinal product and which has, except
where possible demonstrate that the generic medicinal product meets the relevant criteria laid down by the relevant guidelines
Commission and agencies
demonstrated bioequivalence with the reference medicinal product relevant studies
bioavailability; Different salts, esters, ethers, isomers, mixtures
isomers, complexes or derivatives of the active substance shall be considered as
same active substance, unless they differ significantly in properties with regard to
safety or efficacy; Various oral dosage forms
immediate release shall be considered as one and the same pharmaceutical form.

Application for registration

§ 26

(1) An application for registration made by physical or legal person (hereinafter
"registrant") individually for each pharmaceutical form and strength
medicine Institute, in the case of a human medicinal product or | || veterinary Institute of veterinary medicine.


(2) An application under paragraph 1, the Institute or Veterinary Institute does not
in a case arising § 25 par. 1 point. b).

(3) In the event that an application for registration of the same medicinal product in addition
Czech Republic submitted in another Member State, the procedure
in accordance with the provisions on mutual recognition of registrations.

(4) The authorization may be granted only to the registrant who has
resident or established ^ 21) in the territory of a Member State.

(5) an application for registration must be submitted the following information and documentation
:

A) the name of the product,

B) qualitative and quantitative particulars of all the constituents of the medicinal product, including
international non-proprietary name recommended
World Health Organization, where such name exists, or
stating the relevant chemical name, and whether the medicinal product
contains an addictive substance or precursor ^ 40)

C) evaluating the potential risk posed
medicinal product for the environment and any specific measures to reduce such
risk

D) a description of the manufacturing method,

E) therapeutic indications, contraindications and side effects

F) dosage, dosage form, method and route of administration and expected duration
applicability; in the case of a veterinary medicinal product shall be
dose for all species for which the medicinal product
intended

G) the reasons for the precautionary and safety measures, if necessary
is done for the storage of the medicinal product, its administration to patients or
animals and disposing of waste, together with reference to any possible risks posed
medicine environment; in the case of
veterinary medicine, pointing also to all potential risks associated with
medicinal product for human, animal or plant

H) a description of the control methods employed by the manufacturer

I) written confirmation that the manufacturer of a medicinal product
verified by audits by the manufacturer of the active substance with
good manufacturing practice and guidelines according to § 64 point. l) in the case of a human medicinal product
; This written confirmation must include the date of the audit
a declaration that the outcome of the audit confirms that the manufacturing complies
with good manufacturing practice and these instructions

J) results

First pharmaceutical (physico-chemical, biological or microbiological
)

Second pre-clinical (toxicological and pharmacological)

Third clinical trials

Fourth safety and residue tests, in the case of veterinary medicinal
product

A) a summary of the pharmacovigilance system registrant, which is part


First demonstrate that the registrant has
qualified person responsible for pharmacovigilance

Second indication of the Member State in which the qualified person resides
and perform their tasks,

Third the contact details of the qualified person,

Fourth A declaration signed by the registrant that has
necessary means to fulfill the tasks and responsibilities in ensuring
pharmacovigilance

Fifth the place where it is kept basic document
pharmacovigilance system for the medicinal product

L) The risk management plan describing the risk management system which the applicant for
authorization for the medicinal product introduced, together with a summary
this plan; in the case of a veterinary medicinal product shall be submitted with the plan
risk management only if the risks associated with veterinary medicine
can not be controlled by other measures or conditions specified in the registration
pharmacovigilance or veterinary medicine, || |
M) an affidavit confirming that clinical trials carried out outside
European Union meet the ethical requirements equivalent to those laid down in
§ 51 et seq., In the case of human medicine

N) a draft summary of product characteristics, pattern of internal and external packaging
medicinal product together with the draft package leaflet; in the case of
human medicine in the implementing legislation and cases
method of presentation of the conclusions assessment of readability and clarity
leaflet carried out in cooperation with target groups
patients


O) the identification of all manufacturers and production sites and documents that each
manufacturer is authorized to manufacture medicinal products

P) copies:

First All decisions on marketing authorization of a medicinal product
obtained in another Member State or in a third country, a summary
safety data, including data contained in the periodic
safety update reports, where available, and || | reports of suspected adverse reactions, together with a list
Member States in which it is administered and judged registration request

Second SPC proposed by the registrant or
approved by the competent authority of the Member State concerned and
leaflet proposed by the applicant for registration or approved by the competent authority of the Member
State

Third any decision to refuse authorization in the EU or in a third country
stating the reasons for such a decision,

Q) proposed withdrawal period, in the case of a veterinary medicinal product
intended to be administered to animals which produce animal products intended for human consumption
,

R) documents proving that at least 6 months prior to filing an application for registration has been
Agency submitted a valid application for the establishment
maximum residue limits in accordance with applicable regulations of the European Union
^ 5) jde- of veterinary medicinal products intended for administration
animals, producing animal products intended for human consumption which
contain pharmacologically active substances so far not listed in Annex I, II or III
this directly applicable regulation, except in accordance with §
31 par. 11,

S) proof of payment of the fee for filing an application for registration
by special legislation, 41), or a document on compensation
expenses under § 112 if requested in advance

T) copies of documents establishing the medicinal product as a medicinal product
orphan ^ 42), together with a copy of the relevant
Agency's opinion, in the case of medicinal products for rare diseases.

(6) The documents and information concerning the results of the pharmaceutical and
preclinical tests and clinical trials referred to in paragraph 5
point. j) points 1-3, are accompanied by detailed summaries in accordance with § 27 para.
12th In the case of veterinary medicinal products are also accompanied by detailed summaries
to documents and information concerning the results of tests for safety and residues
pursuant to paragraph 5. j) paragraph 4 and possibly
evaluation of the impact on the environment pursuant to paragraph 5. C).

(7) the compilation and documentation of the application for registration of the applicant for registration
further based on the guidelines of the Commission and agencies.
Draft summary of product characteristics, package leaflet and draft proposals
markings on the outer and inner packaging of a medicinal product shall be submitted in the Czech language
if the Institute or the Veterinary Institute decides otherwise pursuant to § 38;
Other documentation may be submitted in English or Slovak
language or in another language, the Institute or the Veterinary Institute after
agreement with the registrant determines. If during the registration
management changes submitted data and documentation, especially
data referred to in paragraph 5 point. p), the registrant must these changes
immediately notify the Institute or the Veterinary Institute. In the case
extensive changes to the data and documentation Institute or the Veterinary Institute may
require a new application for the registration and management of initial application
stops. The implementing regulation lays down detailed specification
content and presentation of data and documentation for the application.

§ 27

(1) The registrant is not required to submit the results of preclinical
tests and clinical trials, and in the case of veterinary medicinal products, the results
safety and residue tests, if
can demonstrate that the medicinal product is a generic
reference medicinal product which is or has been authorized under the regulations of the European Union
for at least eight years in a Member State or the procedure laid directly applicable regulation
EU-24). In this case
not submit information pursuant to § 26 paragraph. 5 point. j) points 2-4 and
not affect the legal protection of industrial property and business secrets.
Generic medicinal product authorized pursuant to this provision shall not be placed on

Market until the expiration of 10 years from first authorization of the reference product in
any Member State or the European Union or, in the case
veterinary medicinal products authorized for fish, bees and other
species designated by the Commission, 13 years since the first authorization of the reference product
in any Member State or the European Union. These periods
is only 6 years old when the application for registration of such
reference product was submitted before 30 October 2005
not a reference product authorized in accordance with the procedure
directly applicable Community regulation 24 ^ ).

(2) The period of 10 years pursuant to paragraph 1 shall be extended by decision

A) for Medicinal maximum of 11 years if the holder
decision on the authorization of the reference product obtains during the first 8
years of the 10-year authorization for one or more new therapeutic indications
which are during the scientific evaluation prior to their authorization
considered significant clinical benefit in comparison with existing therapies
procedures

B) for veterinary medicinal products by one year for each extension
registration of a new kind of animal from which are obtained
animal products intended for human consumption, but not exceeding 13 years if
the marketing authorization holder of the reference product obtains such
extensions during the first five years of this period of 10 years, and if
veterinary medicinal products that are designed for at least 1
kind of animal from which they are obtained animal products intended for human consumption
, and containing a new active substance which was not in the European Union
registered by 30 April 2004; extension of the period of 10 years at 11, 12 or 13 years
shall be recognized only if the holder of the registration
was also the applicant for the establishment of maximum residue limits
for the species, which is subject to registration.

(3) The provisions of paragraph 1, first sentence and second to also apply if
reference medicinal product was not authorized in the Member State in
which the application for the generic authorization is submitted. In this case
registrant shall request the name of the Member State where the
or the reference medicinal product is authorized. If the application for registration
submitted in the Czech Republic, the Institute or the Veterinary Institute
request from the competent authority of another Member State to confirm that
reference medicinal product is or has been authorized and the full composition of the reference product
or other documentation. If such confirmation is requested
authority of another Member State, the Institute or the Veterinary Institute
transmit a confirmation and further information
within 1 month of receipt of request.

(4) In cases where the medicine is not a generic or not
bioequivalence demonstrated through bioavailability studies or in case
changes to the active substances or drugs, therapeutic indications, strength, dosage form or route
administration compared with the reference medicinal product,
Institute or the veterinary Institute will present the results of relevant
preclinical tests or clinical trials and, in the case of
veterinary medicines, as well as the results of relevant tests for safety and residues
. If the various salts, esters, ethers, isomers, mixtures of isomers
complexes or derivatives of the active ingredient
properties related to safety or efficacy differs significantly
applicant must submit additional information providing proof of the safety || | or effectiveness of various salts, esters or derivatives of the active substance
.

(5) If a biological medicinal product which is similar to a reference
biological medicinal product does not meet the definition of a generic terms,
mainly due to differences in raw materials or differences in manufacturing processes
such biological medicinal product and the reference biological
medicinal product must be submitted
results of relevant preclinical tests or clinical trials relating to these conditions
. Results of other preclinical tests and clinical trials
contained in the dossier of the reference biological medicinal product
are made. The implementing legal regulation stipulates the scope
additional data to be submitted. These data must be

Accordance with the relevant guidelines of the Commission and agencies.

(6) If a request for

A) the registration of new indications for a medicinal product containing a well established substance
and have made significant preclinical tests and clinical trials
related to this new indication, the Institute shall take into account
results of these studies when assessing request under paragraph 1
submitted by another registrant for a period of one year from the grant
authorization for another medicinal product with the indication;
period of protection pursuant to the preceding part of the sentence can not be repeated

B) extension of authorization for a veterinary medicinal product which is referred to in paragraph 7
registered for at least one species of animal from which they were obtained
animal products intended for human consumption, another such
species for that the applicant has submitted the results of new tests
residues in accordance with applicable regulations of the European Union ^ 5)
together with the results of new clinical trials, the results of these tests must take
Veterinary Institute into account when considering an application by
paragraph 1 for another applicant for a period of 3 years after the granting
registration for which they were submitted.

(7) The registrant is not required to submit the results of preclinical
tests or clinical trials and, in the case of veterinary medicinal products, the results
safety and residue tests, if it can
show that the active ingredients of the medicinal product have
well established medicinal use in the European Union for at least 10 years
recognized efficacy and an acceptable level of safety; scope and method of proof
well established medicinal use in the implementing legislation.
In such a case, do not provide information pursuant to § 26 paragraph. 5 point. j) points
2-4, instead of the results of preclinical tests and clinical trials
be submitted to the relevant scientific literature, and shall not affect the legal protection
intellectual property and trade secrets.
In the case of veterinary medicinal products, especially for proving safety
use assessment reports published by the Agency in connection with the evaluation
application for the establishment of maximum residue limits in accordance with a directly applicable regulation
EU-5) .

(8) In the case of medicinal products containing active substances that are
composition of authorized medicinal products but not hitherto used in
combination for therapeutic purposes must be submitted
results of preclinical tests or clinical trials and in the case
veterinary medicinal products, the results of safety and residues
regarding this combination according to § 26 par. 5 point. j)
but is not required to submit results of preclinical tests or clinical assessment
relating to each individual active substance.

(9) For the purposes of assessing applications relating to other medicinal products
having the same qualitative and quantitative composition in terms of
active substances and the same pharmaceutical form, the holder may
registration after authorization give consent to the use
pharmaceutical, preclinical and clinical documentation contained in the dossier
medicine.
In the case of veterinary medicinal products, the marketing authorization holder
give their consent for the use of documents relating to safety and residues.

(10) The registrant is not required to submit, in the case of immunological veterinary medicinal products
, the results of some of the evaluations carried out
in the target species in field conditions, if these trials can not be conducted
s regard to European Union regulations regarding
some serious animal diseases ^ 15). In this case
not submit information pursuant to § 26 paragraph. 5 point. j) points 2-4 and the applicant states in the application
reasons why such results have been presented.

(11) for registration under paragraphs 1 to 5 may not be in the summary of product
included those parts of the summary of the reference medicinal product
referring to indications or dosage forms which were at the time of the introduction of generics
the market still covered by patent law ^ 43).
Implementing legal regulation stipulates the scope and the format of data that are contained
SPC.

(12) A registrant shall ensure that detailed summaries in accordance with § 26

Paragraph. 6 drawn up and signed by experts with the relevant technical or
professional qualifications, which shall in a brief curriculum vitae. Persons
who have technical or professional qualifications referred to in the previous sentence,
justify any use made of the scientific literature referred to in paragraph 7. The purpose
detailed summaries is to summarize pharmaceutical, preclinical and clinical data
reports. The implementing legal regulation stipulates the scope
detailed summaries.
Heading left


§ 28

Simplified registration procedure for homeopathic products for human use

(1) The simplified registration procedure under which the
does not require proof of therapeutic efficacy, subject only to the human homeopathic products
satisfying the following conditions

A) they are administered orally or externally,

B) on the labeling of the human homeopathic product or in
any information that concerns him is not listed therapeutic indication

C) dilution can guarantee the safety of the human homeopathic product;
Implementing regulation lays down the procedure for dilution of the human homeopathic product
.

(2) The application for a simplified registration procedure may also apply to more
human homeopathic products derived by dilution from the same
homeopathic substance or mixture of substances and differing only in the degree of dilution.
This request shall be submitted for each pharmaceutical form individually.

(3) The application for simplified registration must contain data about the applicant
further details specifying the subject of the application and its justification;
the application shall be accompanied by documentation evidencing the safety of human
homeopathic product, the pharmaceutical quality and homogeneity among
runs. The particulars of this application shall apply mutatis mutandis
provisions of § 26 par. 5 excluding letters c), e), g) point. j) point 3
point. k) to n) regarding the draft summary of product characteristics.
Implementing legal regulation stipulates the scope of data and content of the submitted documentation.

(4) In the case of human homeopathic products authorized
simplified registration procedure referred to in paragraph 1 shall be in addition
statements pursuant to § 37, indicated on the packaging information "Homeopathic medicine
without approved therapeutic indications"; the same information must be provided
package leaflet.

§ 28a

Management of specific human homeopathic preparations

(1) Specific human homeopathic products are homeopathic
products intended for administration orally or externally to alleviate or treat
less severe symptoms or less serious illnesses that require
supervision or medical intervention.

(2) The application for registration of a specific human homeopathic medicine
be accompanied

A) information and documentation pursuant to § 26 par. 5 point. a), c) to h), k), o), p
) and t) and the results of pharmaceutical tests referred to in § 26 par. 5 point.
J) of point 1 and § 26 par. 6 and

B) qualitative and quantitative composition stating
scientific name of the stock or substances, followed by the degree of dilution
expressed pharmacopoeia symbol.

(3) For specific human homeopathic products is not an applicant for registration
obliged to submit the results of preclinical pharmacological and toxicological tests
provided that it is able to demonstrate
safety of homeopathic scientific data demonstrating the safety
based on the published scientific literature.

(4) For specific human homeopathic products, the applicant for registration
prove homeopathic use and therapeutic indications
medicine or homeopathic, from which the product is composed
reference to the publication recognized in Member States
traditional homeopathic practice or research, which is referred to as
homeopathic method of proving and is based on the administration of the substance for human
order to determine the symptoms caused by the substance.

§ 29

Proceedings of veterinary homeopathic preparations

(1) The simplified registration procedure
subject to veterinary homeopathic products that meet the following conditions

A) they are administered by a route specified in the European Pharmacopoeia or the pharmacopoeia
force in the Member States

B) have on the packaging or in any information that relates to the relevant
veterinary homeopathic product indicated no specific

Therapeutic indications or other information relating to the therapeutic indications,
unless the Commission decides otherwise ^ 44)

C) they are not veterinary immunological homeopathic products,

D) has a sufficient degree of dilution to ensure that the veterinary homeopathic product
safe;
such veterinary homeopathic products may not contain more than one ten-thousandth
basic homeopathic substances, unless the Commission decides otherwise ^ 44).

Use of the simplified registration procedure of veterinary homeopathic products
not affect the requirements laid down by the directly applicable EU regulation
^ 5).

(2) The application for simplified registration must contain data about the applicant
further details specifying the subject of the application and its justification.
The application shall be accompanied by documentation evidencing particular security
veterinary homeopathic product, the pharmaceutical quality and
homogeneity between batches. The implementing regulation lays down
scope of data and content of the submitted documentation. The authorization
veterinary homeopathic product down Veterinary Institute
method of dispensing this product.

(3) For veterinary homeopathic products referred to in paragraph 1
adduces evidence of therapeutic efficacy and a draft summary of product characteristics.

(4) The application for a simplified registration procedure under paragraph 1
apply the provisions of § 28 para. 2 mutatis mutandis.

(5) In the case of veterinary homeopathic products authorized
simplified registration procedure under paragraphs 1 and 2 must, in addition
statements pursuant to § 37, indicated on the packaging information "Homeopathic veterinary
product without approved therapeutic indications ';
same information must be given in the leaflet.

§ 30

Procedure for traditional herbal medicinal products

(1) Traditional herbal medicinal products subject to a simplified registration procedure
under this provision only if they meet the criteria
registration according to § 25 to 28
Traditional herbal medicines are those human herbal medicines ,
which meet the following conditions:

) Are intended to be administered orally, topically or by inhalation,

B) are intended to be administered only in a particular strength and dosage

C) they have indications exclusively appropriate
traditionally used herbal medicinal products intended and designed on the basis of their composition and purpose
for use without medical supervision
required for diagnostic purposes or for prescription or monitoring of treatment ,

D) the elapsed period of traditional use as laid down in paragraph 3.
E)

E) data on traditional use of a medicinal product are sufficient
; in particular, it is shown that the product under the conditions
use is not harmful and that the pharmacological effects or efficacy of the medicinal product
are obvious on the basis of long-term use and experience
.

(2) Traditional herbal medicines can be registered
simplified procedure under paragraph 1, even when they contain vitamins or minerals
if the safety of these vitamins and minerals
sufficiently demonstrated and their effect is ancillary to that of herbal active ingredients
regard to the indication.

(3) The application for registration simplified procedure provided for in paragraph 1 shall be accompanied


A) information and documentation pursuant to § 26 par. 5 point. a) to h), j), n), o) and
s) and the results of the pharmaceutical tests referred to in § 26 par. 5 point. j)
Section 1

B) a draft summary of the product to the extent determined by the implementing regulation
,

C) the data referred to in paragraph 1. e) relating to the combination according
§ 2. 2 point. m) or pursuant to paragraph 2, if the individual active ingredients
sufficiently known; if this condition is met, it must be
also enclosed information relating to the individual active ingredients,

D) list of countries in which the registrant is granted
registration or authorization for placing the medicinal product on the market in another
Member State or in a third country, and details of any withdrawal of the application back
or the decision to deny, suspend or cancel
registration or authorization in the European Union or in a third country and the reasons
all these decisions

E) bibliographical or scientific proof that the medicinal product or

Corresponding product referred to in paragraph 4 was the date of submission
used for the treatment for at least 30 years, including at least 15 years
European Union

F) a bibliographic review of safety data together with summaries by
§ 26 paragraph. 6th

Implementing regulation provides further scoping and data editing
and documentation for the application.

(4) The corresponding product has the same active ingredients, irrespective
excipients used, the same or similar intended use
equivalent strength and posology and the same or similar route of administration as
medicine, for which application is submitted.
The requirement to show medicinal use of the medicinal product or
adequate preparation for at least 30 years is satisfied even when the
medicine or a corresponding product has been placed on the market without
granting authorization under this Act. This requirement is also
satisfied if the number or quantity of ingredients during this time
reduced. If the concerned medicinal product or equivalent product
used in the European Union less than 15 years, but otherwise satisfies the conditions for registration
simplified procedure provided for in paragraph 1
Department will ask the Committee on Herbal Medicinal Products for an opinion ^ 45) .
Proceedings are interrupted on the day of departure, requesting an opinion of the Committee on Herbal Medicinal Products
until the Department receives an opinion; the interruption
Management Institute shall inform the applicant.

(5) The provisions of the mutual recognition procedure shall be used only for registration
simplified procedure provided for in paragraph 1
similarly under the assumption that

A) Community monograph ^ 45) medicinal plants
created by the Committee on Herbal Medicinal Products, or

B) Traditional herbal medicinal product consists of herbal substances,
herbal preparations or combinations thereof contained in the list
pursuant to paragraph 7, with

First herbal substances means plants whole, fragmented or cut
, plant parts, algae, fungi, lichen in an unprocessed,
dried or fresh; as herbal substances are also considered
vegetable secretions, which have not undergone any processing;
herbal substances are defined by the plant part used and the botanical name
by valid scientific binomial nomenclature including genus, species,
author and, if necessary, subspecies and varieties

Second herbal preparations means products derived from the processing
herbal substances or herbal substances to treatments such as extraction,
distillation, fractionation, purification, concentration or fermentation
; herbal preparations include comminuted or powdered
herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates
.

(6) An application for registration of a simplified procedure under paragraph 1
refused if, during the registration procedure proves that
herbal medicinal product fulfills the conditions set out in paragraphs 1 to 3
or that || |
A) qualitative or quantitative composition is not
declared,

B) the indications do not meet the conditions set out in paragraph 1

C) may be under normal conditions of use, harmful

D) data on traditional use are insufficient, especially if
pharmacological effects or efficacy obvious on the basis of long-term use and experience
or

E) the pharmaceutical quality is not satisfactorily demonstrated.

Decision rejecting the application for registration
simplified procedure provided for in paragraph 1, including its justification Department notifies the Commission, and it
within 15 days from the date of entry into force of the decision, and on request also to everyone
MSCA.

(7) If an application for registration of a simplified procedure in accordance with paragraph 1
refers to a medicinal product containing a herbal substance,
herbal preparation or a combination thereof, which are listed in
herbal substances, preparations and
combinations thereof for use in traditional medicines, it is not necessary to submit the data referred to in paragraph 3
point. d) to f). If a herbal substance,
medicine or combination from the list in this paragraph
omitted Institute marketing authorization granted under the first sentence canceled if
MAH within three months from the date of launch of the plant

Substance, herbal preparation or a combination thereof from a list
submit an application for change of registration and provide data and documentation referred to in paragraph 3
point. d) to f).

(8), labeling and package leaflet of a traditional herbal medicinal product must
off data according to § 37 and 38 contain a statement

A) "The use of traditional herbal medicinal product is
based exclusively on experience from long-term use,"
this information must also include any advertising on traditional herbal medicinal
product

B) which encourages users to consult a doctor if symptoms
disease when using traditional herbal medicinal product
persist or if adverse effects not mentioned in the package
information.

Institute may, as part of the registration procedure require the labeling
package or leaflet shall also state the nature of the
tradition.

(9) If a medicinal product not yet authorized pursuant to § 27
meet the conditions set out in paragraphs 1 and 2, the MAH
obligated within 180 days from the date when these conditions are met, to request
variation so as to bring them into line with the requirements for registration
traditional medicinal product. If the holder of the registration
fulfill this obligation, the registration of the medicine
expires on the first day of the month following the expiry of the period specified
to apply for change of registration.

(10) If mainstream medicine no longer fulfills the conditions set out in
paragraphs 1 and 2, the marketing authorization holder shall, within
180 days from the date when these conditions ceased to meet, ask for a change || | registration so that was given to comply with the registration in accordance with § 26 and 27. If
MAH fulfill this obligation,
registration of the medicine expires on the first day of the month
following the lapse of the deadline set for
filing an application for change of registration.

§ 31
Registration procedure


(1) The registration procedure Institute or the Veterinary Institute shall assess the completeness
application for registration and within 30 days of receipt
communicate the outcome of this assessment registrants.

(2) If the registration is complete, the Institute or the Veterinary Institute about her
decide within

A) 150 days from the date on which it was communicated to the registrant that his
application was deemed complete, if it is a registration request
medicine according to § 27 para. 1, or

B) 210 days after the date on which it was communicated to the registrant that his
application has been found to be complete, in other cases.

(3) If the Institute or Veterinary Institute, with which an application for registration
finds that the application for registration of the same medicinal product is
being examined in another Member State request is examined and control
stops. Inform the registrant that is necessary to proceed
in accordance with the provisions on mutual recognition of registrations.

(4) Where the Institute or Veterinary Institute informed pursuant to § 26 par. 5
point. p) that another Member State has already been registered
medicinal product which is the subject of an application for registration filed
Institute or the Veterinary Institute shall reject the application unless it was submitted in accordance with the provisions
on the mutual recognition of authorizations .

(5) When assessing an application submitted pursuant to § 26-30
taking into account the specific nature of homeopathic products and traditional herbal products registered
simplified procedure, the Institute or the Veterinary Institute


A) verifies that the submitted data and documentation in accordance with this
law and assess whether the conditions for issuing a
medicinal product, particularly if

First medicinal product may be assessed in accordance with the documentation
as an effective, adequately safe and of a quality

Second benefit from the use of the medicine under the conditions defined
summary of the product outweigh the risks associated with its use,

Third They meet the conditions of good clinical practice, good laboratory practice and
GMP

Fourth Name of product does not contradict its composition and therapeutic effects and
not be confused with the name of another medicinal product already authorized

According to § 25 paragraph. 1, or whose registration has already been submitted to the Institute or the Veterinary Institute
request that has not been finally refused or
to be in line with the intention notified the Agency is requested by
registration procedure of the European Union, and that does not cause a false or misleading impression
when assessing the name of the medicinal product in relation to
target patient group and the SPC,

B) may be subjected to a medicinal product, its starting materials and, if need
, intermediate products or other ingredients
laboratory inspection in order to determine that the control methods employed by the manufacturer and described in the documents submitted
they are sufficient

C), when assessing under paragraph 1 or 2 in the event of deficiencies
invite the registrant to complete the submitted data and documents
or submit samples for laboratory testing by
letter b) | ||
D) verify that manufacturers of medicinal products, including persons importing
medicinal products from third countries, have created conditions or
carry out production in line with the data submitted in accordance with § 26 par. 5
point. d) a check by the methods according to § 26 par. 5 point. h)

E) may allow manufacturers of medicinal products, including those
importing medicinal products from third countries, in justifiable cases
have certain stages of manufacture or controls referred to in point
d) other persons; in such cases the Institute or Veterinary Institute
according to their competence examine appropriate equipment such persons

F) reviewing the classification of a medicinal product for dispensing,

G) examine the labeling on the outer and inner packaging and data in the package
information stores if necessary registrants obligation
place on the inner or outer packaging, or in a leaflet
additional data necessary to regard to the safety of the medicine or
health, including specific warnings relating to the use
medicine with regard to information obtained under
pharmacological testing and clinical trials for the product or within
practical use of the product after authorization,

H) to examine the case of a veterinary medicinal product, whether
analytical method used for detecting residues presented by the applicant in
accordance with § 26 par. 5 point. j) paragraph 4 is satisfactory;
within this assessment Veterinary Institute may request an opinion from the relevant
European Union reference laboratories and national reference laboratories
^ 46).

By verifying the facts listed in subparagraphs d) and e) The Institute or the Veterinary Institute
waived if this is the manufacturer of the Member States
or states with which was signed relevant international agreement ^ 47)
or a producer from a third country in which the facts stated in
points d) and e) certified by the competent authority of a Member State.

(6) If a medicinal product containing genetically modified organism
^ 11), ask the Institute or Veterinary Institute
opinion of the Ministry of Environment to assess the environmental risk
environment by special legislation, 11).
Ministry of the Environment will issue an opinion within 90 days of the date on which the request was received
. By request, this opinion may be waived in the case
such opinion was submitted together with the application for registration or
together with the application for registration was submitted assessment report
risk to the environment from the competent authority of the European
Union.

(7) In the case of human immunological medicines request
Department of the Ministry of Health, and in the case of radiopharmaceuticals require
Institute or the Veterinary Institute, the opinion of the State Office for Nuclear Safety
. The Ministry of Health and the State Office for Nuclear Safety
issue an opinion within 60 days from receipt of request.

(8) The Institute or the Veterinary Institute shall draw up an assessment report on the medicinal product containing
evaluation of the dossier with regard to
results of pharmaceutical and preclinical tests and clinical evaluation
; in the case of human medicinal products, draw up a report on the Institute
assessment with regard to the risk management system and the pharmacovigilance system
of the medicinal product, and in the case of a veterinary medicinal product

Draw Veterinary Institute report on evaluation with regard to the results
safety and residue tests. An assessment report on the medicinal product
Institute or the Veterinary Institute updated whenever they
known new information important for evaluation of the quality, safety or efficacy of the medicinal product
.

(9) the registration procedure will not consider
rights to protect intellectual property and trade secrets, and the fact that
registration has been granted or modified, is not a violation of these rights
Institute or the Veterinary Institute.

(10) The Institute or the Veterinary Institute shall reject the registration if
during the registration procedure after verification of data and documents
listed in § 26 and 27 found that

A) the risk-benefit ratio of the medicinal product can not be considered
favorable; as regards veterinary medicinal product for zootechnical use
^ 48) must be used when assessing the risk-benefit
taken into account the benefits for animal health and welfare and security for
consumer

B) a medicinal product lacks therapeutic efficacy or its therapeutic efficacy is not
registrant sufficiently substantiated

C) qualitative and quantitative composition is not as declared
composition of the medicinal product

D) submitted data or documents do not meet the requirements laid down
this Act or the applicable regulations of the EU-23) or
use of a medicinal product by special legal regulations 17)
or directly applicable regulations of the European Union ^ 49) prohibited, restricted or
is in contradiction with them,

E) data submitted with the application for registration are false,

F) the veterinary medicinal product that is intended to be administered one or more
species of animals, which are obtained from animal products intended for human consumption
contains pharmacologically active substances that are not for the kind
or categories of animals for which it is intended,
listed in Annex I, II or III of the directly applicable European Union
^ 5); When the veterinary medicinal product is intended for multi-species
Animal Veterinary Institute rejects the application for registration only for the
type or category of animals, which are obtained from animal products
intended for human consumption, for which no pharmacologically active
substance listed in Annex I, II or III of the directly applicable European Union
^ 5)

G) the withdrawal period, in the case of a veterinary medicinal product is not
long enough to ensure that foodstuffs obtained from animals
which the veterinary medicinal product has been administered
not contain residues of this product, which could pose a health risk for consumers
, or the withdrawal period was not sufficiently substantiated or

H) immunological veterinary medicinal product is inconsistent with the implementation
veterinary measures with regard to control or animal disease control
^ 18).

(11) Paragraph 10 point. f) does not apply in the case of veterinary
medicinal product intended for animals of the Equidae family, which were
in accordance with applicable regulations of the European Union ^ 16) declared
that are not intended for slaughter for the purpose of human nutrition;
such veterinary medicinal product may not contain pharmacologically active substances
listed in Annex IV to the directly applicable EU-5), nor
not be designed to indicate that is listed in the approved summary data
product authorized veterinary medicinal product
intended for animals of the equidae family.

§ 31a

The authorization may impose Institute, the registrant within a specified period


A) take measures to ensure the safe use of the medicine,
which will be included in the risk management system

B) carried out a post-authorization safety studies

C) record and report suspected adverse reactions which are stricter than
conditions referred to in Chapter Five of this Act

D) modified pharmacovigilance system operated pursuant to § 91 para. 1

E) carried out a post-authorization efficacy studies where concerns relating to some aspects
efficacy of the medicine can not remove
before placing it on the market, or

F) fulfill other obligations or restrictions if necessary to ensure

Safe and effective use of the medicine.

§ 32

The marketing authorization

(1) The decision on registration always contains the product name, registration number
medicinal product information on the holder of the registration
, or about the person MAH
authorize to represent him in matters governed by this Act.
The marketing authorization further includes an indication always

A) classification of a medicinal product for dispensing or
classification of a veterinary medicinal product for dispensing and use

B) whether the product contains an addictive substance or precursor
^ 40).

When granting a marketing authorization the Institute or the Veterinary Institute
inform the marketing authorization holder of the approved summary of product
. In the case of homeopathic products registered pursuant to § 28 or
29, Annex Holder is SPC.

(2) The marketing authorization is valid for 5 years from the date of coming into
power; to § 34a is not affected.

(3) In exceptional circumstances they may be in the marketing
obligations concerning the safety of the medicine,
notification of any incident relating to its use
Institute or the Veterinary Institute and the measures to be taken.
Registration may be granted only if the registrant demonstrates
it is for objective reasons that can be verified
unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use
. The duties assigned to annually assess
. The Institute or the Veterinary Institute on the basis of the results of such an assessment may
Holder amended or repealed.

(4) The authorization may also be stored

A) the obligation to submit the case
immunological medicinal products or blood derivatives before being put into circulation
samples from each batch of bulk or finished medicinal product for examination
Institute or the Veterinary Institute in accordance with § 102 para. 1 ,

B) the obligation to submit periodic safety update reports
medicinal product pursuant to § 96 para. 5 within the deadlines, or

C) any other obligation, the purpose of which is to ensure the quality, safety or efficacy
medicine.

(5) Simultaneously with the issuance of the marketing authorization the Institute or the Veterinary Institute
assign the medicinal product code, which is processed electronically
allow unambiguous identification of each option
medicinal product and is intended to register and goes if a human medicinal product
further for possible identification of pricing and
reimbursements from public health insurance. This code
Institute or the Veterinary Institute shall notify the applicant and publish it as part
list of authorized medicinal products in its information media.

§ 32a

(1) The Institute may ex officio amend the marketing authorization of a medicinal product for human use
so that the holder of the decision imposing the obligation to perform


A) post- authorization safety study if it has doubts concerning
risks of an authorized medicinal product; when they relate
such doubts to more medicines, prompts Institute
after consultation with the Pharmacovigilance Risk Assessment Committee
drugs by directly applicable EU regulations governing the registration procedure
and supervision of medicinal products ^ 91) (hereinafter "the Committee Pharmacovigilance risk assessment
drugs") concerned the MAH,
to conduct a joint post-authorization safety study or

B) post-authorization efficacy studies when the understanding of certain
disease or the clinical methodology indicate that previous evaluation
efficiency should be significantly revised.

(2) Notice of initiation of proceedings pursuant to paragraph 1 shall be in addition to the general requirements
include the objectives and timeframe for submission and conduct
such studies and shall be duly justified. Department of the notice of initiation
management provides the marketing authorization holder in the days to comment
least 30 days. If the Department finds that the procedure referred to in paragraph 1
is not necessary in this case, the procedure for change of registration stops.


(3) If the Department finds no grounds for stopping proceedings, issue a decision, which changed
registration of the product, so that the obligation
imposed pursuant to paragraph 1. a) or b) as a condition of registration.

§ 32b

MAH medicinal product
incorporate all the conditions and obligations imposed on him by § 31a, § 32 par. 3 or
§ 32a of the risk management system. Department inform the Agency of the marketing authorizations granted by
with the determination of the conditions and obligations pursuant to § 31a, § 32 paragraph
. 3 or § 32a.

§ 33

The rights and obligations of the MAH

(1) The marketing authorization holder shall make any necessary adjustments
required to enable the medicinal product to be manufactured and checked
generally accepted scientific methods. These changes are subject to approval or notification
Institute or the Veterinary Institute.
The holder of a marketing authorization shall forthwith provide the Institute
any new information that could lead to a change of data and documentation
submitted in the registration process, especially
inform the competent institution of any prohibition or restriction imposed by the competent
authorities of any State in which the medicinal product is marketed and communicated to him
any other new information which might influence the evaluation
benefits and risks of the medicinal product. Under such information
are considered both positive and negative results of clinical trials or other studies
in all indications and all population groups, as well as information about such
use of the medicine, which is not in accordance with the terms
registration. MAH
a medicinal product shall also ensure that the product information was updated
to match the current scientific knowledge including the conclusions and recommendations
assessment published by the directly applicable European Union
governing procedure registration and supervision of medicinal products
^ 89). The Institute may at any time ask the holder of
authorization for a medicinal product by
submit a copy of the pharmacovigilance system by the MAH
is required within 7 days of receipt of the copy of the Institute grant.
MAH is obliged, at the request of the department
promptly submit data demonstrating that the risk-benefit ratio
medicine remains favorable.

(2) After the issue of the marketing MAH
notify the Institute or the Veterinary Institute data
actual placing of the medicinal product by pack size and type of packaging on the market in the Czech Republic
, not later than two months after his actual
placing on the market; in the same way also notify the Institute or the Veterinary Institute
least 2 months before the interruption or termination
marketing of the medicinal product on the market in the Czech Republic, including the reasons for such suspension or termination
. In exceptional circumstances you can make such notification
latest simultaneously with the interruption or termination of marketing
medicinal product on the market in the Czech Republic. If the renewal
placing the medicinal product on the market, the marketing authorization holder
obliged to report this fact immediately to the Institute or the Veterinary Institute
. At the request of the Institute or the Veterinary Institute, the holder of the marketing authorization
Institute or the Veterinary Institute data on the volumes of supplies
medicinal product and data relating to the volume
prescription medicine that is available.

(3) The marketing authorization holder is also obliged

A) ensure that the properties of the authorized medicinal product and
current documentation to him, including the SPC,
leaflet, labeling and documentation related to
its classification for the dispensing, match current data and documentation
on the basis of which the decision on registration, as
subsequent amendments; It is also obliged to keep records relating to the supply of medicinal products in the distribution
or pharmacies, using the codes assigned
Institute or the Veterinary Institute and in the supply
homeopathic products authorized by simplified registration procedure and their registration
radiopharmaceuticals way that allows their
traceability,


B) be available for each batch of medicinal product, proof of quality controls
medicinal product made in accordance with
dossier,

C) carry out in case of a risk to the health of treated persons or animals
all available measures to redress and to limit the adverse effects
authorized medicinal product at the lowest possible level
; such measures shall notify the Institute or the Veterinary Institute;
If it finds MAH quality defect
human medicine or if such a defect is detected and reported to him
Institute, the marketing authorization holder, if he does not order the Institute
other measures, implement measures to ensure that a replacement
medicinal product for the patient to any pharmacy for medicine
without such quality defects and the absence of such medication available
or if it is not possible to provide such an exchange, to ensure full withdrawal
medicinal product from the market, and its removal under § 88 and 89

D) provide upon request of the Institute or the Veterinary Institute
necessary cooperation, including providing samples to an authorized medicinal product
for the purpose of laboratory testing, reference substances in a quantity corresponding to the number
controlled batches and the possible need for repeated
inspection and present substance in an amount sufficient to perform
inspections to determine the presence of residues of veterinary medicinal product
and provide necessary assistance in the implementation
analytical method for detecting residues of veterinary medicines in
national reference laboratory designated by legislation ^ 50)

E) immediately inform the Institute or the Veterinary Institute, the data on changes
necessary to ensure cooperation of the Institute or the Veterinary Institute
MAH; These changes are not considered changes
registration

F) to ensure the establishment and maintenance of a system guaranteeing
records of each promotional sample of a medicinal product, its traceability and compliance
storage conditions, including transport in accordance with the summary of
product

G) in the case of human medicine

First establish and operate a publicly accessible specialist information service on
medicinal products for which marketing authorization holder, and
address and any change of address of the service, to inform the Institute,
publicly accessible professional information service shall not be used for advertising ^ 51)
information provided through it shall be in accordance with
SPC, part of the information provided
via a publicly accessible specialist information services are also
current information about whether or not the medicine
product is made available on the market in the Czech Republic

Second provide qualified sales representatives with the nature
medicinal product, to ensure the transmission of information obtained from sales representatives
visited persons on the use of medicinal
promoted products, especially information about any adverse reactions and
verify whether the business agents carry out their duties under a special legal regulation
51)

Third ensure that after placing the medicinal product on the market a medicinal product for
needs of patients in the Czech Republic, the supply of adequate quantity and
intervals; implementing regulation provides
way to meet the needs of patients in relation to the amount and timing intervals
medicinal supplies,

H) submit to the Institute or Veterinary Institute after legal force
holders or after making such changes, which resulted
change the appearance of the product or its packaging before putting the product into circulation
1 sample pack preparation;
in justified cases, the competent institution waive this requirement,

I) immediately notify the Institute or the Veterinary Institute
suspicion of occurrence of defects in the quality of the medicinal product.

(4) MAH, in the case of human medicine
shall immediately notify the Department and Member States concerned
any action taken by him to suspend the marketing of a medicinal product on the market
in the Czech Republic, to withdraw a medicinal product from the market in the Czech Republic
asked for cancellation of registration or asked for revalidation

Registration, together with the reasons for such action. This announcement
holder of the marketing authorization shall take even if the measures taken in
third country and establish if on any of the grounds listed in § 34 paragraph
. 4 or § 90. 3rd

(5) The marketing authorization holder shall notify the Agency
measures referred to in paragraph 4 if they are based on any of the grounds listed in § 34 paragraph
. 4 or § 90. 3rd

(6) In the event that the marketing authorization holder authorizes another person
to represent him in matters governed by this Act, shall notify this fact
Institute or the Veterinary Institute.

(7) marketing authorization holder responsible for damage caused in
due to the effects of a medicinal product not listed in the summary of
preparation, this responsibility can not be relieved;
for damage caused due to the effects of the medicinal product in the summary of product listed matches
MAH only
if it is proven that the emergence of such damage caused.

§ 34

Extension, refusal, suspension and cancellation of registration

(1) The authorization may be renewed after five years on the basis
reassessment of the risk-benefit
Institute or the Veterinary Institute. The extension of the marketing authorization holder may request
Holder Institute or Veterinary Institute
least nine months before the expiration of the marketing authorization. If it is a human
medicine, provide MAH
Institute together with the request or at the latest nine months before the expiration of the current registration
comprehensive documentation relating to the quality, safety and efficacy
including evaluation of data contained in reports of suspected adverse reactions
and regularly updated reports on safety
submitted in accordance with the fifth head of this Act, as well as information
about any changes introduced since the marketing authorization. If it is a
veterinary medicine Veterinary Institute provide a comprehensive list
all data and documentation submitted with respect to the quality, efficacy and safety
veterinary medicinal product together with an application for authorization or subsequently
within changes in registration.
Request for extension of validity of the authorization must contain data about the applicant as well as data
specifying the subject of the application and its justification. Once the validity of the registration
extended once under this Act shall be valid for an unlimited period
. In the case of human medicine, Institute
based on grounds relating to pharmacovigilance, including exposure of an insufficient number of patients
concerned medicinal product, may decide to re
renewal of the authorization for a further five years; in the case of
veterinary medicine Veterinary Institute may decide only about one meter
renewal of the authorization for a further 5 years, on
justified grounds relating to pharmacovigilance.
Provisions of the sixth and seventh sentence is without prejudice to cancel or suspend the registration
reasons set out in paragraph 4 or 5. Implementing legislation
provides a range of data and documentation submitted with the application for renewal of the authorization
.

(2) The procedure for renewal of the authorization is subject to the provisions of the registration procedure
analogy. The Institute or the Veterinary Institute
decide on such requests within 90 days of the submission of a complete application.
If the application for renewal of registration
Institute or Veterinary Institute within the period referred to in paragraph 1 has been delivered, is considered a medicine
those registered until the day when the decision on the application for renewal of the authorization
.

(3) If the labeling of a medicinal product or package
information does not correspond to the provisions of this Act or in accordance with
particulars listed in the summary of product or in its proposal
Institute or Veterinary Institute reject the application for registration or a change
registration or disagreement with the change according to § 35 para. 5th

(4) The Institute or the Veterinary Institute shall amend, suspend or revoke registration
medicine if

A) the medicinal product is harmful

B) a medicinal product lacks therapeutic efficacy,

C) the risk-benefit ratio is not a medicinal product

Favorable or when using the veterinary medicinal product
accordance with the terms of its registration is not risk-benefit ratio
favorable

D) the veterinary medicinal product has no therapeutic efficacy referred to in point b)
in the species for which it is intended

E) qualitative and quantitative composition is not
documentation submitted as part of the registration procedure and within subsequent changes
registration

F) the withdrawal period of a veterinary medicinal product is not sufficient to
order to ensure that food derived from animals which have been
veterinary medicinal product has been administered does not contain substances that could
pose a risk to health consumer

G) the veterinary medicinal product is offered for the use of which is prohibited or restricted
special legislation 18)

H) veterinary immunological product disrupts veterinary
measures with regard to the control or eradication of animal diseases,

I) data submitted with the application for registration is incorrect or not
changed according to § 33 para. 1 in accordance with § 35

J) were not submitted evidence of checks in accordance with § 64 point. u)

K) was not complied with in accordance with § 31a, § 32 par. 3, § 32 para. 4
point. c) or § 32a

L) the Institute or Veterinary Institute has not been disclosed information pursuant to § 33 paragraph
. 1 or § 33 par. 3 point. c) or

M) manufacture medicinal product not in compliance with the data provided
according to § 26 par. 5 point. d) or checks are not carried
control methods specified in their description according to § 26 par. 5 point.
H).

(5) The Institute or the Veterinary Institute shall suspend or revoke registration for
medicinal products or for all medicinal products that
manufacturer if the manufacturer fails to comply with the conditions documented in accordance with § 63 para. 1 and
obligation to report changes.

(6) The suspension of a marketing authorization in accordance with paragraphs 4 or 5 apply
Institute or the Veterinary Institute in cases where the information obtained
incomplete or such shortcomings are identified which are removable
nature. Cancellation of registration of a medicinal product by
paragraphs 4 or 5 apply Institute or Veterinary Institute
in those cases where the information is incomplete or are detected
shortcomings that are not removable nature.
Institute or the Veterinary Institute in the decision to suspend the marketing authorization
establishes the rights and obligations of the holder of the marketing authorization for the duration of the suspension
registration. After removing the reasons that led to the suspension
registration, the Institute or the Veterinary Institute decides to terminate
suspension of registration. If this does not eliminate the reasons that led to the suspension
registration within the deadline or within 3
years from the date of the decision to suspend the registration, if
deadline for their removal has not been established, or decides Institute
Veterinary Institute to cancel the registration of a medicinal product.
Appeal against the decision to suspend the marketing authorization has
suspensive effect.

(7) Registration of medicine expires upon the death of the holder of
registration, if a natural person or dissolution of the holder of the registration
, in the case of a legal person, if they disappeared without | || legal successor.

(8) A person who was the holder of the marketing authorization is required
after the entry into force of the decision revoking the registration or when the registration
ceased its expiry, immediately download
medicine from circulation. The manner of withdrawal of the medicinal product and the time
necessary to implement this withdrawal is obliged to inform the Institute or the Veterinary Institute
proceedings for cancellation of registration and if the registration expires
its expiry later than 15 days before
this extinction. In case of threat to human or animal health due
the swift withdrawal of a medicinal product from the market decides
Institute or the Veterinary Institute for gradual withdrawal of a medicinal product from circulation.
In this case, the person who was the holder of the marketing authorization, for the presence
medicinal product on the market continues obligations as
would MAH. If there is a cessation
MAH and there is no legal successor,
shall withdraw from circulation the Institute or the Veterinary Institute.


§ 34a

(1) The marketing authorization expires, if within 3 years from the date
date of coming into force is not a medicinal product on the market in the Czech Republic
; regarding generic medicine, the period begins to run from the date on which
period ends during which must be put on the market according to § 27 para. 1st

(2) If an authorized medicinal product placed on the market in the Czech Republic
not for 3 consecutive years of presence in the market
amount of at least one package of this product, if it is a human
medicine, or in an amount of at least one variant of
medicine, in the case of a veterinary medicinal product shall cease
decision on registration of the medicinal product shall, where
It begins on the first day of the year following the year in
which the medicinal product was launched in the Czech Republic.

(3) The Institute or the Veterinary Institute in exceptional circumstances and taking
protection of public health or animal health or because
existence of rights of third parties may, on a justified request of
Holder submitted soon 6 months later
3 months before the expiry of the period referred to in paragraph 1 or 2 or ex officio
decide to grant exceptions so that this provision applies to the
Holder does not apply.

(4) If the medicinal product on the market in the Czech Republic or
renewed its presence in this market after the filing of the application
exception, the marketing authorization holder shall immediately notify
Institute or Veterinary Institute this fact with the name
medicinal product, its code, batch, distributor, data
putting it on the market or restore its market presence and number of packages.

(5) The decision on the exemption issue, the Institute or the Veterinary Institute
before the expiry of the period referred to in paragraph 1 or 2. A decision on the exemption
a justification or information about the expiry of the decision to publish the registration
the Institute or the Veterinary Institute in its information
resource.

(6) If the medicinal product on the market or present on the market or in
six months after the termination of the reasons for the exemption, the competent institution of
ex officio, decide to revoke the exemption decision.

§ 35
Variations


(1) The marketing authorization holder is obliged every variation
submit to the Institute or the Veterinary Institute for approval, or it
announce or report. When making changes to registration, the
directly applicable European Union to assess the changes in registrations
human and veterinary medicinal products ^ 90). Under the procedures
assessing changes in human and veterinary medicines
by the directly applicable European Union
communication between the marketing authorization holder, the competent institution and the competent authorities of the Member States
generally takes place electronically through
the systems in place for these procedures in the European Union.

(2) The medicinal product corresponding to the data and documentation before making changes
registration can be, unless the decision to change the registration
stated otherwise, continue to be marketed for a maximum period of 180 days from the approval
changes. Distribute, publish, in the case of reserved
medicinal products sold, and used in the provision of health care or veterinary care
is a medicinal product may be further
over its useful life.

(3) In case of changes in the Annexes to the directly applicable European Union
laying down the procedures for the establishment of residue limits of pharmacologically
active substances in foodstuffs of animal origin ^ 5) forthwith request
MAH veterinary medicinal product
change of registration pursuant to paragraph 1, so that registration
veterinary medicinal product in accordance with the requirements of that regulation.
If so MAH fails, the Veterinary Institute
within 60 days of the publication of the relevant amendments to the annexes
directly applicable EU regulations laying down the procedures for determining the levels
residues of pharmacologically active substances in foodstuffs of animal | || origin ^ 5) in the Official Journal of the European Union orders such holder
holder taking provisional urgent

Security restrictions.

(4) If authorized to change the classification of a medicinal product
on the basis of significant preclinical tests or clinical
assessment must take into account the results of the Institute of those tests or trials when examining
request for changing the classification of another medicinal
product containing the same substance that is submitted by another
registrant or marketing authorization holder for a period of one year from
initial change was authorized registration.

(5) Any proposed changes to the labeling of a medicinal product
or changes in the package leaflet unrelated to the summary of product
must be notified by a request for variation of the Institute or Veterinary Institute
. If the Institute or Veterinary Institute
prompted by a proposed change within 90 days of receipt of the notice to modify or supplement the application or
has disagreed with the proposed amendment, the applicant
can make this change. Supplement the application on the basis of calls made by the applicant
only once. If, within 30 days of receipt of the invitation
Institute or the Veterinary Institute does not receive a response or receives a response that is not
compliant within the next 30 days shall reject the application.
If the Institute or Veterinary Institute does not do so, it shall be notified change for
approved. The application must contain data about the applicant as well as data
specifying the purpose of the request and its justification and draft of the packaging
medicine or leaflet.
For marketing the medicinal product on the market in the form of appropriate documentation before making
changes to the provisions of subsection 2 accordingly.

§ 36

Transfer registration

(1) The marketing authorization holder may submit a transfer request
registration to another person or entity. The request must include
data about the applicant as well as data specifying the subject of the application and its
reasoning and proposed date on which the transfer is to be effected
registration. The application must be accompanied by the consent of the person to whom
registration to be transferred. Application may be made only in relation to one
Holder. The application must be accompanied by proof of payment
administrative fee under special legal regulation 41) or
proof for reimbursement under § 112 if requested in advance.
Implementing legal regulation stipulates the scope of data and documentation presented.

(2) The Institute or the Veterinary Institute shall, within 30 days of receipt of the request
decision to allow or reject it.

(3) The decision on the transfer of registration shall specify the date on which the transfer
registration will take place. Application may be rejected only if

A) the information and documentation submitted with the request, even after the invitation to complete
incomplete or otherwise defective, or

B) the person to whom the registration is transferred, not resident or established
^ 21) in the territory of a Member State.

(4) New MAH enter fully into the rights and obligations of the previous
MAH.
Time limits laid down by the previous holder of the marketing authorization is not a transfer
registration affected. Medicine corresponding data and documentation
prior to the transfer of registration, unless the decision on registration of transfer
stated otherwise, may continue to be marketed for a maximum period
180 days from the date of registration of transfer. Distribute, publish, in case
selected medicinal products sold and used in the provision
health services or health care is such a medicine
possible for a maximum period of application.

The designation of the medicinal product and the package leaflet

§ 37

(1) Data presented on the outer and inner packaging of a medicinal product, with the exception
homeopathic products authorized under § 28, must
accordance with the approved summary of product characteristics.
Implementing legal regulation stipulates the scope of data that are placed on the outer and inner packaging
medicine, presented data on small and special
types of packaging, including the packaging of medicinal products containing radionuclides, and conditions put forth
data for identification of the medicinal product
European Article Number (EAN), which is used for electronic
processing, and the possible introduction of classification specified for medicinal

Product. Data shown on the packaging of a medicinal product must be easily
legible, comprehensible and indelible. Of the medicinal product
not permitted any elements of advertising. Name
human medicine must be given on the outer package also
Braille lettering, unless stipulated otherwise in the marketing authorization.

(2) In the case of medicinal products authorized in the European Union, for
issued a marketing authorization under directly applicable EU regulations
^ 24), the Institute or the Veterinary Institute may authorize or require
that the outer packaging bear additional information concerning
distribution, marketing or other necessary measures.
Implementing legal regulation stipulates the scope and manner of reporting these data.

(3) Each medicine must be equipped with a leaflet
except in cases where all the information leaflet
listed on the packaging of a medicinal product
way stipulated by law. MAH
a medicinal product shall ensure that the information leaflet
human medicine were at the request of blind or partially-sighted or
their organizations in accessible format for blind and visually impaired.

(4) The package leaflet must be with the exception of homeopathic products
registered according to § 28 prepared in accordance with the summary of product
. The package leaflet must be clearly legible and understandable
for the patient, if a human medicinal product or for a person using
veterinary medicine. In the case of medicinal products must
leaflet reflect the results of consultations with
groups of patients receiving medicinal product is intended to ensure
it is legible and understandable. As a result of consultations under the preceding sentence
You can also use the results of consultations carried out within the European Union
. Leaflet may not contain any elements of advertising
character.

(5) Details of the medicinal product and the package leaflet must be
in the Czech language; if they are listed in multiple languages, they must be identical
contents. The scope of data and breakdowns leaflet provides
implementing legislation.

(6) homeopathic product, the packaging and the package leaflet
marked with the words "homeopathic medicinal product ', if it is a human
homeopathic medicine, or" homeopathic veterinary medicinal product
"goes if a veterinary homeopathic product. On the packaging
homeopathic product and the package leaflet must be given only
information provided in this Act and the implementing legislation for
leaflet.

§ 38

When the medicinal product is intended to be delivered directly to the patient or
if they are serious problems with the availability of medicine, the Institute or Veterinary Institute
Holder allow not been
labeling and the leaflet contain certain information;
Competent institution may also be wholly or partly allow
markings on the package leaflet were in the Czech language.
Implementing legal regulation stipulates the cases where you can specify the label other than
Czech language.

§ 39

Classification of human medicinal products for dispensing and sale of selected pharmaceuticals


(1) the registration process of the Constitution provides that the medicine
shall be issued only on prescription or on medical prescription
restrictions or whether the medicine may be dispensed without a prescription or without medical
restricted prescription.

(2) The medicinal product shall be issued only on prescription, if

A), even when used correctly represent direct or indirect
dangers when used without medical supervision,

B) it is often a very wide extent used incorrectly, and as a result
that may pose a direct or indirect threat to human health,

C) contain substances or preparations thereof, the activity or
side effects require further investigation, or

D) is intended for parenteral administration.

(3) In deciding whether a medicinal product should be classified as a medicinal product
whose prescription-only on prescription
Department assess whether the medicine


A) contains a substance classified as a narcotic or psychotropic or a precursor
^ 40) in an amount which does not issue
without medical prescription

B) improper use may pose a substantial risk of abuse
drugs lead to addiction or be misused for illegal purposes,

C) contains a substance which, on the basis that it is new or based on
their properties, could be a preventative measure is considered
belonging to the group as defined in b).

(4) in Category dispensing of medicines only
prescription may be the decision of the Institute determined that
medicinal product shall be issued only to restricted medical prescription.
This can only be prescribed by a doctor with specialized qualifications or doctor
competence under the supervision of a doctor on the basis
it issued a written authorization. Alternatively, it may be determined by restriction
amount of medicine emitted by a single patient in a given period
. When deciding on the inclusion in this category Department will assess whether a medicine


A) for its pharmacological properties or because it is new, or
interests of public health, is reserved for treatments which can be carried
only medical facility inpatient care

B) is used to treat conditions which must be diagnosed in
medical facility or inpatient care in health facilities
adequate diagnostic facilities, although administration and follow
monitoring of such facilities may not be done ,

C) is intended for patients in ambulatory care, but its use may
cause very serious side effects or may pose a significant risk
abuse, which requires a prescription by exposure requirements
doctor with specialized qualifications and
special supervision throughout the treatment.

(5) The inclusion in the category of dispensing medicine without a medical prescription may be
decision of the Department determined that the medicine is
issued with restriction, may create hazards to human health, which can be avoided
by imposing certain restrictions on such an issue, or
for its proper use is required prior consultation with a specialist
pharmacist. This medicine may be issued only to the person who is
intended that the operator authorized to dispense
is required to keep documentation on his release. Details expert assessment of the conditions for the use of the medicine
carried out by a pharmacist and further restrictions may lay
Department of the holder; for such restriction
considered in particular the determination of the age limit natural person who requests such
dispensing medicine, dose determination for each
administration, reducing the amount of medicine dispensed one
patient during a specified period. The scope and method of keeping records on
dispensing medicine dispensed without a prescription
limited in the implementing legislation.

(6) The Institute may waive individual evaluations of the product
according to the criteria set out in paragraphs 2 to 5 with respect to

A) the maximum single dose, the maximum daily dose, the strength, the pharmaceutical
form, certain types of packaging or

B) other circumstances of its use.

(7) During the procedure for renewal of the registration
or if new facts known to the Institute, the Institute will examine using
decision-making criteria in paragraphs 2-5 classification for the dispensing
medicine that takes account of the fact that
medicinal products with the same strength, the same pack size and
containing the same active ingredient were classified in the same category of expenditure.
If concludes that the method of dispensing needs to be changed in case
renewal changed the method of dispensing a decision on renewing
valid registration, or initiate proceedings to change the registration on his own initiative
. MAH is required in these proceedings
submit proposals for amendments to Constitution in the summary of product characteristics,
leaflet and labeling on the package.

(8) In the case of dispensing without prescription Department decides whether
medicinal product may be classified as reserved medicinal products with regard
to ensure safety. The implementing legal regulation stipulates individual

Class of medicines that can be classified as reserved
medicinal products and their characteristics.

§ 40

Classification of veterinary medicinal products for dispensing and use

(1) In the registration procedure the Veterinary Institute shall determine whether
authorized medicinal product must be dispensed only on medical prescription
or whether it is a medicinal product not subject to medical prescription.

(2) Veterinary Institute restrict the decision Medicinal product
prescription only if

A) contains a substance classified as a narcotic or psychotropic or a precursor
^ 40) in the amount neumožňujícím dispensing without prescription

B) the use of the medicine in the provision of veterinary care
subject to restrictions under a special legal regulation 18)
or other European Union legislation,

C) is a medicinal product, in which case it must be
veterinary doctor who prescribes medicine, uses or publishes,
taken special precautions to reduce the risks for

First target species,

Second persons medicinal product administered to animals,

Third environment,

D) The drug is indicated for the treatment of pathological conditions requiring
accurate medical diagnosis, or in the case of medicine
whose use can cause effects that may adversely affect
subsequent diagnostic or therapeutic acts

E) contains an active substance that is in medicinal products registered
less than 5 years, or

F) it is a medicine that is intended for animals from which they are derived
animal products intended for human consumption;
Veterinary Institute may, as part of the marketing authorization to provide that medicine can
issue without a prescription, if the administration of
does not require special skills or abilities and the product does not represent a direct or indirect danger to


First Animals, which is administered

Second people who use it,

Third consumers of animal products derived from animals treated with such composition and


Fourth Environment.

Implementing regulation provides, in accordance with the conditions set out in point
f) cases where the marketing authorization stipulates that
medicinal product intended for animals, which are obtained from animal products for food
a person may be issued without a prescription, including
determine how their assessments.

(3) In the case of medicines for which there is no limitation
prescription, the Veterinary Institute forth about whether
be a medicine with a view to ensuring the safety rank among
reserved medicinal products. The implementing legal regulation stipulates individual
group of medicines that can be classified as reserved
medicinal products and their characteristics.

(4) Veterinary Institute when granting authorization with regard to the risks associated with the use
relevant medicinal product further decided in the context of
Holder about possible limitations on the persons who are authorized to use
veterinary medicines and
classification of veterinary medicinal products for veterinary use
doctor.

(5) Veterinary Institute restrict the marketing authorization for the medicinal product
whose prescription for prescription use only
veterinarian regarding medicinal product for which the

A) the risk-benefit ratio is such that before its use or
then it is necessary to adopt special professional measures to limit the risks associated with the use
medicinal product

B) due to improper use or incorrect medical diagnosis
increased risk of serious side effects or adverse effects
which are associated with the use of a veterinary medicinal product
occur in humans

C) for its use required special professional competence or whose
safe use requires specialized hardware or

D) increased the risk of possible abuse in the provision of veterinary care
with regard to violation of the veterinary authorities

In the prevention and eradication of animal diseases, with regard to the abuse
with the aim of increasing animal performance or other forms of abuse.

Mutual recognition of authorizations Member States

§ 41

(1) In order to grant a marketing authorization in several Member States
, one of which is the Czech Republic, the applicant shall submit a
Institute or the Veterinary Institute and the competent authorities of those Member States
request for registration based on an identical
dossier. The registration dossier contains the data and documents under §
26th applicant shall request the competent authority of a Member State
to act as the authority of the reference Member State and that
prepare an assessment report on the medicinal product referred to in paragraph 2 or 3
; in the case of veterinary medicinal products may contain
assessment report and evaluation for the purpose of extending the period of 10 years pursuant to § 27 paragraph
. 2 point. b) or the period referred to in § 27 para. 6 point. b).
If requested by the registrant to the Reference Member State was Czech Republic
, asks for the Institute or the Veterinary Institute. Under the procedures
mutual recognition of authorizations between Member States communication
registrant, to the competent institution and the competent authorities of the Member States
generally takes place electronically through a system
established for these procedures in the European Union. The registrant also
competent institution in the process of mutual recognition of authorizations
Member States shall act in accordance with guidelines issued by the group
representatives of the competent authorities of the Member States coordinating this registration process (hereinafter
"coordination group").

(2) If a medicinal product at the time of submission of the registration
already registered in another Member State, the Institute or the Veterinary Institute
recognize the marketing authorization granted by the competent authority of the Member State of reference
. To this end, the marketing authorization holder
competent authority of the reference Member State either to prepare a report on the evaluation
medicinal product or, if necessary, to update
existing assessment report. If the reference Member State
Czech Republic and the Institute or the Veterinary Institute makes acts as the competent authority
reference Member State, the competent institution
prepare or update the assessment report of the medicinal product within 90 days of receipt of a complete
request to act as the authority of the reference Member State.
Report on the evaluation of medicinal product together with the approved summary
of product characteristics, labeling and package leaflet
Institute or the Veterinary Institute in such a case to the competent authorities
Member States in which the application was made under paragraph 1, and
registrant electronically.

(3) In the event that the product was not at the time the application is submitted pursuant to paragraph 1
registered in a Member State shall ask the applicant for registration
Institute or Veterinary Institute, where the reference Member State
Czech Republic to prepare a draft assessment report
medicinal product, a draft summary of product characteristics, labeling proposals on packaging
a draft leaflet. The Institute or the Veterinary Institute
prepare these draft documents within 120 days of receiving a complete application for registration
and send to the competent authorities of the Member States in which
application was submitted pursuant to paragraph 1, and registrants
electronic.

(4) Within 90 days of receipt of the assessment report of the medicinal product
summary of product characteristics, labeling and package leaflet
referred to in paragraphs 2 and 3, unless the Czech Republic reference
Member State, the Institute or the Veterinary Institute to provide these documents electronically
competent authority of the Member State of reference
standpoint. If the Member State of reference
Czech Republic, the Institute or the Veterinary Institute shall record the approvals of
all competent authorities of the Member States in which the application was filed
, close the procedure and inform the applicant.
Institute or the Veterinary Institute where he was submitted pursuant to paragraph 1
issued within 30 days of reaching consensus competent authorities of the Member States
marketing authorization in accordance with the approved assessment report

Medicine, summary of product characteristics, labeling and package leaflet
. This applies even if the application is submitted pursuant to paragraph 2.


(5) If the period of 90 days can Institute or the Veterinary Institute
issue a favorable opinion pursuant to paragraph 4 of the report on the evaluation of medicinal
product summary of product characteristics, labeling and package information by
paragraphs 2 and 3, unless the Czech Republic
reference Member State, on grounds of a potential serious risk to public health,
case of a human medicinal product or a serious risk to health
humans, animals or the environment, in the case of a veterinary medicinal product
shall electronically detailed reasons for its position
competent authority of the Member State of reference
competent authorities of the Member States, which the application was submitted pursuant to paragraph 1, and the applicant
. Questions on the disagreement shall be forthwith referred to the coordination group
. Representative of the Institute or the Veterinary Institute within
coordination group aims to reach agreement on measures to be taken
to eliminate disagreements. If within 60 days of notification
issues on which disagreement, the competent authorities of the Member States
agreement, the Institute or the Veterinary Institute in accordance with paragraph 4.


(6) If the competent authorities of the Member States do not reach agreement within 60 days
is immediately informed agency with regard to the application of review procedures
according to EU regulations ^ 53).
Institute or the Veterinary Institute, if the Czech Republic Reference State
submit questions for which the competent authorities of the Member States
could not reach agreement and the reasons for their disagreement with the reasons
Agency. Copy to the applicant who shall forthwith forward to the Agency
copy of the dossier referred to in paragraph 1. Although an agreement has not been reached
first sentence, the Institute or the Veterinary Institute where
approved the assessment report, the summary of product , labeling and packaging
leaflet by the competent authority
reference Member State, at the request of the medicinal product
before the completion of the review process.

(7) If the Veterinary Institute applies reasons pursuant to § 34 para. 4 point.
H) the provisions of paragraphs 1 to 6 shall not apply.

§ 42

(1) If, in line with European Union law submitted
2 or more applications for marketing authorization of a medicinal product and
competent authorities of the Member States have adopted divergent decisions concerning the authorization
medicinal product or its suspension or
compared to repeal the decision of the Institute or the veterinary Institute, the Institute or the veterinary Institute
, registrant or MAH
may refer the matter to the Committee for human medicinal products or the Committee for veterinary medicinal
preparations for application the review process. On
promote harmonization of authorizations for medicinal products authorized in the European Union
, in the case of veterinary medicinal products to support
rules on the use of medicinal products in veterinary care
, transmit Institute or Veterinary Institute every year || | coordination group a list of medicinal products for which they should be drawn
harmonized summary of product characteristics. Department
agreement with the Agency and taking into account the views of the parties concerned may
non-harmonized marketing authorizations of these medicines
to the Committee for Medicinal Products for application review process.

(2) The Institute or the Veterinary Institute, the applicant or holder
marketing authorization in specific cases that relate to the interests of the European Union
refers the matter to the Committee for Medicinal Products
or the Committee for Veterinary Medicines for application of the procedure
review before any decision is reached on a request for
registration or to suspend or revoke registration or any other change
registration, which seemed to be necessary.
If the submission is based on the evaluation of pharmacovigilance data registered
human medicine, refer the matter to the Pharmacovigilance Committee
risk assessment of pharmaceuticals. The Institute or the Veterinary Institute clearly define

Question submitted to the committee for review and
inform the applicant for or holder of the marketing authorization.
Institute or the Veterinary Institute, the registrant or the holder of the registration
transmit to the committee all available information
relating to the matter. If any of the conditions listed in §
93i paragraph. 1 and 2, the Institute shall proceed in accordance with § 93i.

(3) Following the Commission issued a referral
Institute or the Veterinary Institute within 30 days of notification of the decision
grant or revoke the registration or makes changes as necessary to
comply with Commission Decision and they shall refer to a
inform the Commission and the Agency.

(4) The holder of the authorization granted by the Institute or the Veterinary Institute
under the provisions of paragraphs 1 to 3 or § 41 if the application for variation
submit this application and all relevant authorities
Member States the product has already been registered.
This does not apply if an agency has restricted, in the case of a group of medicines
or therapeutic class, the review procedure only on certain
specific parts of the authorization and also for medicine has not been
procedure is applied in accordance with § 41 and this section .

(5) If the Veterinary Institute considers that the protection of public health, animal health or
environmental change is necessary
authorization granted in accordance with the provisions of paragraphs 1 to 4 or § 41 || | or that it is necessary to suspend or revoke a registration, it shall notify this matter
Agency for the application review process.

(6) Without prejudice to the provisions of paragraph 2, the Veterinary Institute in
exceptional cases to protect public health
animals or for the protection of the environment is important to undertake urgent measures
until adoption of the final decision to suspend distribution
dispensing, sale vendor of selected medicinal products or
use of the medicinal product in the Czech Republic.
Later than the following working day of the Veterinary Institute shall inform the Commission and the competent authorities of other Member States
reasons for its action.

(7) The provisions of paragraphs 4-6 shall apply to medicinal products
registered in accordance with European Union regulations, 54) likewise. On
homeopathic products registered pursuant to § 28 or 29 shall not apply
paragraphs 1-6, § 41 paragraph. 6 and no referral procedure.

(8) Without prejudice to the provisions of paragraph 2, the Institute
pending a final decision in exceptional cases, in order to protect
public health, suspend the marketing authorization and prohibit its use
. By the next working day
Department informs the Commission, the Agency and the competent authorities of other Member States
reasons for such a measure.

§ 43

Registration of medicinal products under the centralized procedure of the European Union

(1) The Institute or the Veterinary Institute on request
Agency or other competent authority shall ensure that the European Union under directly applicable EU regulations
^ 24)

A) test the medicinal product, its starting materials and, if need
, its intermediate products or other components to verify that
control methods employed by the manufacturer and described in the application dossier
registration are sufficient; it performs the role of the official laboratory for
Medicines Control by the directly applicable European Union
^ 24)

B) the transmission of information showing that the manufacturer of a medicinal product or
importer from a third country is able to manufacture the medicine
or carry out the necessary control tests in accordance with directly applicable EU regulations
^ 24) in accordance data and documents supplied by
directly applicable EU-24)

C) control of the marketing authorization holder, the manufacturer or importer from
third country, including individual manufacturing sites pursuant to a directly applicable regulation
EU-24)

D) evaluation of the draft decision obtained by directly applicable EU regulations
^ 24), and when exercised their comments
written submission to the Commission within the time limit set by the directly applicable regulation
EU-24).

(2) Information on any prohibition or restriction imposed by the competent

Authorities of any country in which the medicinal product is marketed, and
any other new information which might influence the evaluation
benefits and risks of the medicinal product set
directly applicable EU regulation ^ 24) informs the holder of the authorization shall forthwith
Institute or Veterinary Institute.

(3) The Institute or the Veterinary Institute registers and publishes medicines
registered by the directly applicable EU-24) and
immediately grant them a code according to § 32 par. 5, which shall notify the holder of the relevant
Holder and publish it in its information
resource. Before assigning the code can not begin
distribution of the medicinal product.

(4) The authorities of the Czech Republic, which makes acts by directly applicable EU regulations
^ 24), including the suspension of the use of the medicinal product
, the Institute and the Veterinary Institute.

(5) The Institute or the Veterinary Institute shall ensure that all suspected serious adverse reactions
medicinal products authorized by the directly applicable regulation
EU-24), which occurred on the territory of the Czech Republic, and
he has been reported, recorded and reported to the Agency
and the holder of the marketing authorization of a medicinal product
in accordance with applicable regulations of the EU-24), and it
later than 15 days from the receipt of the information.

(6) The Institute or the Veterinary Institute is working to develop guidelines and
participate in the establishment and operation of an information network for the rapid transfer
information between the competent authorities of the European Union under directly applicable regulation
EU-24) ; evaluate the information received and provides
in the Czech Republic to take adequate measures.

§ 44

Takeover registration from another Member State

(1) Acceptance of the registration of another Member State (hereinafter referred to as "takeover
registration") means the recognition of a marketing authorization for a medicinal product granted
in another Member State by decision of the Institute, with the legal consequences
registration taken are consistent with the legal consequences
marketing authorization pursuant to § 32, unless stated otherwise.

(2) Acceptance of the registration is possible only in exceptional situations needs
when there is no effective treatment for patients, including prophylaxis or determination
diagnosis, registered in the Czech Republic or by directly applicable EU regulations
^ 24) human medicine and not even in the Czech Republic
submitted an application for its registration and acceptance of registration
justified by the protection of public health, if

A) concerning the assumption authorization for a medicinal product authorized in
Member State in accordance with European Union law,

B) the medicinal product is used in the Czech Republic only for dispensing on
prescription

C) designation of the medicinal product and the package leaflet in Czech language
Institute may decide that this condition may not be satisfied
if it does not increase the risk to human health in the context of
with the use of the medicinal product.

(3) On receipt of the registration decides Department upon request.
Applicant on receipt of registration may be natural or legal person who is not
marketing authorization holder of the medicinal product in the Member State
or a person connected with him commercially. The application must contain data about the applicant
further details specifying the subject of the application and its justification.
Implementing legal regulation stipulates the scope of these data and relevant documentation
.

(4) The request made by the Institute on the basis of the opinion of the Ministry of Health
to the necessity of the medicinal product with a view to protecting public health
within 60 days of its receipt.
If requested by the applicant from the Department of receipt of registration
supplement the information or other documents, proceedings in the case. The Institute asks
authority of the Member State to provide a copy of the assessment report of the medicinal product
a valid marketing authorization for the medicinal product,
whose registration is to be taken, and shall request the opinion of the Ministry of Health
which this statement shall be issued within 30 days. If it takes
interrupt the proceedings for more than 180 days, the Department of proceedings.
The Institute shall be refused if, in the course of the procedure that


A) according to the Health Ministry is not about medicine
needed to protect public health

B) the conditions of paragraph 2 or

C) the applicant for registration takeover sufficiently substantiate
ability to meet the obligations under paragraph 9.

(5) Before deciding on the takeover Registration Department shall notify the holder
marketing authorization in the Member State where the medicinal product
authorized intention to make a takeover
authorization of the medicinal product.

(6) Acceptance of a marketing authorization, as well as the expiry
decision to take a picture Announces Institute
Commission, indicating the names and addresses of the holder of the receipt of registration
case of a legal person, or the name, surname and place of business
holder of the registration receipt, in case of a natural person
. Information on takeover Registration Department will publish its
information media. Any medicinal product which has been
decision to take a picture assign Institute code according to § 32 paragraph. For the fifth
medicine with a cover registration applies
summary of product whose registration was readmitted with a that it may not be
include details covered in the Czech Republic
protection under special legal regulations 55).

(7) The decision on adoption of marketing authorization may be
imposing conditions relating to the supply of medicine.

(8) Decisions on acceptance registration is valid for 5 years from the date of its
legal force and can, upon request, at the same time repeatedly
extended. Decisions on acceptance of registration shall be subject annually
reassessment of whether the conditions under which it was issued, shall remain in force
. In case the conditions for the receipt of registration
no longer met, Department decision to take the registration is canceled. Department changes
suspend or revoke the decision to take a picture of the reasons
specified in § 34 para. 4 or 5 similarly.

(9) The holder of a takeover registration is required

A) keep records of the origin of packaging and batch numbers of the imported
medicine for at least 5 years

B) to ensure the cessation of supply or marketing of the imported medicinal product
to the same extent as it happens for the medicinal product
in the relevant Member State when to stop dispensing or
marketing occurred due to a quality defect or reduced
safety or efficacy of the medicinal product or when there
deregistration in the Member State because of reduced efficacy or safety
,

C) by applying for a change in registration, changes in registration
concerned medicinal product in the Czech Republic so that the registration
complies with the conditions of registration in the Member State where the
these changes relate to his the efficacy and safety

D) when repackaging, re-labeling and any other adjustments
imported medicinal product to use only the services of manufacturers of medicinal products and their
any changes prior notification to the Institute

E) unless he holds a license to distribute medicinal products
ensure the distribution of a medicinal product from another Member State
through a person who is the holder of the permit

F) mark repackaged medicine; implementing regulation provides
way of marking

G) providing interoperability Institute according to § 33 par. 3 point. d) and e)
similarly

H) announce the commencement of distribution of a medicinal product from another Member State
holder of the marketing authorization for this medicine in
Member State concerned and give him, if the holder of the decision on registration
requested, this sample medicinal product in the form in
what is reported in the Czech Republic market

I) ensure pharmacovigilance primarily by collecting data on adverse reactions and
recorded adverse reactions to notify the holder of the
authorization in the Member State and the Constitution.

(10) the decision on acceptance of registration shall not affect the liability of the manufacturer
medicine and holder of the marketing authorization for the medicinal product
for damages caused by this medicine.

§ 45

Parallel import medicine


(1) Parallel importation means the distribution of a medicinal product from another Member State
to the Czech Republic, if this medicinal product
has been granted in the Czech Republic and in a Member State and
distribution is provided by the MAH
for the medicinal product in the Czech Republic or in conjunction with it. Make
parallel import of a medicinal product may be subject to permission for
parallel import medicinal product. For parallel import is not
distribution from another Member State to the Czech Republic, in the case of a medicinal product authorized
according to § 25 paragraph. 1 point. b).

(2) Parallel importation is only authorized for distribution authorization holder
medicines, and if

A) parallel imported medicinal product has been granted in
Member State and the registration was not canceled due
protection of public health,

B) parallel imported medicine will be distributed in the Czech Republic with
qualitatively and quantitatively identical composition in terms of
active substances and the same pharmaceutical form as a medicinal product, which
has been granted in Czech Republic (hereinafter the "reference product
parallel import ') and the registration was not canceled
order to protect public health and

C) parallel imported medicinal product has the same therapeutic effect as
reference product for parallel import, constitute
risk to public health, and is used under the terms of the marketing authorization
reference product for parallel import.

(3) If the requirements of this Act, the Institute or the Veterinary Institute
issue a permit for parallel import of medicinal product
request, stating the

A) identification data of the reference product for parallel import and
medicinal product authorized in the Member State which will be subject
parallel import, and relevant marketing authorization holders,

B) leaflet and a sample of a medicinal product in the form in which it is
marketed in a Member State

C) a sample of a medicinal product in the form of what is intended to be placed on
market in the Czech Republic, including a draft leaflet in Czech
language

D) a list of manufacturers involved in the repackaging, relabeling or other
manufacturing operations conducted in parallel imported medicinal
product and demonstrate the relevant manufacturing authorizations or evidence of compliance
GMP

E) any differences between the reference product for parallel import and parallel import
medicinal product if they are known by the applicant.

(4) An application for authorization of parallel imports of medicinal products
Institute or the Veterinary Institute shall decide within 45 days of its receipt
. If requested by the Institute or the Veterinary Institute, the applicant
supplement the information management is to supply the requested information
interrupts. If the suspension lasts more than 180 days, the Institute or the Veterinary Institute
proceedings on the request to stop.
Institute or the Veterinary Institute in cases where evidence is not sufficient to assess compliance
therapeutic effects, request information about registration conditions
parallel imported medicinal product from the competent authorities abroad.
In the event of such a request basis, the period of 45 days is extended to 90 days
. During the period from the request for documents from the relevant authorities abroad to
their service to the competent institution period of 90 days for processing applications for
parallel import of medicine is not running.

(5) Any medicinal product for which a permit has been granted
parallel import code given by the competent institution according to § 32 paragraph. 5th

(6) The marketing authorization holder of the reference product for parallel import
provide at the request of the department about the conditions
registration in the Member States, differences in registration
reference product for parallel import in the Czech Republic and Member States
including data on manufacturing sites, for the purpose of assessing applications for
parallel import of a medicinal product and after issuing a permit for parallel import
to monitor the properties of parallel imported
medicine.

(7) The holder of the authorization of parallel imports of medicinal products is obliged


A) proceed in accordance with § 44 para. 9 point. a) to d) similarly

B) mark repackaged medicine; implementing regulation provides
way of marking

C) providing interoperability Institute or Veterinary Institute
according to § 33 paragraph. 3 point. d) and e) similarly

D) notify the marketing authorization holder of the reference product for parallel import
in the Czech Republic that it intends to commence parallel import
medicine, and give him if it
holder of the authorization requested, sample parallel imported medicinal product
in the form in which it is placed in the Czech Republic market

E) ensure pharmacovigilance primarily by collecting data on adverse reactions and
recorded adverse reactions to notify the holder of the marketing authorization and
Institute or Veterinary Institute.

(8) The validity of an issued authorization of parallel imports of medicinal products is
five years and may be extended upon request for an additional period of 5 years, even
repeatedly. The proceedings on the extension of the parallel import authorization
paragraph 4 applies mutatis mutandis. In case of suspension or revocation
authorization of the reference product for parallel import in the Czech Republic
or parallel imported medicinal product in the Member State
Institute or Veterinary Institute will evaluate whether to suspend or revoke the registration
occurred as a result of findings unfavorable risk-benefit ratio
medicine.

(9) The Institute or the Veterinary Institute shall suspend or revoke a permit
parallel import in case the validity of parallel import
medicine poses a risk to public health, or fails to comply
If the holder of parallel import authorization of a medicinal
of the conditions stated in the permit, or violated in a serious way
obligations under this Act. Parallel import authorization
Institute or the Veterinary Institute suspends in cases where the information obtained
incomplete or such shortcomings are identified which are removable
nature. Parallel import authorization Institute or the Veterinary Institute
canceled in those cases where the information is complete or
are detected deficiencies that are not removable nature.
Institute or the Veterinary Institute shall revoke the parallel import of a medicinal product
at the request of the person to whom it was issued.

(10) and enabling the implementation of parallel imports of medicinal products
not affect the responsibility of the marketing authorization holder of the reference medicinal product
parallel import.

§ 46

Exemptions have licensed the Central Veterinary Authority

(1) Central Veterinary Authority may, upon receipt of a request
attending veterinarian exceptionally
decide to allow the use of a medicinal product that is not registered under this Act,
case of

A) immunological veterinary medicinal product

First in the event of a major animal disease or a disease communicable from animals to humans
or

Second when an animal imported from a third country, or where the third country
exported and is subject to specific binding health rules
; In such a case, the Central Veterinary Administration
allow the use of immunological veterinary medicinal product which is
registered in the third country in accordance with the relevant legislation
relevant third countries

B) other than immunological veterinary medicinal product whose use is
necessary in view of preventing animal suffering, which is to be administered and
for which you can not use another medicine under § 9. 1st || |
(2) In the case of implementation of protective and control measures in case
incidence of animal diseases and diseases transmissible from animals to humans may
Central Veterinary Authority may decide to permit use of the veterinary medicinal product
pursuant to paragraph 1. a) paragraph 1 on its own initiative.

(3) Before issuing a decision on the exemption under paragraphs 1 or 2 may
Central Veterinary Authority may request an opinion
Veterinary Institute. The decision on dispensation Central Veterinary Administration always provides


A) the amount of the medicine to be imported

B) a person who takes medicine,

C) the method of placing the medicinal product on the market,


D) the timing of imports of medicinal products and, possibly, its use

E) if it is necessary due to the nature of the medicinal product, method
taking the medicine.

(4) The exemption from registration under paragraph 1 or 2
published the following information:

A) the name of the product,

B) the active substance or substances contained in the medicinal product,

C) animal species and therapeutic or preventive indications for which the product
allowed to use

D) the restrictions for placing the medicinal product on the market, if it was determined
and

E) the timing of imports of medicinal products, and possibly its use.

(5) Where an exemption pursuant to paragraphs 1 and 2 allowed liable for damages
person at whose request the exception was allowed. Responsibility of the manufacturer or importer
for damage caused by product defects under the law ^ 12)
not affected.

(6) In the case of exemption issued for immunological veterinary medicinal product
pursuant to paragraph 1. a) Section 1
inform the Central Veterinary Administration before issuing a permit exceptions to the Commission.

§ 47

Exemptions from registration, for which the Commission decided

(1) In the event that the Commission pursuant to the rules of the European Union for some serious
Epizooties decide on the use of immunological veterinary medicinal product
^ 15), the Central Veterinary Administration with regard to
conditions in Czech Republic, unless such conditions
Commission itself, the conditions for using such a product and its marketing in the range
according to § 46 paragraph. 3rd

(2) The exemption from registration under paragraph 1 shall publish this information
:

A) the name of the product,

B) the active substance or substances contained in the medicinal product,

C) animal species and therapeutic or preventive indications for which the product
allowed to use

D) the restrictions for placing the medicinal product on the market, if it was determined
and

E) the timing of imports of medicinal products, and possibly its use.

§ 48

The exemptions from registration for veterinary medicinal products registered in another Member State


(1) Veterinary medicinal products which are registered in another Member State
may be outweighed by the relevant Member State for the purposes
application to an animal or a small number of animals at one
breeder.

(2) Veterinary medicinal products may be imported into the Czech Republic
attending veterinarian or by a person authorized to distribute
veterinary medicinal products on an order
attending veterinarian if the Veterinary Institute in accordance with paragraph 5 of such
imports declined. The order must contain data about the applicant as well as data
a veterinary medicinal product and the justification for the order.
Pattern of orders in the implementing legislation.

(3) A veterinarian who intends to import into the Czech Republic
veterinary medicinal product referred to in paragraph 1 shall be obliged to import
advance the Veterinary Institute. The application must contain data about the applicant
further information on this veterinary medicinal product, data on
placing on the market, data on the amount of product on the way
use of time for which the product is to be put into circulation and
reasons for the request. The implementing legal regulation stipulates the scope of data
cited in the application. Veterinary Institute shall assess the application and if
decides pursuant to paragraph 5 by rejecting the application within 15 working days from receipt of the request
, this period is preserved, if it was the last day of the deadline
written communication sent demonstrably Veterinary Institute, and
via postal service or electronically, the application shall be deemed approved
. Veterinary Institute may decide about possible restrictions
regarding the use of the veterinary medicinal product or its marketing
into circulation.

(4) In the case of a direct threat to the health or life of the animal, the veterinary medicinal product
under paragraph 1 shall be imported under the conditions set out in paragraph 2
without prior approval by the Veterinary Institute.
In this case, the application is submitted back within 5 working days after the implementation of such
imports. Veterinary Institute conduct an evaluation of the submitted application and
decide on it in accordance with paragraph 3. If the Veterinary Institute

Request pursuant to paragraph 5 refused competent veterinarian must
immediately terminate use of the veterinary medicinal product and ensure its removal
^ 56). Costs of removing such product
borne by the responsible veterinarian, who is also obliged to eliminate
keep detailed and legible records kept for at least 5 years.

(5) Veterinary Institute a request under paragraph 3 or 4 refused if

A) a veterinary medicinal product which is to be the subject of imports, has
valid registration in another Member State

B) in the Czech Republic is an appropriate indication of available
another suitable authorized medicinal product

C) the veterinarian has failed to provide information in accordance with paragraph 3, or

D) the veterinary medicinal product in a Member State
subject to restrictive safety measures in order to investigate
risk associated with the use of the medicinal product concerned.

(6) The attending veterinarian who imports veterinary medicinal products
pursuant to paragraph 2 shall maintain records on imports and
store them for a period of 5 years following the importation. Distributor of leading
imports pursuant to paragraph 2 in accordance with the distribution requirements
veterinary medicines. The implementing regulation lays down
range of import data.

§ 49

Specific therapeutic programs using unregistered medicinal products for human use


(1) If, in cases of directly applicable regulations of the European Union
^ 57) or in situations other emergency needs for effective treatment is not
patients, prophylaxis and prevention of infectious disease or diagnosis available
human medicinal product authorized by
this Act or the directly applicable EU-24)
may allow the use, distribution and dispensing of medicinal products for human
not registered under this Act or under the directly applicable regulations of the European
EU-24) in the context of specific treatment programs
(hereinafter referred to as "treatment program"). Draft treatment program may be submitted, if


A) subject to the treatment program, treatment, prophylaxis and prevention or diagnosis of conditions
seriously threaten human health,

B) the use of an unauthorized medicinal product is carried out according to a pre-prepared
treatment program outlining particularly

First used medicine

Second medicine manufacturer or distributor or person
importing medicinal products from third countries

Third a group of patients for whom the medicine will be used, and the way
its use

Fourth monitoring and evaluation of the quality, safety and efficacy
medicine and therapeutic benefits of its use,

Fifth work on which treatment program takes place

6th justification of the treatment program.

(2) treatment program proposal submitted by a legal or natural person
(hereinafter referred to as the "submitter of the therapeutic program")
Ministry of Health for approval and to the Department for an opinion. In its opinion,
Department expressed particular conditions of use of the medicinal product
method of its distribution, dispensing, and monitoring and evaluation of its
quality, safety and efficacy. In cases where treatment program
includes a medicine belonging to the categories under directly applicable EU regulations
^ 58), the Department in issuing opinions
into account the opinion of the Agency, if issued.

(3) treatment program can be realized and unregistered medicine
manner described in a treatment program to use, distribute and publish,
only if the Ministry of Health has issued written consent
carrying out the treatment program. The Ministry of Health will issue such
agreement in respect to the Constitution and eventually
opinion of the Agency, if issued. Approval by the Ministry of Health
may be subject to the imposition of obligations promoters treatment program
including the obligation to submit reports on the progress of the program
Ministry of Health or the Department of defining the terms of use
medicinal product, method of its distribution, supply and
monitoring and evaluation of its quality, safety and efficacy. If it is a
unregistered medicinal products containing genetically modified

Organism ^ 11), such product within a therapeutic program used
distributed and dispensed only in accordance with legal regulations
^ 11).

(4) submitted a treatment program if approved treatment program
responsible for its progress and for ensuring cooperation with authorities
referred to in paragraph 2. In case of violation of the conditions under which it was
consent is given, or if new facts about
unfavorable risk-benefit ratio of the medicinal product to which it relates
treatment program, the Ministry of health
its consent to the implementation of the treatment program appeal. The Institute may suspend the use
medicinal product if new facts about
unfavorable risk-benefit ratio of this medicinal product or
serious breach of the conditions for use of the medicinal product, its distribution or dispensing
established treatment program.

(5) Information about therapeutic programs transmitted Department
in the cases provided for in the directly applicable regulations of the European Union-57) Agency.
Implementing legal regulation stipulates the method of submission of therapeutic programs
content of their proposals and information submitted, issuing opinions and
consents thereto, the scope of information submitted to the Institute during
implementation of the treatment program, and the extent of published data.

(6) The Ministry of Health can to ensure the availability of medicines
important to provide health care services according to §
11 point. h) to publish on the official board of the conditions for use, distribution and dispensing
human medicinal products not registered under this Act or pursuant
directly applicable EU-24) within
treatment program (hereinafter referred to as "special treatment program ").

(7) A person who, on the basis and within the scope of the conditions laid down
Ministry of Health is interested to carry out special treatment
program is obliged to notify the Ministry of Health and the Institute
upon request to demonstrate compliance with the conditions of this program.
Implement special treatment program that person may, under
approval of the Ministry of Health.

(8) A person carrying out a special treatment program is required to ensure that
use of the medicine in accordance with the conditions set
Ministry of Health and to ensure cooperation with the authorities referred to in paragraph 7.
In case of breach of conditions
stipulated by the Ministry of health, or if new facts about
unfavorable risk-benefit ratio of the medicinal product to which it relates
special treatment program, the Institute special treatment program
suspend or terminate the Ministry of health.

(9) A person carrying out a special treatment program is required data
set by the Ministry of Health sent to the Ministry of Health and the Department
form of reporting procedure published by
paragraph 6. The evaluation reports conducted Institute and the results of the Ministry informs
health.

§ 49a

Request for an exemption for hospital medicines for advanced therapies

(1) Hospital exception allowing the Czech Republic in accordance with the regulations
EU-92) use of unauthorized medicinal
advanced therapy product, which is in terms of the general requirements for the production
produced abnormally but in accordance with specific standards
quality and should be used in a medical facility inpatient care in order
comply with an individual medical prescription for an individual patient.

(2) Hospital with possible exceptions only for the medicinal product
advanced therapy

A) in which, in the context of preclinical and clinical trials demonstrated
its safety and tolerability and testing efficiency, the effectiveness can be
in justified cases prove only references to published scientific literature
and

B) the producer has been licensed for the production of the corresponding type
medicinal products for modern therapy, the extent consistent
permission to manufacture investigational medicinal products.

(3) Request for hospital exemption submitted by the manufacturer of the medicinal product
. This request must contain in addition to the general requirements

A) scientific substantiation of claims and assess the balance of benefits and risks for
patients


B) evidence of preclinical and clinical data confirming the safety, tolerability and
verifying the effectiveness of the medicine,

C) documents proving the quality of the drug product, to the extent
corresponding to the requirements for clinical trials of medicinal products for advanced therapies
,

D) a detailed description of the pharmacovigilance,

E) a detailed description of how traceability,

F) justification and determine the indication or indications for which it is possible
medicine used

G) a draft summary information for the patient and doctor

H) a list of all the sites where the medicine within the hospital
exceptions administered

I) a pattern of internal and external packaging of the medicinal product which has
comply with the rules set out in § 49b paragraph. 2nd

(4) In the case of medicinal products which are or which include
genetically modified organism is part of the application for exemption and hospital
permission from the Ministry of the Environment under the Act on
use of genetically modified organisms.

(5) The request for exemption hospital Department will assess in terms of its completeness and
within 15 days of receipt of this report the result
assessment of the applicant. If the Institute shall inform the applicant of its incompleteness
application and the applicant does not complete the application within 15 days of receipt of the notice
incompleteness of the application, the Institute shall terminate the proceedings.

(6) If the request for exemption hospital Institute found complete, the Institute
a decision thereon within 60 days of notification of its completeness applicant.

(7) If the Institute during the examination of the application finds reasons for its refusal
notify these reasons the applicant and determine a reasonable period in which
may modify its request. Such amendment may make
only once.

(8) The decision authorizing the hospital exception, contains at least

A) the period for which permission is given

B) the indications for which it is possible to use a medicine,

C) the workplace, where the medicine will be given, and

D) the maximum number of patients who received the medicine will be administered.

§ 49b

Progress and completion hospital exemptions for medicines for advanced therapies


(1) the distribution of medicines for which they were allowed hospital
exemption provided by the manufacturer itself or by persons
have permission to distribute. These medicines are issued
requisition, which must be shown that it is unregistered
medicinal products that may be used with the permission of hospital
exceptions.

(2) Requirements for markings on the inner and outer packages of medicinal products
to be used within the permitted exceptions hospital,
in the implementing legislation.

(3) After granting permission for the exemption of hospital medicine is the manufacturer must


A) at regular intervals determined by the Institute least once
year, submit an assessment report on the activities of the past period, which
particular contain information on the extent of production volume within the hospital
exceptions filed medicines by individual workplaces
number of patients for whom the product is applied, evaluation of the efficacy of the medicinal product
and evaluation of ADRs,

B) ensure that medicines used in the hospital
exceptions were identified in the manner provided for in paragraph 2

C) ensure pharmacovigilance within the range specified for holders
Holder (Chapter Five).

(4) Any change in the manufacturing process of a medicinal product which has
effect on the quality of the medicinal product, including changes in the quality of the starting materials
or connect another workplace, which was not mentioned in the list of institutions
where the medicine within the hospital exceptions
given, subject to authorization by the Department. Manufacturer's application for approval of changes
served before its introduction into practice; requirements for an application for a permit
change in hospital management and exceptions of the § 49a apply mutatis mutandis.

(5) Any change in the manufacturing process of a medicinal product which has
affect the quality of the medicinal product, a change in control of the medicinal product
or change in the methods used to announce the manufacturer Institute
prior to its introduction into practice.


(6) The Institute may, before the expiry of the period for which the exemption hospital
allowed to decide on its termination in case

A) finding a breach of duty by the manufacturer

B) if necessary, based on the assessment submitted by the manufacturer reports
evaluation activities

C) the introduction of routine production process causing unfoundedness
continuation hospital exceptions

D) changes in the scope of production, or

E) changes in the assessment of benefits and risks for the patient.

§ 50

Medicines for rare diseases

If the medicinal product included in the register of medicines for rare diseases
meets the criteria laid down by the directly applicable EU regulation
^ 42), informs the Department before the expiry of five years from
medicinal product in the European Union of this fact
agency.
TITLE IV


RESEARCH, manufacturing, distribution, prescription, dispensing and removal of the active
Part 1

Research


§ 51

Clinical trials on human medicinal products

(1) In clinical trials for human medicines with the participation
individuals as subjects, the regulations
good clinical practice, which is an internationally renowned
ethical and scientific quality requirements which must
be followed when designing clinical trials on medicinal products for human
during their implementation, documentation and processing of messages and message
these trials. These rules also apply to
multicenter clinical trials, but not to non-interventional post-marketing studies.
Rights, safety and well-being of trial subjects
always prevail over the interests of science and society. Clinical trials
medicinal products must be conducted in accordance with the ethical principles laid down by European Union rules
^ 59).

(2) For the purposes of the clinical evaluation of human medicines is understood


A) clinical trials systematic testing of one or more
IMPs to verify the safety or efficacy
medicine, including clinical trials in one or more
places in the Czech Republic or other Member States | || carried out on the trial subjects in order

First to discover or verify the clinical, pharmacological or other pharmacodynamic effects
,

Second identify any adverse effects

Third study absorption, distribution, metabolism, or excretion

B) a multi-center clinical trial evaluation, which is
carried out by a single protocol but at several places
clinical evaluation (hereinafter referred to as "trial site"), and therefore few investigators
, taking place ratings may be located in the Czech Republic
, or in other Member States or in third countries
,

C) IMP dosage form of the drug substance or product obtained
technological processing only excipients
(placebo), which are being tested or used as a reference in a clinical evaluation
; It can also be already registered
medicine if used or fabricated (including changes in the composition
dosage form or container) in a manner that is different from the authorized form
medicinal product, or when used to
unauthorized indication, or to obtain further information about the authorized variant
medicinal product

D) authority natural or legal person who is responsible for
initiation, management or financing of a clinical trial;
it may only be a person who is resident or established ^ 21) in the Czech Republic
or any Member State, or a person who
appointed an authorized representative complying with this condition

E) the investigator's brochure that set of clinical and non-clinical
data on the investigational medicinal product or products
which are important for clinical trial conducted in subjects
evaluation

F) protocol document that describes the purpose, organization, methodology,
statistical considerations and organization of a clinical trial, including its
possible subsequent versions and additions

G) an evaluation of a natural person who participates in a clinical
assessment, either as a recipient of a medicinal product or as

Member comparison or control group, which is not rated
medicinal product is administered,

H) the informed consent of the expression of intent to participate in a clinical trial, which


First a writing

Second dated and handwritten signature of the trial subject

Third It is made freely after receiving detailed information on the nature,
significance, implications and risks of the clinical trial,

Fourth is appropriately documented,

Fifth any person capable of giving consent, or if that person
not capable of giving consent, by her legal representative
; if the person concerned is unable to write, it is acceptable
oral agreement made in the presence of at least one witness;
to grant such verbal consent must be recorded in writing;

Text informed consent must be clear and in a language which
trial subject well understands; implementing legal regulation stipulates the scope
data included in the informed consent and the method of its provision.

§ 52

Protection subjects

(1) The legislation relating to the protection of trial subjects are not affected by this Act
^ 60).

(2) The examiner is a physician who is responsible for the conduct of clinical trials
in the trial site. If the clinical trial at one point
evaluation conducted by a team of people refers to investigators, who leads the team
such persons as the principal investigator. The investigator must ensure that
clinical trial did not perform at

A) persons

First deprived of legal capacity or whose eligibility for
legal capacity is limited,

Second whose informed consent can not be obtained due to their
health,

Third who are not citizens of the Czech Republic, or

Fourth younger than 18 years

B) pregnant or lactating women,

C) dependents, which means the person

First in custody or imprisonment, or

Second which are provided health services without their consent;

Conduct of clinical trials of such persons is permitted only
when from it foresees preventive or therapeutic benefit to these persons
.

(3) A clinical trial may be undertaken only if

A) the foreseeable risks and inconveniences for trial subjects are exported
anticipated benefits for trial subjects and for other potential
patients; clinical trial may be initiated only if
by the ethics committee and the Institute of the expected therapeutic benefit and the benefit to justify
health risks; clinical trial can proceed only
if it is to meet this requirement continuously monitored

B) the subject or his legal representative, where
trial subject is unable to give informed consent, in addition
provisions of paragraph 7 in a previous interview with the investigator or a person authorized by the investigator
opportunity to understand the objectives, risks and difficulties
clinical trial and the conditions under which a clinical trial
take place, and if it has been informed of their right at any time from the clinical evaluation
withdraw

C) the rights of the subject to physical and mental
integrity, to privacy and data protection of his person
under special legislation ^ 60)

D) the subject or his legal representative, where
trial subject is unable to give informed consent, provided
written consent after being informed of the nature, significance, implications and risks of clinical trials
; if the trial subject is unable to write,
in exceptional cases, accept an oral agreement made under
presence of at least one witness; to grant verbal consent must be
written record

E) the subject may withdraw from the clinical trial
by revoking his informed consent without him was therefore
caused injury

F) prior to the commencement of the clinical trial insurance policy
liability for damage to the investigator and sponsor, which is ensured through
and compensation in case of death of the body
evaluation or if damage is caused to the health of the trial subject
result of the clinical trial; conclusion of such insurance is required to ensure
sponsor.

(4) Medical care given to, and medical decisions

Taken in relation to the trial subjects must be secured appropriately qualified doctor
.

(5) the subject is notified of the investigator or sponsor, from whom
may obtain further information. In the event that there is any new information relevant
consent of the subject with his participation in a clinical trial
shall be subject assessment of these facts
immediately informed the investigator.

(6) on minors clinical trial can be implemented only if


A) the informed consent of parents or other legal representative
^ 61); This consent must represent the presumed will
minors to participate in the clinical trial, if
due to her age and intellectual capacity or possible; it can be revoked at any time
, without prejudice to minors caused injury

B) the minor has received from the investigator or a person authorized by
who has experience working with minors, information
trial, the risks and benefits at a level appropriate
ability to understand the minors ,

C) investigator, principal investigator respects the express wish
minors, which is able to form their own opinion and assess
information referred to in point b) refuse to participate or withdraw at any time
from the clinical trial,

D) does not receive any financial incentive or amount besides compensation

E) the clinical trial brings direct benefits to more patients and only
if such research is critically important to validate data obtained from
clinical trials on persons able to give informed consent
or data obtained by other research methods; such research should
should relate directly to a clinical condition in which a minor suffers
or be of such a nature that it can only be performed on minors
persons

F) clinical trial in accordance with the relevant guidelines of the Commission and
agencies

G) is designed to minimize pain, discomfort, fear and any other foreseeable
risk related to the disease and
development of the trial subject; the risk threshold and the degree of stress must be
defined by the protocol and constantly monitored,

H) protocol approved ethics committee, which has experience in the field of paediatrics
or that clinical, ethical and psychosocial
issues in the field of pediatric medicine required a qualified opinion.

The implementing regulation lays down detailed specification implementation and assessment
clinical trial on minors under subparagraphs a) to h).

(7) The provisions of paragraphs 2-5 shall apply mutatis mutandis to an adult
legally incapable of giving informed consent to clinical evaluation
. Participation legally incapacitated adults under clinical evaluation
is allowed if

A) the informed consent of their legal representative;
this consent must represent the presumed will of the subject
participate in the clinical trial and may be revoked at any time, without prejudice to the subject
caused injury

B) a person who is not able to give informed consent was aware
clinical trial, its risks and benefits at a level appropriate
her abilities understanding

C) investigator, principal investigator respects the express desire
trial subject who is capable of forming his own opinion and
evaluate the submitted information to refuse participation or withdraw from
clinical trial

D) does not receive any financial incentive or amount besides compensation

E) such research is essential to validate data obtained
clinical trials on persons able to give informed consent
or data obtained by other research methods and relates directly to
clinical condition from which the organization reviews danger to life or
substantially limits his ability

F) the clinical trial is designed to minimize pain,
discomfort, fear and any other foreseeable risk in relation to
the disease and the development of the trial subject; the risk threshold and the degree of stress
must be defined by the protocol and constantly monitored,

G) protocol approved ethics committee, which has experience with relevant
disease and the patients or after clinical consultation,

Ethical and psychosocial problems in the disease and
groups of patients.

(8) Clinical trials on adult persons who are not legally
competent to give informed consent, can not be done or it
continue if it is proven that these persons expressed their disagreement or refused to give consent
the conduct of clinical trials before this
lost their eligibility.

(9) In acute situations where there prior to the inclusion of the subject in a clinical trial
possible to obtain his informed consent is requested
approval of his legal representative pursuant to paragraph 3. b).
If this shortcut is not set or is unavailable, you can trial subject
included in clinical trials only if the inclusion procedure
described in the protocol and the investigator has written a favorable opinion of the ethics committee
a given assessment, which contains an explicit
statement on the procedure for inclusion of subjects. In its statement
ethics committee may make the inclusion of each individual entity
rating their consent. The investigator obtains informed consent of the subject
evaluation, or his legal representative with continuing participation
trial subject in a clinical trial without delay as soon as it is with
state of health of the subject or the availability of a legal representative
possible.

§ 53


Ethics Committee
(1) The ethics commission is an independent body composed of experts from the health and
persons without training in the field of medicine, whose
duty is to protect the rights, safety and health subjects and
ensure this protection and expression his opinions on the protocol
clinical trials, suitability of the investigators and equipment, the methods and
documents to be used for information of trial subjects and obtain their informed consent
. Ethics Committee is authorized to establish
provider of health services. The ethics committee may, on the basis of a written agreement
concluded with the provider of health services, which it did not set,
act as an ethics committee for this
providers of health services. The Ethics Committee is also authorized to establish a Ministry of Health
; In such a case, appoint the members of the ethics committee
Minister of Health. Conditions for the activities of the ethics committee ensures operator
that it has established. This entity is also responsible for the publication of the rules
conduct and working procedures of the ethics committee and the list of its members and the
case, the ethics committee requires reimbursement of costs incurred in connection
issuing an opinion, whether disclosure of costs.
The Ethics Commission is the administrative authority and issuing opinions and procedures of the ethics committee
administrative order does not apply. The implementing regulation lays down
rules for the establishment, composition, activities, ensuring activity
disclosures and the closure of the ethics committee.

(2) The ethics committee established under this Act may issue its opinion
to other areas of biomedical research than clinical
evaluation of medicinal products, if this does not affect the provisions
other special legal regulations 62). At least one member of the ethics committee
must be a person with no medical education and without professional
scientific qualification and at least one member of the ethics committee must be a person
who is not employed, a similar working relationship or || | salaried position to medical service providers, which will
proposed clinical trial is conducted. The members of the ethics committee may be
only persons who provide written consent

A) their membership in the ethics committee, to refrain from comments on
requests for consent to the conduct of clinical trials on which
implementation have a personal interest, as well as performing expert supervision
such clinical trials, and to promptly notify the emergence of personal interest
considered for clinical trial ethics committee

B) the publication of its membership in the ethics committee and other facts
arising from the activities and membership of the Ethics Committee
under this Act

C) that they will keep confidential all information and
facts they learn in connection with their membership in the ethics committee
.

(3) The ethics committee under paragraphs 1 and 2 may be based on your request
determined by the Ministry of Health as an ethics committee

Issuing opinions on multi-center clinical trials (hereinafter
'ethics committee for multi-centric trials "). This decision shall
Ministry of Health with regard to the opinion of the Institute.

(4) Establishment of an ethics committee and determine the ethics committee for multi
evaluation, as well as the disappearance of an ethics committee and change data enabling
conjunction with the ethics committee and multicentric ethics committee will be notified immediately
Institute. This information indicates an entity that appropriate
Commission set up or asked about her destination. Information about the demise
ethics committee notified body that established the relevant committee, also
all sponsors of clinical trials over the course of a given
ethics committee and multicentric ethics committee to supervise.

(5) The ethics committee can obtain an opinion, to invite other experts to
which are also subject to the provisions of the law of conservation
confidentiality of information and facts they learn
in connection with its activities for ethics committee.

(6) Ethics Committee at the request of the contracting authority shall, before a clinical
evaluation of the given clinical trial opinion.
The sponsor is obliged to pay compensation for the costs reasonably incurred for professional
operations carried out in connection with the issuance of such an opinion.

(7) In preparing its opinion, the ethics committee shall consider

A) the relevance of the clinical trial and its design,

B) whether the evaluation of the anticipated benefits and risks according to § 52 paragraph. 3
point. a) acceptable and whether the conclusions are justified,

C) Protocol

D) the suitability of the investigator and collaborators

E) the investigator's brochure,

F) the appropriateness of healthcare providers,

G) the adequacy and completeness of the written information for trial subjects and
procedure to be followed for the purpose of obtaining informed consent
, and justification for the research on persons not able to grant
informed consent with respect to specific restrictions laid down in
§ 52 paragraph. 2-5,

H) provision for compensation or insurance in case of death or damage arising
injury as a result of a clinical trial

I) any liability for any damage done to the investigator and sponsor
through which it is provided and compensation in case of death
trial subject or, in the case of damage to health
trial subjects as a result of the clinical trial ,

J) the amount and the securing of remuneration or compensation
investigators and trial subjects and the relevant aspects of the agreements concluded between
sponsor and the site,

K) method of recruitment of subjects.

(8) Compensation, insurance and compensation under paragraph 7 letter. h) to j) shall
ethics committee assessed in terms of protecting the rights, safety and health
subjects, and to the extent specified in the implementing legislation.

(9) The ethics committee must within 60 days of receipt of the request
unless specified otherwise make for a given clinical trial of its
reasoned opinion to the sponsor and at the same time to provide the Institute.
This period shall be extended by 30 days in the case of clinical trials of medicinal
products for gene therapy or somatic cell therapy or
medicinal products containing genetically modified organisms ^ 11).
In justified cases, the extended period still extended for another 90 days
. In the case of xenogenic cell therapy is not a deadline for
opinion of the ethics committee.

(10) within which the application is being assessed for opinion
in cases specified by law, the ethics committee may send one
applicant a request for information to supplement the data that already sponsor
presented. Deadline set for an opinion shall be suspended until
until additional data are delivered to the ethics committee.

(11) Ethics Committee provides oversight of each clinical trial for
which issued a concurring opinion, at intervals appropriate to the degree
risk for trial subjects, but at least once a year. If
in case of dissolution of the ethics committee during the trial of her
action not taken over by another ethics committee, it is understood that a favorable opinion of the ethics committee
implementation of the clinical trial is
invalid. In the event of dissolution of the ethics committee for multicentric clinical

Rating action can the Commission take only the ethics committee determined pursuant to paragraph 3


(12) The ethics committee shall keep records of their activities for at least 3 years after completion
clinical trial for health providers
services. In the same way also keeps a record of which to further
healthcare providers operate under paragraph 1. Preservation
records in case of dissolution of the ethics committee ensures operator who
set up an appropriate committee or the ethics committee that activity extinct
ethics committee has taken. The implementing regulation lays down
kinds of records on the activities of the ethics committee and method of storage.

(13) Ethics Committee withdraws permanently or temporarily its consent
with the conduct of clinical trials, if there are new facts
essential for the safety of trial subjects or sponsor or investigator
seriously violates the conditions of implementation or arrangement
clinical trial, for which the ethics committee gave its assent
opinion pursuant to paragraph 6. appeals concurring opinion contains
identifying information on the clinical trial, reasoning, measures
termination of the trial, the date of withdrawal of consent and signature
least one authorized member of the ethics committee. The ethics committee except
which endangers the safety of trial subjects, before they would
appealed favorable opinion, seeks the opinion of the sponsor, or the investigator
. The implementing regulation lays down more
range of data included in the recall concurring opinion.

§ 54

Opinions of ethics committees for multi-center clinical trials

(1) In the case of multi-center clinical trial to be conducted in
Czech Republic, the sponsor shall submit a request for an opinion
only one ethics committee for multi-centric trials;
simultaneously submit a request for an opinion on the ethics committees constituted
providers of health services at the planned locations of the clinical trial (hereinafter
"local ethics committee"), and these ethics commission informs that
ethics committee for multicentric clinical evaluation of an application for
opinion on the clinical trial. Request
opinion must contain data about the sponsor, as well as data specifying the subject of the application and its justification
. The implementing legal regulation stipulates the scope of data
put in a request for an opinion and related documents that are submitted
ethics committees, details of their evaluation
messaging and positions, interaction, ethics committees and synergy
with the Institute.

(2) In its opinion, the ethics committee for multi-centric trials
consider the facts according to § 53 par. 7 point. a) to c), e), g) to k).

(3) The local ethics committee shall provide the sponsor with its opinion on the facts
according to § 53 par. 7 point. d) and f) and express its final opinion
to conduct the clinical trial at the trial site.
Local ethics committee is not authorized to require design changes
clinical evaluation and its documentation, to which the ethics committee for multi-centric trials
issued a concurring opinion, however
entitled to conduct the clinical trial in locally express disapproval | || opinion, which is final. Concurring opinion
clinical trial issued by the local ethics committee is valid only if
favorable opinion of the ethics committee for multi-centric trials.

(4) If, for some trial sites are not set up local ethics
committee can for this trial site to give its opinion
ethics committee for multi-centric trials.

(5) In the case of multi-center clinical trials conducted
parallel in several Member States and the Czech Republic formulates
Department unanimous opinion for the Czech Republic. This opinion is
affirmative only if the ethics committee for multi
trials and the Institute have issued the given clinical trial, or to
amendments to its protocol standpoint.

(6) Appeals concurring opinion with the conduct of clinical trials
according to § 53 paragraph. 13 local ethics committee refers to a specific place
evaluation; appeal concurring opinion
ethics committee for multi-centric trials has resulted in the termination of the trial
Czech Republic. The ethics committee for multi-centric trials, with the exception of

Cases where safety is at risk of trial subjects before
would revoke the favorable opinion, seeks the opinion of the sponsor, or the investigator
and local ethics committees.

§ 55

Commencement of clinical trial

(1) A clinical trial may be initiated by the contracting authority only if

A) the given clinical trial issued a favorable opinion of the ethics committee
,

B) Institute has issued permission to start a clinical trial or has not rejected
clinical evaluation in accordance with paragraph 5 shall be subject to notification, or the sponsor
announced that clinical trials against ohlašovanému
no objections.

(2) The application for clinical trial authorization or request, which heralds
clinical evaluation in accordance with paragraph 5, filed authority
assess the Department in terms of its completeness and no later than 10 days from its receipt shall communicate the outcome
this assessment authorities. If
Department informs the sponsor of incompleteness of his application, the sponsor may supplement
request for authorization or notification of a clinical trial with regard to
these facts; such supplementation is permitted to make only once.
If the sponsor means a request for authorization or notification
clinical trial fails within 90 days of receipt of notification,
proceedings on that application Institute of stops. Authorization pursuant to paragraph 6
case of medicinal products containing genetically modified organisms
Department issued upon proof of fulfillment of the conditions to the special legal regulation
^ 11). In the case of radiopharmaceuticals, request the opinion
Department of State Office for Nuclear Safety, which issued an opinion in such
within 30 days of receipt of request.

(3) If the application for clinical trial authorization or a request for
notification of clinical trials found complete, the Institute shall examine

A) within 60 days of notification sponsor of its completeness or

B) within 90 days in the case of clinical trials on medicinal products pursuant to paragraph 6
, with the exception of medicines not registered in the Czech Republic or
Member States which have not obtained
biotechnology processes. In cases of particularly complex expert assessment
this period shall be extended by 90 days to 90 days.

(4) If the Institute during the examination of an application for authorization of a clinical trial or
request for notification of clinical trials finds reasons for its rejection
shall notify the sponsor and determine a reasonable
period within which it can contracting authority to modify its application so that the reasons for its rejection
been removed. Such amendment may make
only once. If the sponsor manner
application for authorization of a clinical trial or a request for notification of clinical trials within the prescribed period
redressed, the Institute shall notify the sponsor in writing that his
request is denied. The deadline for examining the application for authorization of a clinical evaluation
xenogenic cell therapy is not limited.

(5) Notification shall be subject to a clinical trial in which a
medicinal products used only products registered in the Czech Republic or
Member States, and such products are not registered in
Czech Republic or the Member States which
not obtained by biotechnological processes and not the products that contain substances
human or animal origin. The reported clinical trial is
allowed if the Institute within 60 days of notification of the completeness of the application of this
disapproves the application, and notifies the sponsor of the clinical trial is
dismissed, while maintaining the deadline, if it was the last day of the period in writing
Communication Institute demonstrably sent. If the investigational medicinal products
used in accordance with the marketing authorization in the Czech Republic
shortens this period to 30 days.
Announced clinical evaluation is also allowed if they give the Department
sponsor before the expiry of the periods referred to in the second sentence and the third that against ohlašovanému
clinical trial does not object.

(6) Commencement of clinical trial not specified in paragraph 5, especially
such a clinical trial in which the medicinal products are
nature of gene therapy, somatic cell therapy including xenogenic
cell therapy or contain genetically modified organisms ^ 11)
is subject to the authorization of the Institute. Clinical trials nature
gene therapy, which results in the modification of the genetic identity of the entity

Assessment may be carried out.

(7) A request for an opinion of the ethics committee, an application for authorization
clinical trial or request for notification of a clinical trial must
contain data about the applicant as well as data specifying the subject of the application and its justification
. The implementing regulation lays down the scope of application
opinion of the ethics committee, an application for authorization of a clinical trial or
request for notification of clinical trials and content
submitted documentation. Detailed instructions on the form and extent of these
applications and documentation relating to clinical trials published
Commission, the Agency and the Institute.

(8) The sponsor shall immediately inform the Institute and the ethics committees of
trial commencement. Clinical trial authorization shall cease
valid unless clinical trial commence within 12 months of issuance
permission. Permission to launch a clinical trial reported in accordance with paragraph 5
can be used for 12 months from the date of such authorization. In the event that
later than 30 days before the expiry of the sentence by the second or third
contracting Institute demonstrates that changes have occurred facts under which
clinical trial was assessed and requests for extension of validity of the authorization
or to extend the period during which it can use
permission to launch notified clinical trial, Institute
validity of the license or the period for which the sponsor may use the authorization to initiate announced
clinical trial to further 12 months if it finds the
sufficient proof. The implementing legal regulation stipulates the scope and method of informing
Institute and the ethics committee authority to initiate clinical evaluation
.

(9) The sponsor provides free medicinal products and potential
devices used for their administration. If the sponsor is the investigator,
medical service provider, university or state
through its organizational units, and medicinal products are registered
in the Czech Republic, not of IMPs
free compulsory. For such clinical trials, which do not involve
manufacturers of medicinal products or persons commercially associated therewith,
implementing legal regulation stipulates the scope and method of recording and storing
documentation and further adjust the technical requirements for the manufacture or import of
third country.

(10) The contracting authority is entitled by contract to ensure fulfillment of their obligations
relating to clinical trials by another person;
his responsibility for the accuracy and completeness of data on the clinical trial that is
affected.

§ 56

Progress and completion of clinical trials

(1) The contracting authority may, after the commencement of the clinical trial protocol
changed only through amendments. In the event of significant changes to the protocol

A) notify the sponsor protocol amendment before the application of the Constitution and
simultaneously communicate the reasons for these amendments;
same way inform the ethics committee or the ethics committee that the given clinical trial
express their opinion (hereinafter "the ethics committee");
Implementing legal regulation stipulates the scope of data to be provided in the notification, the notification method
protocol amendments and changes to the protocol that
considered significant

B) the ethics committee issues its opinion on the amendments notified her
protocol no later than 35 days from the date of notification;
if multicentre trial has issued an opinion that
ethics committee for multicentric clinical trials which has already issued an opinion on
initiation of the clinical trial, and provide it immediately to all
ethics committees for individual sites of the clinical trial ,
sponsor and the Constitution; local ethics committee in an opinion
proceed in accordance with § 54 para. 3; if the local ethics committee issues
dissenting opinion to the protocol amendment, may also revoke
consent to the conduct of clinical trials locally,

C) The Institute will consider notified protocol amendments.

(2) If the opinion of the ethics committee notified Appendix
Protocol consistent and Institute or the competent authorities of other Member States
where the trial is being conducted, not communicated to the sponsor within 30 days
that amendment Protocol dismissed, the sponsor may supplement
protocol to incorporate and implement it, while maintaining the deadline, if
last day written notification Institute demonstrably sent.


(3) If there is in connection with the conduct of clinical trials or development
IMP new fact which may
affect the safety of trial subjects, the sponsor and investigator
obliged to take immediate measures to protect
subjects against any immediate hazard. Paragraphs 1 and 2 are not affected by this
. The sponsor shall forthwith inform these new facts and measures taken
Institute and the relevant ethics committee.

(4) The sponsor regularly evaluated and updated set of information
investigator, and at least once a year.

(5) Within 90 days after the end of the trial
notify the Institute and the relevant ethics committees that the clinical trial has ended.
If there is a termination of the trial prematurely shortens
period under the first sentence to 15 days; In this case, the sponsor shall
reasons for early termination.

(6) The sponsor shall notify the information under paragraph 1. a) and paragraphs 4 and 5 and
§ 58 para. 4 also to the competent authorities of other Member States, in
where the trial is being conducted.

(7) Documentation of a clinical trial, with the exception of documentation by
special legal regulation 63) are required to sponsor or the investigator
kept for at least 5 years from the completion of clinical trials.
Implementing legal regulation stipulates the scope and method of storage of documentation
authority or investigator.

(8) The Institute shall ensure that data defined by Commission guidelines into a common database
European Union. At the request of a Member State, Agency or Commission
Department will provide any additional information relating to the present
trial.

(9) The Department shall suspend or terminate the clinical trial
if the conditions of application for authorization or notification of a clinical trial and
in the documentation are not met or if
received new information that is essential for
safety of trial subjects or scientific justification of the trial. Unless
jeopardized the safety of trial subjects, the Institute before suspends or terminates
conduct of the trial, request the opinion of the sponsor, or the investigator
; This opinion of the sponsor or investigator
Institute delivers up to 7 days. Institute for Clinical evaluation
suspend or terminate in the event of termination without a legal successor sponsor. About
suspension or termination of the trial and the reasons
Department immediately inform the relevant ethics committee.

(10) In case of the sponsor, the investigator or any other person
involved in the conduct of clinical trials failed to meet
obligations Institute that person shall immediately inform the faults and saved her
corrective measures. About his procedure Department immediately inform the relevant
ethics committee.

(11) The investigator or medical service provider, which is or was carried
clinical trial are obliged to make
medical records of subjects surveyors carrying
checking compliance with legal and regulatory requirements in the clinical trial || | at their request.

(12) The Institute shall immediately inform the competent authorities of other Member States
where the trial is being conducted, and the Commission

A) measures pursuant to paragraph 9 of the reasons for such action;
In this case, the Institute shall also inform the Agency

B) measures in accordance with paragraph 10.

(13) The sponsor, investigator and all persons involved in the clinical evaluation
are obliged to follow the rules of good clinical practice, while
follow the instructions of the Commission, agencies and specifying guidelines
Institute.

§ 57

Manufacture of investigational medicinal products, imports from third countries and
supervision of the conduct of clinical trials

(1) The manufacture of medicinal products and their import from third countries
subject to manufacturing authorization. The manufacturing authorization shall not be required
for treatment prior to use or for repacking, if these activities are carried out
provider of health services by persons authorized medicinal products
prepare or edit, and if the investigational medicinal product is intended for
use exclusively with the providers of health services
.

(2) The packaging of investigational medicinal products are given basic information

In the Czech language. The implementing regulation lays down the method of labeling and
changes to information shown on the packaging, which are carried out in
during the trial.

(3) Department verifies compliance of good clinical practice and good manufacturing practice
on positions related to clinical trials, especially
site or trial sites, the manufacturing site of the medicinal
product used in laboratories for analyzes in the clinical evaluation
au sponsor. Report drawn up for each inspection, the Institute will provide
under conditions of confidentiality authorities and on request
well as the relevant ethics committee. After an agreement with the Institute and after the announcement
contracting authorities can verify compliance with the conditions of good clinical practice as well
competent authority of a Member State.

(4) The inspections carried out pursuant to paragraph 3 of the Constitution notify the agency.
The Institute also performs at the request of the Agency inspections to verify the fulfillment
conditions of good clinical practice and good manufacturing practices in the production
IMPs. Department
provide the competent authorities of other Member States and the Agency to request such a report on the inspection done
. The Institute may request the Commission to the trial site, as well as spaces
sponsor or manufacturer of the medicinal product which is
in a third country, have been checked for the European Union.

(5) The Institute shall recognize the results of checks carried out on behalf of the European Union
competent authorities of another Member State.

§ 58

Reporting of adverse events and reactions and reporting

(1) The investigator shall immediately report to the sponsor manner and within the time
specified in the protocol or the IB
serious adverse events, except for those events that the protocol or file
IB called for events
not requiring immediate reporting. Subsequently, the sponsor will provide a detailed written report, while
trial subjects are identified by assigned identification codes.
Adverse events and laboratory abnormalities identified Protocol for
critical for the safety assessment reports investigator
authorities in accordance with the protocol requirements and within the time limit set by the protocol.

(2) In the case of the reported deaths of trial subjects the investigator shall provide
authorities and relevant ethics committee
all the additional information.

(3) The sponsor leads the extent specified protocol of the clinical evaluation
records of all adverse events which have been reported
investigator. These records shall supply
Institute and the relevant authorities of the Member States on whose territory the clinical trial is being conducted.

(4) The sponsor shall ensure that all information about suspected serious
unexpected adverse reactions which are fatal or life-endangering
trial subject are recorded and reported to the Institute and the relevant ethics committees
within 7 days from the day when the sponsor
learned of this fact, and that subsequent clarifying
information was then forwarded to the next 8 days. Sponsor at this
action shall proceed in accordance with the guidelines of the Commission and agencies.

(5) The sponsor shall ensure that suspected unexpected serious adverse
effects not mentioned in paragraph 4 have been reported to the Institute and the relevant ethics committees
later than 15 days from the day when the sponsor of this fact learned
.

(6) The Institute shall ensure that all communicated to him
suspected unexpected serious adverse reactions to a medicinal product has been
recorded.

(7) The sponsor shall forthwith inform investigators about all notified to
suspected serious unexpected adverse reactions
medicine.

(8) During the clinical trial provides the Institute and the ethics committee
every 12 months, and no later than 60 days after the end of this
period report during the trial. The sponsor also provides
Institute and the ethics committee at least every 12 months
interim safety report. The implementing legal regulation stipulates the scope of data
cited in the report on the conduct of clinical trials and the scope of data
reported in the interim report on security, including the time limits
its submission.

(9) The sponsor shall ensure the entry of suspected serious

Unexpected adverse reactions to a medicinal product which has been
warned the European database. In justified cases and after
prior discussion with the client can insert data
suspected unexpected serious adverse reactions to a medicinal product to the European database to ensure
Department.

§ 59

Change sponsor

(1) The contracting entity may lodge Institute transfer request
all of its obligations to another natural or legal person who enters this
transfer fully to its rights and obligations.
The application must contain data about the applicant as well as data specifying the subject of the request, his
justification, and the date on which the transfer is to be effected.
The application must be accompanied by the consent of the person to whom they are duties and functions
sponsor transferred. Application may be made only in relation to one
clinical trial. The implementing legal regulation stipulates the scope of data and content
submitted documentation contained in the application for change of the sponsor.

(2) Department request for a change of the sponsor assess and within 30 days of its receipt
issued a decision confirming the requested change or reject
.

(3) The change of sponsor, stating the names and addresses of new
contracting authority, in the case of a legal person, or a name or names,
surname and place of business of the new sponsor, in the case of a natural person,
new entity shall promptly notify the relevant ethics committees and
investigator.

§ 59a

Interventional post-marketing studies

(1) Investigator non-interventional post-marketing studies specified in § 93j and 93k
shall immediately notify the Department of commencement and termination of non-interventional post-marketing studies and
within 180 days after the date of completion of data collection
submit the final report of the Institute.

(2) Investigator non-interventional post-marketing studies referred to in paragraph 1
means the person who is responsible for the design, initiation, conduct and evaluate
non-interventional post-marketing studies. Solver can be
MAH, contract research organizations, physician
provider of health services, professional medical society, medical or pharmaceutical
Faculty of Science.

(3) The implementing regulation lays down the method and content requirements
notice of initiation and termination of non-interventional post-marketing studies
not mentioned in § 93j and 93k carried out in the Czech Republic.
Implementing legal regulation stipulates the content and format of the final report.

Clinical trials of veterinary medicinal products

§ 60

(1) A clinical trial of veterinary medicinal products means
their scientific evaluation, which is carried out on target species
to verify at least one scientific conjecture, which concerns
efficacy or safety of the veterinary medicinal
of the target species. Clinical trials of veterinary medicinal products
usually preceded by pre-testing.
Preclinical testing of veterinary medicines is performed on biological systems or animal
under the conditions laid down by special legal regulations 35) and
progresses in him according to the rules of good laboratory practice.

(2) Clinical trials of veterinary medicinal products is carried out under the conditions laid down
for designing, implementing, monitoring,
documenting, auditing, analysis and processing, and reporting on these evaluations
(hereinafter "the right veterinary clinical practice ").
The implementing regulation lays down the rules of good veterinary clinical practice
.

(3) conditions for clinical trials of veterinary medicinal products

A) permits Veterinary Institute

B) the consent of the breeder of the animal that expresses breeder
based on detailed knowledge of all aspects of the clinical evaluation
veterinary medicines, which may affect its decision
voluntarily consent to their animals in the clinical
evaluation of veterinary medicinal products;
obtaining this consent must be documented,

C) consent regional health authorities responsible for the place where he has
clinical trials of veterinary medicinal products perform,

D) approval of the relevant state body under a special legal regulation
^ 64).

(4) To obtain an authorization under paragraph 3, the sponsor shall submit

Veterinary Institute application for clinical trial authorization
veterinary medicinal products, accompanied by

A) administrative information and scientific documentation of the clinical trial
veterinary medicinal products that fully describes the objectives, design, methodology and organization
clinical trial
use of statistical methods in clinical trials and the reasons why
the clinical trial is conducted (hereinafter referred to as "clinical trial protocol")

B) proof that the conditions of special legislation, 11), in the case of
veterinary medicinal product containing genetically modified organism
,

C) proof of payment of administrative fees and reimbursement of expenses.

Application for clinical trial authorization of veterinary medicinal products
must contain data about the applicant, approval pursuant to paragraph 3. b) to
d) and the reasons for the request. The implementing legal regulation stipulates the scope of data
cited in the application and scope of data specified in the protocol of the clinical evaluation
.

(5) Veterinary Institute after fulfillment of the conditions pursuant to paragraph 3. b) to
d) and paragraph 4, the Contracting Authority will evaluate applications for authorization
clinical trials of veterinary medicinal products in order
assessments, in particular whether

A) contracting suggested adequate withdrawal period and take such
measures to ensure its compliance, if the clinical evaluation included
animals from which they are derived
animal products intended for human consumption; in the case of substances for which no
in accordance with applicable regulations of the European Union ^ 5)
set maximum residue limits must be adhered to at least the standard withdrawal
period under § 9. 10

B) the authority is able to fulfill its obligations and that also created
sufficient conditions for fulfilling the duties of the investigator according to § 61 paragraph.
4 and persons conducting supervision over the clinical trial
veterinary medicinal products pursuant to § 61 paragraph . 5th

Implementing regulation provides for the sponsor, the investigator and the person conducting
oversight of clinical trials of veterinary medicinal products
detailed definition of the scope of activities in the implementation of the clinical evaluation
.

(6) Veterinary Institute on the application for clinical trial authorization
veterinary medicines will decide within 60 days of the conditions
pursuant to paragraph 3. b) to d) and the submission of a complete application and
additional data and documentation pursuant to paragraph 4. The decision
Veterinary Institute determined with regard to the contracting authority pursuant to paragraph 5
point. a) the withdrawal period, if the clinical trial is conducted on
animals, which are obtained from animal products for human consumption
. The decision of the Veterinary Institute may also provide conditions for
conducting a clinical trial of veterinary medicinal products;
such conditions Veterinary Institute may also provide for a subsequent permit
clinical trial.

(7) Veterinary Institute may, when considering an application for authorization of a clinical
evaluation of veterinary medicinal products in the event of deficiencies
request the applicant to supplement the submitted data and documentation.
If Veterinary Institute exercises this option, the proceedings shall be suspended.
Interruption time begins on the day when the Veterinary Institute made the call, and the procedure continues
day following the day when the required supplementation
request was delivered to the Veterinary Institute. Similarly, in the case
necessary, suspend the proceedings for a period fixed by the sponsor to provide
explanation. If management takes a break of at least 180 days, you can control
stop.

(8) Veterinary Institute application for clinical trial authorization
veterinary medicines and reject the ongoing case
clinical trial will decide on its suspension or termination, if


A) the assessment of an application proves that the sponsor has failed to comply
conditions for authorization of a clinical trial

B) it is shown that the evaluation of veterinary medicinal product is not
conditions for clinical trials of veterinary medicinal products
safe, including cases where the administration of the veterinary medicinal product
animals may result in an adverse effect on food derived
from these animals

C) qualitative and quantitative composition of the veterinary medicinal

Product does not match the data and documentation attached to the application for
clinical trial

D) Clinical trials of veterinary medicinal products is conducted
under conditions for which the license was granted

E) the sponsor or a person participating in the clinical trial
veterinary medicines, seriously violates the obligations
laid down in this Act or special legislation relating
with the care of animals ^ 35) or | ||
F) will void the sponsor.

(9) Amendments to the conditions of the clinical trials of veterinary medicinal products
against the conditions under which such a permit has been issued,
sponsor shall inform in advance the Veterinary Institute; change may be made after
within 30 days of notification, unless within that period, the Veterinary Institute
issued opposed its implementation will not require additional or
documents; changes related to the contact details of the contracting authority may
perform and immediately inform the Veterinary Institute; These amendments provide
implementing legislation.

(10) clinical trial of veterinary medicinal products
expires, unless the clinical trial
started within 12 months from the issue of the permit.

§ 61

(1) The sponsor, investigator and all persons involved in the clinical evaluation
veterinary medicines act in accordance with
principles of good clinical veterinary practice, including maintaining
confidentiality and secrecy. Clinical trials of veterinary medicinal products
not be started if the foreseeable risks and inconveniences
outweigh the expected benefits.

(2) The sponsor is also obliged

A) identify the investigator with regard to his qualifications, character
clinical trial of veterinary medicines and equipment
device, which is to be conducted this clinical trial, and
ensure that the protocol and described in compliance with the protocol and
done; implementing legal regulation stipulates the content of this Protocol and
way his leadership

B) inform the Veterinary Institute

First the initiation of clinical trials of veterinary medicinal products and
device, which has to be done; implementing regulation provides
way of informing,

Second promptly about new findings about
veterinary medicinal product, including serious unexpected adverse reactions;
unexpected serious adverse reaction that resulted in the deaths or endangered animal
to life or cause animal suffering or excessive pain,
entity shall notify within 7 days, other serious unexpected adverse reactions
notified no later than 15 days,

Third on measures of foreign states relating to the assessed
veterinary medicinal product

Fourth immediately to interrupt the trial
veterinary medicinal products

Fifth During clinical trials of veterinary medicinal products, and
within 60 days after the end of every 12 months during,

6th the end of clinical trials of veterinary medicinal products
report spelling out the details of the person who developed the report, data on
antecedent clinical trials of veterinary medicinal products
information on preliminary conclusions on the measures and changes made in || | during clinical trials of veterinary medicinal products;
Implementing legal regulation stipulates the scope of data included in the report,

C) provide the investigator for the clinical trial design
veterinary medicinal products, medicinal product manufactured in accordance with
principles of good manufacturing practice and keep a sample.
Implementing legal regulation stipulates the method of labeling these medicines.

(3) The sponsor may submit an application for change of the sponsor to another legal person
. In this case proceed in accordance with § 59 of the same pattern,
that the request is submitted to the Veterinary Institute.

(4) The examiner is obliged to conduct the clinical trial
veterinary medicinal products in accordance with this Act and is responsible for the leadership
groups of persons conducting their own clinical trials of veterinary medicinal products
. The investigator is also obliged

A) to ensure safe handling of the veterinary medicinal product
,


B) immediately inform the Veterinary Institute and the sponsor of any serious adverse event
unless the clinical trial protocol specified
otherwise

C) take the necessary measures to protect the life and health of the animal, including
possible interruption of the clinical trial;
measures to avoid immediate danger to the animal is not considered to change the terms
clinical trial

D) promptly notify the Veterinary Institute and the sponsor actually
significantly affecting the conduct of the trial or causing
increased risk for animal

E) provide for 15 years of preservation of the clinical trial;
Implementing regulation provides evidence of a clinical trial that
be kept,

F) to ensure the confidentiality of all information

G) observe hygienic principles in relation to food of animal origin
target animals.

(5) The person conducting supervision over the clinical trial
veterinary medicinal products ensures that this clinical trial is conducted,
documented and the results reported in accordance with the protocol of the clinical
assessment, standard operating procedures, proper
veterinary clinical practice, the requirements for clinical trials of veterinary medicinal products
established by this Act and any conditions for that
conducting a clinical trial of veterinary medicinal products provides
veterinary Institute or the national competent authority according to § 60 paragraph. 3 point.
D).

(6) The sponsor fulfills the obligations according to § 51 paragraph. 2 point. d) analogy.

(7) The sponsor will bear the expenses incurred by the Veterinary Institute in
clinical trial of veterinary medicinal products in accordance with § 112
Part 2


Production, preparation and distribution of drugs
Section 1


Production

§ 62

Manufacture and import of medicinal products from third countries

(1) Medicines are authorized to produce the person to whom such an activity allowed
Institute or the Veterinary Institute. Permission is also subject
manufacture medicines for export and for clinical
evaluation and production of intermediate medicines.
Authorization for production shall also be required for imports of medicinal products from third countries
where the person providing such imports must be available for each batch of medicinal product
proof of the quality controls carried out in accordance with
dossier . For these imports are used
provisions of this Act for the manufacture of medicinal products accordingly.

(2) permit to manufacture medicinal products in accordance with paragraph 1 (hereinafter
"authorization to manufacture") are subject to complete manufacture, partial manufacture and any
manufacturing processes, including repacking, packaging or presentation.
Institute or the Veterinary Institute may allow manufacturers of medicinal products in
justifiable cases, to have certain stages of manufacture or
control of other persons; in the case of those operating in the Czech Republic
, such persons must be manufacturers of medicinal products or
control laboratories. Liability for damage
manufacturer of medicinal products which entered part of the production, in which case
remains unaffected. The manufacturing authorization is not required for preparation, dividing,
changes in packaging or modification of packaging, where such activities are carried
under the conditions provided by this Act in a pharmacy or
other workplaces where medicinal products may be prepared by
§ 79 paragraph. second

(3) The Institute or the Veterinary Institute may suspend manufacture or imports from third countries
or suspend or revoke the manufacturing authorization for a group
medicinal products or for all medicinal products, if

A) the information changes or conditions or obligations referred to in § 63 para. 5
or pursuant to § 67 para. 2, or

B) not fulfilled the obligations set out in § 64, § 66 para. 1-4, § 67 paragraph
. 3, 4, 7 or 10 or § 73

And does not fulfill the obligation of the manufacturer or transfusion service
to report a change. The Institute or the Veterinary Institute suspends permits
production in those cases where the information is incomplete or
identified those deficiencies that are removable nature.
Institute or the Veterinary Institute shall revoke the manufacturing authorization in those cases where
obtained information is complete or such shortcomings are identified which are not

Removable nature. An appeal against the decision to suspend production
or imports from third countries or suspend or revoke a permit to manufacture
no suspensive effect.

§ 63

Authorizing the manufacture of medicines

(1) An application for a permit to produce served natural or legal persons
Institute or Veterinary Institute. The application must include

A) data about the applicant, data specifying the subject of the request and its justification
,

B) the place where they are medicinal products manufactured or inspected
identifying medicinal products and pharmaceutical forms to be manufactured or imported
from third countries

C) proof that the applicant has the required activity
suitable and sufficient premises, technical equipment and control facilities
complying with the requirements of good manufacturing practice laid down
implementing legislation, taking into account the provisions of § 31 para. 5
point. d) and e)

D) proof that the applicant has secured the services of at least one
qualified people for production.

Implementing legal regulation stipulates the scope of data.

(2) The Institute or the Veterinary Institute may require from the applicant
further information or documents relating to the information included in the application for a permit to manufacture
, including information about the fulfillment of the requirements for
qualified person for the area productions. If the applicant was requested in writing to supplement
application management is delivering this call interrupts.

(3) If a stay of proceedings pursuant to paragraph 2 has lasted at least 90 days
can control the manufacturing authorization or amend it to stop.

(4) The Institute or the Veterinary Institute shall decide on the application for a permit to manufacture
within 90 days of its receipt. The manufacturing authorization shall be issued after verification of the eligibility of the applicant
fulfill the obligations pursuant to § 64 when the anticipated
production. The competent Institute keeps records issued by the manufacturing authorization
manufacturing sites and scale of production, including persons who has been commissioned
certain stages of manufacture or control.

(5) In the manufacturing authorization shall state the areas in which they can perform
manufacture, dosage forms of medicines that may be produced, and
qualified person or qualified person of the manufacturer.
To ensure compliance with requirements set out in paragraph 1. b) to d)
may be part of the license to manufacture and obligations imposed on the applicant.
Such obligations may be imposed after the entry into force of the decision on permission to
production, and this decision to change the license to manufacture under the control
initiated by the Institute or the Veterinary Institute on its own initiative.

(6) The manufacturer of medicinal products is required to apply in advance
Institute or the Veterinary Institute for variation to manufacturing authorization for the intended changes
relative to the conditions under which the permit was issued.
Institute or the Veterinary Institute shall decide on such request within 30 days of its receipt
. In cases where it is necessary to carry out an investigation at the production site
this period shall be 90 days. Request for change must contain data about the applicant
and the desired change. The implementing legal regulation stipulates the scope of data
cited in the application.

(7) Changes to the data necessary to ensure cooperation of the department
manufacturer of medicines, particularly in the event of a quality defect
medicine, announces a manufacturer of medicinal products
Institute or the Veterinary Institute without delay; These changes are not considered changes
permission to manufacture.

(8) Manufacturing authorization respective institute canceled at the request of the person to whom it was issued
, or under the conditions specified in § 62 paragraph. 3rd

(9) At the request of the manufacturer of medicinal products, the exporter or the competent authorities
third country in which the medicinal product imported
Institute or the Veterinary Institute, according to its competence certify that a manufacturer of medicinal products is in possession
permits for production. When issuing such certificates
comply Institute or the Veterinary Institute the following conditions:

A) take into account the administrative arrangements of the World Health Organization
^ 65)

B) for medicinal products authorized in the Czech Republic, which
are intended for export, supply the approved summary of product characteristics.

If the manufacturer of medicinal products MAH,
submit to the Institute or the Veterinary Institute justification is not healing

Product registered in the Czech Republic.

§ 64

Manufacturer's obligations medicines

Manufacturer of medicinal products is obliged

A) to ensure stable and continuous services of at least one qualified person
for the manufacture of medicinal products (hereinafter referred to as the "qualified person
producer ') which complies with the conditions set out in § 65;
enable the qualified person of the manufacturer to perform its duties and equip it
necessary authorizations; if the producer of medicines
physical person and meets the conditions set out in § 65 can be simultaneously
QP of the manufacturer,

B) ensure that all manufacturing activities related to registered
medicines are conducted in accordance with the law,
dossier and the marketing; in the case of manufacturing
evaluated for human medicines to ensure that all
production activities carried out in accordance with the information submitted
authority under § 55 and approved in the context of an application for authorization or notification
clinical trial

C) regularly review their manufacturing methods in the light of developments in science and technology
and approval by appropriate changes in registration made him
medicinal products necessary to introduce changes into production,

D) Establish and ensure conditions for the operation of a quality control
so that the body was independent of other organizational units
manufacturer of medicinal products

E) ensure that the person responsible for quality control, which is sufficiently
qualified for this purpose; This person has one or more
quality control laboratories appropriately equipped
staff and facilities for carrying out the necessary examination and testing of the starting
materials and packaging materials and the testing of intermediate and final
medicines or has secured option
use the services of such laboratories

F) develop and implement a system for recording and assessing complaints and
complaints regarding the quality of medicinal products including measures allowing
if necessary, immediately download a batch
medicinal product from circulation; of any defect that could result in the withdrawal
medicine or abnormal restriction on supply
medicinal product, the manufacturer of medicinal products shall immediately inform
Institute or Veterinary Institute, where appropriate, the competent authority of another Member State
and the Agency

G) in the case of investigational medicinal products, in collaboration with
authority to establish and implement a system for recording and assessing
complaints and claims referred to in subparagraph f) accordingly, and ensure
identify all trial sites and, if necessary indicate the countries of destination;
in the case of an investigational medicinal product for which it was issued
Holder, the manufacturer of a medicinal product for human use
, in cooperation with the sponsor, the holder of
registration of any failure that could
related to the authorized medicinal product

H) ask the Institute or the Veterinary Institute for variation to manufacturing authorization pursuant
§ 63 paragraph. 1 point. b) to d) and. 6

I) allow employees of authorities entitled to inspect any time
access to the premises, which is used for its activities,

J) act in accordance with the manufacturing authorization, follow the rules
good manufacturing practice and guidelines of the Commission and of the Agency;
this provision shall also apply to medicinal products intended only for export;
rules of good manufacturing practice in the implementing legislation,

K) used as starting materials for the manufacture of the veterinary medicinal product
only active substances which have been manufactured in accordance with the rules
good manufacturing practices in the production of raw materials and guidance of the Commission and of the Agency;
Manufacture of active substances used as starting materials include complete
manufacture, partial manufacture, import from third countries, distribution, packaging or presentation prior
use in veterinary medicine, including
labeling, which performed by contractors,

L) used as starting materials for the manufacture of a medicinal product
only active substances which have been manufactured in accordance with good manufacturing practice
for medicinal substances and have been distributed in accordance with
good distribution practice for medicinal substances; manufacture of drugs

Includes full production, partial manufacture, import from third countries, distribution, packaging or modification
before using them, including repackaging and relabeling
carried out by contractors; For this purpose, he shall producer
medicinal product, whether manufacturers and distributors of drugs
with good manufacturing practice for medicinal substances and
good distribution practice for medicinal substances by conducting audits at the manufacturing sites and distribution of drugs
; this verification can also be done through him
authorized person, taking his responsibility remains intact,

M) used in the production of medicinal product only
such auxiliary substances which are suitable according to the appropriate good manufacturing practice
determined on the basis of a risk assessment in accordance with the instructions of the Commission; when
risk assessment taking into account the requirements under other appropriate systems
quality, as well as the origin and intended use of the excipients and previous
occurrence of quality defects, the manufacturer shall ensure that the following
established good manufacturing practice applied; the measures taken
leading manufacturer documentation

N) in the case of medicinal products for human and promptly inform the Institute
MAH immediately if the medicines
who is entitled to produce or import from third countries that are counterfeit or
they are suspected of being counterfeit, without
regardless of whether those medicinal products for human
distributed in accordance with the law or in conflict with them; This includes
mail-order dispensing with electronic means through
information society services under a special law,

O) in the case of human medicines verify that manufacturers
importers and distributors from whom he obtains active substances are registered with
competent authority of the Member State where they are established

P) in the case of human medicines to verify the authenticity and quality
active ingredients and excipients,

Q) to ensure that the manufacturing processes used in the manufacture
been validated in accordance with good manufacturing practices, particularly for the production
immunological medicines and blood derivatives, and to comply
between batches,

R) provide for the production of blood derivatives and other human
medicines subject to registration, which contain substances
from human blood or human plasma, according to the state of development of the technology was
guarantee the absence of specific viral contamination,

S) in the case of immunological medicinal products present on request
Institute or the Veterinary Institute before placing each batch
product into circulation copies of all documents on quality control
signed by the qualified person in accordance with § 66 para. 1 3

T) to notify the Department of the method used to reduce or eliminate pathogenic
viruses that can be transmitted by medicinal products pursuant to subparagraph m)

U) have available, if it is a production of the finished medicinal product in the Czech Republic
proof of quality controls for each batch of medicinal product
proof of quality controls carried out on the ingredients of a medicinal product
and quality controls carried out at an intermediate stage of the manufacturing process
,

V) keep samples of each batch of product and raw materials, including
samples evaluated for human medicines and raw materials used for their manufacture
; implementing legal regulation stipulates the scope and method
sample preservation

W) if imported medicines, including assessed
medicinal products imported from third countries only those medicines that
been manufactured by manufacturers who have been granted proper authorization for such production and who
governed by such standards of good manufacturing practices, which are
least equivalent to those laid down in this Act,

X) follow in case of radiopharmaceuticals production demands special legal regulation
^ 13).

§ 64a

Not pay

§ 65

Professional qualification qualified person of a manufacturer of medicinal products

(1) The professional prerequisite for the performance of qualified persons manufacturer
properly completed your studies, providing higher education
including at least four years of theoretical and practical training in one of the

Following areas of education:

A) pharmacy ^ 31)

B) general medicine, dental medicine or dentistry ^ 31)

C) veterinary medicine or veterinary hygiene and ecology

D) chemistry, or

E) Biology.

(2) The professional prerequisite for the performance of qualified persons manufacturer
may be studying in a degree program that provides university education
under paragraph 1, a minimum of 3 and a half year after studying
followed by a period of theoretical and practical training lasting
least one year and including a training period of at least six months in a pharmacy open to the public
, confirmed by an examination at university level
.

(3) If the European Union there are 2 study in degree programs
providing university education ^ 66), or study in 2
degree programs that are relevant Member State recognized as equivalent
, and if one of them has a standard duration of 4 years and the other 3
years, fulfills the condition set out in paragraph 2
study with the standard duration of study three years, leading to a higher education diploma, certificate or similar document
delivered in the proper completion of university studies
or its recognized equivalent if they are university diplomas,
certificate or other evidence of qualifications awarded upon graduation
both courses are recognized nationally
equivalent.

(4) The course shall include theoretical and practical tuition
least the following basic subjects:

A) experimental physics,

B) general and inorganic chemistry

C) organic chemistry,

D) analytical chemistry,

E) pharmaceutical chemistry, including drug control,

F) general and applied medical biochemistry,

G) physiology,

H) Microbiology

I) Pharmacology

J) Pharmaceutical technology

K) toxicology,

L) pharmacognosy, which includes teaching composition and effects of natural
active substances of plant and animal origin.

(5) The extent of the courses listed in paragraph 4 must enable the person
fulfill the obligations specified in § 66. If the qualifications of qualified persons
producer does not meet the above requirements can be under the control of the manufacturing authorization
her competence to perform the duties of a qualified person
manufacturer show another alternative way to assess
Institute or the Veterinary Institute.

(6) The qualified person of the manufacturer must have completed at least two years experience
1 or more manufacturers of medicinal products in the areas

A) qualitative analysis of medicinal products

B) quantitative analysis of drugs and

C) testing and checking necessary to ensure the quality of medicinal products
.

Duration of this professional experience may be reduced by one year if the standard
study period referred to in paragraph 1 is determined by the study program
at least 5 years and 18 months if the standard duration of study
program established at least 6 years.

§ 66

Responsibilities of the qualified person of the manufacturer of medicinal products

(1) A qualified person of the manufacturer is obliged to ensure that

A) each batch of product that producer was made and
controlled in accordance with this Act, the registration dossier and
the marketing authorization of a medicinal product

B) in the case of medicinal products coming from third countries, irrespective
whether this product has been manufactured in the European Union, it was his
each production batch has undergone in the Czech Republic, a full qualitative analysis,
quantitative analysis of at least all the active constituents and all the other
tests or checks necessary to ensure the quality of medicinal products
in accordance with the conditions of registration of the relevant medicinal product
;

If batch of product was subjected to controls to the extent
provisions of subparagraph a) or b) in a Member State and are available
the control reports signed by the qualified person of the manufacturer, then
such lot is exempt from inspections .

(2) In the case of medicinal products imported from a third country if the
European Union made with the exporting country appropriate arrangements to guarantee that
pharmaceutical manufacturer applies standards of good manufacturing practice
least equivalent to the standards set by the European Union and that checks
referred to in paragraph 1. b) were carried out in the exporting country,

QP of the manufacturer is obliged to carry out such checks.

(3) The qualified person of the manufacturer must certify in a register or
equivalent document provided for that purpose, that each production batch
complies with the provisions of paragraphs 1 and 2; said register or equivalent document
must be continuously updated according to the activities and
must be kept for at least five years.

(4) In the case of the manufacture of medicinal products used as rated
human medicines in clinical trials qualified person
manufacturer of medicinal products to ensure compliance with good manufacturing practice
prescribed by this Act and in accordance with the documentation submitted in
within the clinical trial application. The implementing regulation lays down the scope of control
evaluated for human medicines for imports from third countries and
procedure for their dismissal.

(5) In the event of a public health emergency due to violation
qualified persons manufacturer Institute or the Veterinary Institute shall give notice
under a special legal regulation 67) and shall immediately notify the manufacturer
medicines and qualified person in question the manufacturer that the manufacturer
qualified person not until the proceedings in this matter continues to perform activities
qualified person of the manufacturer.

§ 67

Transfusion service

(1) For the manufacture of transfusion products and raw materials for further production
consider all activities leading to the formation of a blood product or
raw materials for further manufacture. For production is also considered
distribution of transfusion products and distribution of raw materials for further production, including
distribution realized between the Czech Republic and another Member State.

(2) Transfusion products and raw materials for further production are authorized
produce only health service providers, whereby this activity allowed
Institute. Manufacturing authorization for transfusion products and
raw materials for further manufacture shall be issued after verification of the eligibility of the applicant
follow quality and safety standards set by law.
Application for authorization to manufacture transfusion products and raw materials for further manufacture
must contain data about the applicant as well as data specifying the subject
application and its justification. The implementing legal regulation stipulates the scope
application data and define the scope of quality and safety standards at
manufacture of transfusion products and raw materials for further manufacture.

(3) authorizing the manufacture of transfusion products and raw materials for further manufacture
apply § 63 accordingly. The Institute may allow
transfusion services in justified cases, to have
certain activities within manufacturing or control others. If this is
activities leading to the establishment of a transfusion product and raw material for further production and
persons conducting these specified activity within manufacturing or control
operate in the Czech Republic shall be such persons manufacturer
medicines, equipment or transfusion service
control laboratory. Responsibility Submitter
transfusion services in this case remains intact. If this is the distribution
transfusion product and raw material for further production device
transfusion service may arrange such distribution also other persons than the manufacturer
. In this case, the contract for the right to check
such person to comply with the requirements of this Act.

(4) The operator of a blood center must fulfill the obligations specified in §
64 point. d), e), h), i) and j), and is additionally required

A) to secure the services of a qualified person of the transfusion service by
paragraphs 6 and 7

B) ensure that minimize the risk of transmission of communicable diseases
human blood,

C) ensure that the manufacturing processes used in the manufacture of transfusion
products and raw materials for further production are validated in accordance with
good manufacturing practices and ensure consistency between
different preparations of the same type | ||
D) keep a sample of each donation of blood or its components,

E) keep and maintain documentation and records

F) establish a system for identifying donors, each subscription
each type and each individual unit of transfusion medicine and
raw materials for further production, including fulfillment of the requirements for their designation;

Establish a system for keeping track of donors, donations and individual
units of transfusion products and raw materials for further production method
ensure traceability of the origin and use of individual units
transfusion product and raw material for further processing and data about them

G) notify customers transfusion product and raw materials for further manufacture
additional findings of fact, which may cause serious adverse reactions
or are assessed as a serious adverse event
or suspected serious adverse event, and if
recipient is exposed to the risk of health hazards from already administered blood product transfusion and
notice does not provide medical service provider, also ensure
informing the recipient

H) establish and maintain a system for monitoring and evaluation of adverse events
and adverse reactions, accidents and errors, including a procedure allowing
if necessary, take all available measures
designed to ensure redress and to limit the adverse effects
transfusion product at the lowest possible level which would also include a procedure for withdrawal
transfusion product and raw materials for further manufacture of
further use

I) ensure that the scope and manner specified by the implementing legal
regulation and in accordance with the guidelines of the European Union

First traceability data on blood or blood components, their collection,
transfusion products and raw materials for further production

Second Information to be provided to donors of blood or its components

Third information which must transfusion service
obtained from donors of blood or its components, including their identity, history and signing
donor

Fourth assessing the eligibility of donors of blood and its components and testing
donated blood and its components, which include the criteria for permanent exclusion
and possible exceptions to these criteria and the criteria for temporary
exclusion

Fifth storage, transport and distribution

6th quality and safety of transfusion products and raw materials for further
production

7th meet the requirements for the production of blood products
made of pre-donated blood or blood components intended for a person filing
donor (autologous transfusion medicine)

8th meet the requirements relating to the system of quality assurance and good manufacturing practice
transfusion service,

J) advance for each calendar year a report on the activities of the Ministry of Health
,

K) remove blood products only from another transfusion
services and distribute blood products only
transfusion services and blood banks; this provision shall not affect the repayment
transfusion of blood bank

L) with respect to blood products, fulfill the obligations specified in § 83 paragraph. 6
point. a) and b);

Implementing legal regulation stipulates the scope of sample storage, scope and
method of recording and storing documents and records, the extent and manner
donor identification, collection and transfusion medicine, extent and manner
record keeping to ensure traceability scope and method of notification
customers by letter g) the method of transmission activity reports, scope and timelines
data transmission by the letter j) method of collection and distribution
transfusion product referred to in subparagraph a).

(5) The operator of a blood center, which holds
authorization pursuant to paragraph 2, is entitled

A) use and store under conditions stipulated by a special legal regulation
^ 36) personal identification number of the donor, who has collected blood or blood component
, for the purposes set out in § 24 para. 2

B) on the basis of consent pursuant to § 24 para. 4 Remove the transfusion medicine
equipment from a Member State that is authorized to perform the functions
by the competent authority of that State, and ensure distribution
blood product transfusion in Czech Republic or supply;
prior to such distribution or dispensing a qualified person dehydrating equipment
transfusion service verifies that the requirements have been met
equivalent to the requirements of this Act; unless these requirements are met, the device
transfusion service transfusion product must not distribute or issue;
Implementing legal regulation stipulates the scope and method of such verification,

C) in the case of urgent and immediate need to ensure
transfusion medicine to provide medical services to individual patients;

Condition for dispensing the consent of qualified person
transfusion service and the attending doctor granted after the risk assessment
benefit for the patient, and if it allows the health status of the recipient
transfusion product, also his consent;
implementing regulation lays down the method of issuing such approval,

D) take human blood plasma to produce medicines
containing anti-D immunoglobulin only from donors who have naturally
formed anti-D antibodies; these donors can be carried out any
additional immunization to increase the concentration of such antibodies;
artificial immunization in order to induce the production of anti-D antibodies in people who do not
naturally produced anti-D antibody is prohibited;
take blood plasma containing anti-D antibodies or additionally immunize can only
transfusion services they bled.

(6) The professional prerequisite for the exercise of the function of the qualified person
transfusion service is properly completed university studies that
provides higher education, including at least four years of theoretical and practical training
in pharmacy ^ 31) general medicine ^ 31)
biochemistry or biology and at least 3 years of professional experience, including two years in
transfusion service or blood bank.

(7) The qualified person of the transfusion service is obliged to ensure order


A) the collection, testing and processing of each unit of blood and its components
further control, release, storage and distribution of each unit
transfusion product, including a transfusion product distributed
within the European Union, imported from a third country or exported to a third country
, and each unit of raw material for further production in line with this
law

B) Institute is notified of serious adverse events and serious adverse reactions
or suspected; the adverse events and
adverse reactions were evaluated and carried out
all available measures to reduce the adverse effects of the transfusion medicine and
raw materials for further production including their possible withdrawal from further use
; implementing legal regulation stipulates the scope and nature of such
notice

C) compliance requirements for employees, documentation and records system
quality and good manufacturing practices and on the identification and traceability
each donor, each and everyone of its collection and transfusion medicine
raw materials for further manufacture including their purchasers and recipients.

(8) Certain activities of the qualified person of the transfusion service
under paragraph 7 may carry other people, by training and practice
qualified to perform their activities without the qualified person
transfusion services exonerated Liability under paragraph
7th Transfusion service shall inform the Institute name, or names and surnames
qualified person pursuant to paragraph 4. a)
and other persons under the previous sentence, as well as information on specific activities for which these persons
match. If any of these persons temporarily or permanently
replaced, the transfusion service shall forthwith communicate to the Institute
name a new person and the date when he takes up his position.

(9) In case of serious breach of the obligations of qualified persons referred to in paragraph 7
point. a) shall apply the provisions of § 66 para. 5th

(10) The authorization to manufacture transfusion products shall also be required for imports
transfusion products from third countries. In the case of imports
transfusion product from a third country, the qualified person of the transfusion service
importing transfusion service checks that
for the collection and production of the imported transfusion product were met
requirements at least equivalent to the requirements of this Act;
implementing legal regulation stipulates the scope and method of verification.
Transfusion product from a third country nedoveze if the requirements are not met
previous sentence and was given approval by the Ministry of Health according to § 24 paragraph
. 4; except in the case of urgent and immediate need to ensure
transfusion product for the provision of health services to the patients
when a condition for imports from third countries, the consent
qualified person and the attending doctor granted after evaluating the risks and benefits for the
patient, and if it allows the health status of the recipient

Transfusion product, also his consent;
implementing regulation lays down the procedure for issuing such permission.

(11) The operator of a blood center is authorized to issue
transfusion products. The procedure and method of dispensing of transfusion products
in the implementing legislation.

§ 68

Provider of medical services with the blood bank

(1) The provider of health services, which includes blood bank is obliged


A) ensure compliance with the requirements for the quality system and good manufacturing practice
, including in particular staff training, security management
documentation and processes and maintaining the material conditions of operation, and
requirements for activities conducted blood bank in accordance with this
law

B) perform in scope to the blood bank requirements specified in § 67 para. 4
point. e) to h) and points. i) points 1 and 5-8 and a point. j) similarly

C) to secure the services of a qualified person of a blood bank,

D) within 15 days to notify the Department of commencement and termination of
blood bank that is part of it.

(2) The professional prerequisite for the performance of qualified persons
blood bank is duly completed a four-year university study that provides
higher education including at least four years of theoretical and practical
teaching in the field of pharmacy ^ 31) general medicine ^ 31)
biochemistry or biology and at least one year of professional experience in the transfusion service or blood bank
, is responsible for the operation of blood banks in accordance with this Act
.

§ 69

Control laboratory

(1) The control means a laboratory verifies the quality of medicinal
products, active substances, excipients, intermediates or packaging
including partial testing.

(2) control laboratory is subject to authorization
Institute or the Veterinary Institute at the request of the natural or legal persons.
The application must contain data about the applicant, data on the subject of the application and its justification
. The implementing legal regulation stipulates the scope of these data. For
licensing control laboratory for change
this authorization and to cancel the provisions of § 63 para. 1 point. c) and
paragraph. 2-9 likewise with the fact that the provisions concerning the qualified person is
apply. If it is a manufacturer of medicinal products includes permission to manufacture and
permission of the manufacturer to inspect.

(3) The operator of a control laboratory must fulfill the obligations specified in §
64 point. b), d), e), i), j), q), r) and x).

(4) The operator of a control laboratory is required to apply in advance
Institute or the Veterinary Institute to amend permits control laboratory
in the event of any imminent change in the data compared to data submitted under paragraph 2


Responsibilities of the importer, manufacturer and distributor of medicinal substances

§ 69a

(1) Importers, manufacturers and distributors of medicinal substances intended for use in
human medicines, have their registered office or place of business
or organizational unit in the Czech Republic, the Institute shall notify its
activity, not later than 60 days before the intended commencement of operations.

(2) The notification submitted by the persons referred to in paragraph 1 of a form which
published by the Institute in its information media.

(3) Department after the notification referred to in paragraph 1
assess the risk associated with the reported activities and on this basis may decide to carry out an inspection at
notifier. If the Institute inform the notifier
within 60 days of receipt of the notice, it will be inspected by the notifier
activity will not start until the notifier informs the Department that he may commence.
If the Institute informs the notifier within 60 days of receipt of notice
to be inspected, a developer can launch this activity.
Activities of the notifier may commence even if no inspections carried out by the Institute
date specified in the communication pursuant to the second sentence, or if not
if within 60 days of the inspection communicated to the notifier its outcome
.

(4) The notifier is required to annually disclose Institute
any changes regarding the information included in the notification. Any changes that may have
affect the quality or safety of drugs that are manufactured, imported or distributed
notifier shall forthwith communicate to the Institute.

§ 69b

For manufacturers of active substances intended for use in veterinary medicinal

Preparations applies to § 78 par. 2 and 3, mutatis mutandis.

§ 70
Heading left


(1) Except for GMP for active substances specified in an implementing regulation
a manufacturer of active substances required to follow the
Commission and the Agency in this field. Compliance with the requirements of good manufacturing practice for medicinal
substances is evidenced by a certificate of good manufacturing practice for manufacturers
drugs. Certificate of Good Manufacturing Practice for
manufacturer of active substances shall Institute or the Veterinary Institute; in the event that
directly applicable legislation of the European Union or Commission guidance states
different requirements for the production of medicinal substances intended for use in
medicines for human and veterinary medicinal products
certificate of good manufacturing practice for manufacturers drugs issue
Institute or the Veterinary Institute.

(2) imported from third countries can only such active substances intended for use in
medicinal products which have been manufactured in accordance
with good manufacturing practice for medicinal substances
least equivalent to the standards established by the Commission and which are accompanied by documentation, to
which is connected to the relevant authority of the country in which the active substance is manufactured
mainly comprising

A) certification, good manufacturing practice for medicinal substances of the country in which the active substance
been made, at least equivalent to the standards established by the Commission
, b) attestation that the manufacturer of the drug substance and the place of manufacture
subject to regular, strict and transparent controls and
effective enforcement of good manufacturing practice, including repeated and unannounced inspections
, which ensures the protection of public health
least equivalent to that in the European Union, and

C) a statement that such authority shall immediately inform the Agency
in the event that it finds that the conditions for issuing the certificate
according to a) or b).

(3) The provisions of paragraph 2 shall not affect the obligations of the manufacturer of the medicinal product
according to § 26 and § 64 point. l).

(4) confirmation by the competent authority pursuant to paragraph 2 shall not be required if
country in which the active substance is manufactured, registered on the list of third countries
issued by the Commission, for which the level of public health protection || | deemed equivalent level of protection in the European Union.

(5) In exceptional cases, if it is necessary to ensure the availability
medicines, and if it was the manufacturer of the active substance, after
inspection of the factory, issued by a competent authority of a Member State
certificate of good manufacturing practice for medicinal substances, the Institute
decide that a manufacturer may not have the certificate pursuant to paragraph 2,
maximum period of validity. The use of this option shall inform the Commission
Department.

(6) Distribute the active substance can only be in accordance with good
distribution practices for active substances laid down by Commission guidelines.

Requirements for the manufacture, prescription and use of veterinary autogenous vaccines


§ 71

(1) For the production of veterinary autogenous vaccines, the provisions of §
62 to 66 for the manufacture of medicinal products accordingly.

(2) Veterinary autogenous vaccines are manufactured and supplied to veterinary doctors
based on its issued prescription.
Implementing legislation establishing the terms prescription for the manufacture of veterinary autogenous vaccines issued
veterinarian (hereinafter "prescription for veterinary autogenous vaccines
") and conditions for handling
veterinarians and producers. Batches of veterinary autogenous vaccines with
means the amount of vaccine produced in accordance with a prescription for veterinary
autogenous vaccines.

(3) Veterinary autogenous vaccines may prescribe, produce or place
into circulation only for the purpose of addressing the current health situation in particular
herd in the area and provided that the solution to this situation is not
There is no effective authorized veterinary immunological medicinal
preparation which contains any pathogen or antigen contained in
veterinary autogenous vaccine.

(4) Veterinary autogenous vaccines may be made entirely of
pathogens and antigens obtained from an animal or animals from a breeding
in one location and to isolate manufacturer of medicinal products.

(5) pathogens or antigens obtained and isolated in accordance with paragraph 4

Possible the manufacture of veterinary autogenous vaccines for
maximum period of 6 months from their collection, unless the competent
manufacturer of veterinary autogenous vaccines by checking that repeats
always within 6 months of the previous examination that pathogens or antigens may
view of the current disease situation in the herd
continue production of autogenous vaccines for use.

(6) Prior to the commencement of production of each batch of veterinary autogenous vaccines
a manufacturer submits a notice of commencement of production
Veterinary Institute and regional veterinary administration in whose jurisdiction includes the following
vaccine used. The notification must contain data about the applicant, data on the subject
notification and justification. The implementing legal regulation stipulates the scope of data
this announcement.

§ 72

(1) The manufacturer of veterinary autogenous vaccines shall ensure that
veterinary autogenous vaccines were identified in the internal and, if
present, even on the outer packaging information to ensure safe use of veterinary autogenous
vaccine in the respective breed. Each pack
veterinary autogenous vaccines must be attached leaflet;
This does not apply if all the information that must be included in
leaflet, listed on the inner cover
veterinary autogenous vaccine. Veterinary autogenous vaccines shall only be used in
accordance with the information on the package or leaflet
autogenous vaccine. The implementing legal regulation stipulates the scope of data declared
packaging of veterinary autogenic vaccines and requirements for the structure and content
leaflet.

(2) Before using veterinary autogenous vaccine, the competent
veterinarian perform a compatibility test on the target animals
in accordance with the instructions on the package or leaflet
veterinary autogenous vaccine.

(3) May not be used in veterinary autogenous vaccines

A) which thus ruled Veterinary Institute or considering
veterinary measures adopted under a special legal regulation 18)
competent authority veterinary supervision

B) a quality defect,

C) use expired or

D) they have been kept under conditions other than those laid down their
manufacturer.

(4) The manufacturer of veterinary autogenous vaccines is obliged to report
Veterinary Institute within 30 days of receipt of the information
suspected quality defect or suspected adverse
effects associated with the use of its manufactured veterinary autogenous vaccine ;
It does not apply if already on the suspected quality defect or suspected
of adverse reaction demonstrably informed by the attending veterinarian
Veterinary Institute.

(5) The attending veterinarian is required within 15 days to report
manufacturers who produce veterinary autogenous vaccine,

A) of suspected quality defects of veterinary autogenous vaccines or

B) of suspected adverse reactions associated with the use
veterinary autogenous vaccine.

Special rules for the production, marketing, prescription and
use of medicated feed.

§ 73

(1) Medicated feed may only be constructed of medicated premixes and
put into circulation only on prescription issued by a veterinarian
(hereinafter "prescription for medicated feed") and in accordance with
permit the manufacture of medicated feed.
Prescription for medicated feed must be issued in accordance with the conditions set
in the marketing of the medicated premix.
Batches of medicated feed means a quantity of medicated feed produced
on a veterinarian's prescription or in one production cycle.
Every batch of medicated feed imported from a third country must be
Czech Republic controlled in accordance with the conditions laid down in
manufacturing authorization for medicated feeds.

(2) For the manufacture of medicated feeds the provisions of this Act
for the manufacture of medicinal products similarly, except the educational requirements
qualified persons manufacturer of medicated feeds and their activities by
§ 65 and import requirements medicated feed from third countries.

(3) Medicated feed may be distributed from Member States only on the basis
prescription for medicated feed and in accordance with the requirements of § 74 paragraph
. 9 to 12


(4) The manufacturer of medicated feeds is required in case of contract manufacturing or control of medicated feed
carried

A) the third country to submit to the Veterinary Institute
certificate issued by the competent authority of the third country, which proves that
place of manufacture or control of medicated feed is authorized by the competent authority and that
checked regularly, and or other documents which will prove
conditions under which they are medicated feed manufactured or controlled

B) in the Member State to ensure that medicated feeds are manufactured or
checked in accordance with European Union regulations and submit
Veterinary Institute certificate issued by the competent authority of the Member State
that manufacturers of medicated feed is valid
authorization for manufacture of medicated feed by the competent authority of a Member State.

(5) The manufacturer of medicated feeds in the case of contract manufacturing or
control of medicated feed also obliged to provide the inspectors
Veterinary Institute, arise any doubt about the fact that
medicated feeds are manufactured or controlled in accordance
this Act, possibility of carrying out checks at contract manufacturing or
control of medicated feed.

(6) The manufacturer of medicated feeds is entitled to subcontract part of their production
another person, and its liability for damages remains unaffected.

(7) The manufacturer of medicated feeds must also ensure that

A) medicated feed is produced or put into circulation in accordance with the conditions laid down in
prescription for medicated feed exposed
according to § 74 para. 1-3,

B) the manufacture of medicated feeds are used for animal feed or
combinations that are in compliance with the requirements laid down by special legislation
^ 68)

C) used in feed creates the relevant medicated premix
homogeneous and stable mixture

D) medicated premix in the manufacture of medicated feeds
used in accordance with the authorization and that

First excludes any undesirable interaction between the medicated
premix, additives ^ 68) ^ 68 or feed)

Second medicated feed keeps its properties for a specified period
usability

Third feed, which is used for the manufacture of medicated feed does not contain the same antibiotic or
anticoccidicum, as the drug is contained in the relevant
medicated premix.

(8) If the requirements of paragraph 7, the manufacturer of medicated feeds
medicated feed manufactured or put into circulation.

(9) The qualified person of a manufacturer of medicated feeds must have

A) university education in an accredited master's study program
pharmacy under a special legal regulation 31)
accredited master's degree program in veterinary medicine or in
accredited master's degree program in veterinary hygiene and ecology
, accredited healthcare master's study program
general medicine, dentistry, dentistry, agriculture
biological or technical disciplines, biology or chemistry

B) 2 years professional experience in the manufacture or control of pharmaceuticals and specialized
completion of the course; implementing legal regulation stipulates the scope
specialized course; practical and theoretical experience is
qualified person is required to complement the light of the current state
scientific knowledge and technological progress; relevant manufacturer is required to create
qualified person of a manufacturer of medicated feeds
conditions for further education.

(10) The Qualified Person responsible manufacturer of medicated feeds

A) that each batch of medicated feed is produced and controlled
in accordance with this Act and that it is made in accordance with the conditions set out in
Holder of the medicated premix

B) in the case of medicated feeds coming from third countries that
the batch of medicated feed on the territory of the Czech Republic
controlled in accordance with the conditions stipulated in the license to manufacture.

§ 74

(1) The prescription for medicated feed provides
attending veterinary surgeon who issued the prescription, the method of placing medicated feed
into circulation pursuant to paragraph 7. A prescription for medicated feed
valid for a maximum period of 14 days from its date of issue. Manufacturing medicated feed or
putting it into circulation to a prescription for medicated feed is not

Repeated. The implementing legal regulation stipulates the method, requirements on the content and
breakdown prescription for medicated feed, the number of copies of this
regulation and handling.

(2) prescription for medicated feed should be drafted so that a daily dose
medicated premix is ​​contained in the amount of feed that
corresponds to at least half the daily ration treated animals
if the medicated premix is ​​mixed with feed, or in the case of ruminants
least half the daily requirement of non-mineral supplementary feeding
if the medicated premix is ​​mixed with neminerálními supplementary feed.

(3) Before issuing a prescription for medicated feed should appropriate
attending veterinarian to make sure that the administration of the medicated feed
is not incompatible with a previous treatment and, if it is in the manufacture of medicated feed
use more than a medicated premix that among them
no undesirable interactions.

(4) The competent attending veterinarian may prescribe
medicated feed only in an amount which is necessary to address the specific situation
treated animals; duration of administration of the medicated feed
not exceed the period specified in the marketing authorization
medicated premix used for manufacturing medicated feed.

(5) Medicated feed according to the nature of the feed
called in accordance with the requirements laid down by special legislation 68).
Implementing regulation provides extra information on the packaging
medicated feeds. These data are presented in Czech language.

(6) In the case of medicated feeds put into circulation in containers
bulk materials data in accordance with paragraph 5
listed in the documents that accompany the medicated feed.

(7) Medicated feed are authorized to circulate
manufacturers of medicated feed, in the case of feed produced by them, and distributors with
permit distribution of medicated feeds and deliver them in accordance with regulations
for medicated feed

A) attending veterinarian who issued the prescription for medicated feed
solely for subsequent use by veterinary
doctor or

B) the breeder mentioned in the prescription for medicated feed.

(8) Medicated feed may be placed on the market only in sealed original packaging
which are secured so that they can be opened
remain wrappers or containers in the case of bulk materials to ensure their
permanently , and apparently irreversibly damaged.

(9) For imports of medicated feed from third countries
the provisions of this Act relating to the manufacture of medicated feeds similarly.

(10) from Member States to the Czech Republic can only distribute
medicated feed that was produced in the European Union by persons
have a valid permit to manufacture medicated feeds
in the Member State that It was made in accordance with the requirements set out in
prescription for medicated feed issued by the competent
attending veterinarian; In this case, prescribed by the competent veterinary doctor
medicated premixes registered in the Member State where the
medicated feed manufactured, whose composition corresponds
medicated premixes registered in the Czech Republic, or medicated premixes
registered under directly applicable regulation EU-24).

(11) Medicated feed distributed from Member States must meet the requirements for feed
set special legislation 68) and
must be accompanied by an accompanying certificate issued by the competent control
authority in that Member State and the relevant regulations
for the medicated feed in accordance with the requirements of paragraph 1

(12) A person who distributes the Czech Republic medicated feed, medicated feed
adds only a person who is a recipient of the medicated feed
listed in the relevant prescription for medicated feed
pursuant to paragraph 1. Amount
medicated feed distributed from Member States must comply with the relevant
prescription for medicated feed. The certificate referred to in paragraph 11 stores
person to whom the medicated feed supplied for a period of 3 years from delivery
medicated feed and a copy sent within 7 working days
Veterinary Institute and the respective regional veterinary administration.

(13) When the conditions set out in paragraphs 11 and 12,

Orders Veterinary Institute suspension of the application or removal of the medicated feed
. Costs associated with the removal
paid by the owner of the medicated feed.

(14) In the case of distribution of medicated feed to other Member States
where the competent Member State requires that accompanied the manufacturer or distributor
medicated feed to the shipment of medicated feed
certificate issued by the Veterinary Institute at the request of the manufacturer
or distributor, which proves that the relevant medicated feed was manufactured
person who has been issued a permit for the manufacture of medicated feeds
in accordance with the requirements laid down by European Union law.

(15) Feed used in the manufacture of medicated feeds
subject to veterinary supervision by special legislation 18).
Section 2


Distribution of medicines and their mediation

§ 75

Basic provisions on the distribution of medicines and their mediation


(1) Distributed may be medicinal products

A) registered in accordance with this Act,

B) not registered under this Act unless

First They are registered in accordance with European Union law
competent authority of another Member State; These medicines, however, must
put into circulation in the Czech Republic, except for supply to pharmacies that have
certificate for mail-order dispensing abroad

Second their distribution is possible under § 49 within
therapeutic programs or pursuant to § 8. 6

Third their prescribing or use is permitted pursuant to § 8. 3-5, while
meet the conditions set out in § 77 par. 1 point. i), or

Fourth their use in veterinary care has been authorized by
§ 46-48, and the limits imposed by the competent authorities.

(2) Distributor may, or through other distributors
supply medicinal products, in the case of medicinal products pursuant to paragraph 1
point. b) points 2-4, operators authorized pursuant to § 82 para. 2
medicines issue. The Distributor may also
supply medicinal products, in the case of medicinal products pursuant to paragraph 1. b) paragraph 3
operators authorized to use medicinal products in
provision of health services, and in the case of medicinal products pursuant to paragraph 1.
B) point 4 of veterinarians authorized to engage
professional veterinary activity according to legal regulation 18).
Implementing legal regulation stipulates the method of ensuring good distribution practice for parallel import
, therapeutic programs and other cases
distribution of unregistered medicines and distribution of promotional samples of medicinal products
well as the method of providing medicinal products for humanitarian
help.

(3) medicines are authorized to distribute persons to whom this
activity was authorized by the Institute or the Veterinary Institute (hereinafter
"distribution authorization"). Operators authorized to dispense medicinal products
can distribute them only if they get permission to distribute
.

(4) The holder of a distribution authorization granted by the competent authority of another Member State
in the Czech Republic the same rights and obligations as
distributor pursuant to paragraph 3. The holder of the authorization for distribution
has an obligation to give prior notice to the Constitution or Veterinary Institute launch
distribution in the Czech Republic, document distribution authorization
issued by another Member State to provide the data required to ensure
cooperation with him and further information on the extent and location of distribution
distribution warehouses. If the holder of the authorization for distribution in the Czech Republic
establishes distribution warehouses for distribution in the Czech Republic or part
negotiate distribution consisting of storing in the Czech Republic at
another person who is not a distributor, then it is covered by the obligation
prior permission to distribute the Institute or the Veterinary Institute.

(5) The manufacturer of medicinal products is authorized to perform activities
distributor in compliance with the terms of this Act, in the case of medicinal products
which manufactures or imports from third countries.
This authorization also applies to holders of manufacturing authorization granted by the competent authority
another Member State, the provisions of paragraph 4, it is subject
analogy.

(6) The permit to distribute the indication approved storage

Space in the Czech Republic, for which it is valid;
Part of the authorization may also be setting conditions for the exercise
distribution, including its scope. The distribution authorization does not constitute
qualified for any manufacturing activity in the field of medicinal products
if it was not for the activity permit to
production.

(7) Permission to distribute does not constitute authorization to provide
imports of medicinal products from third countries unless such import permits issued
production.

(8) The Institute or the Veterinary Institute shall provide the Commission or the competent authority of the Member State
at their request, any information concerning individual
distribution authorization. If the Institute or the Veterinary Institute
suspend distribution authorization or the consent,
shall forthwith inform the Commission and the competent authorities of the Member States.

(9) Where the Institute or Veterinary Institute considers that the conditions of authorization to distribute
issued by the competent authority of another Member State
not or are no longer met its holder, it shall immediately inform the Commission and the relevant
Member State authority.

(10) If the Institute or Veterinary Institute is informed by the Commission or
Member State competent authority that the permit conditions for distribution
issued by the competent institution are not or are no longer fulfilled distributor,
take necessary measures in accordance with this law and inform the Commission and
relevant Member State authority on these measures and the reasons for them.

§ 76
Permitting distribution


(1) An authorization for distribution shall be issued if the applicant meets the following requirements:

A) have suitable and adequate premises, installations and equipment in order
ensure proper storage and distribution of medicines,

B) has secured the services of persons who fulfill the conditions laid down by
law, and the services of a qualified person who is responsible for ensuring that medicinal products
, or even the active ingredient and excipients in accordance with the scope of the authorization
for distribution are distributed in accordance with this Act;
Professional prerequisite for a qualified person is
graduation in an accredited healthcare masters study program in pharmacy
under a special legal regulation 31) or
accredited healthcare masters study program in general medicine ^ 31)
or dental-31) or an accredited master's degree program
veterinary medicine or
accredited master's degree program in veterinary hygiene and ecology or in
chemistry or biology,

C) demonstrates that it has the potential to fulfill the obligations pursuant to § 77

(2) The procedure for permission to distribute the provisions of § 63 para. 1 to 5 and 7
similarly that a qualified person applies
requirements under paragraph 1. b). The implementing legal regulation stipulates the scope of data
application for distribution authorization.

(3) Distributor is obliged to apply beforehand Institute or Veterinary Institute
to change the authorization for distribution in the event of planned changes compared
conditions under which the permit was issued. Permission to distribute
Institute or the Veterinary Institute shall suspend or revoke it fails to fulfill distributor
conditions specified in the license to distribute or seriously violated
obligations stipulated by this law.
Institute or the Veterinary Institute shall suspend the authorization for distribution in those cases where the information obtained
incomplete or such shortcomings are identified which are removable
nature. The Institute or the Veterinary Institute shall revoke the
distribution in those cases where the information obtained is incomplete or such shortcomings identified
not removable nature.
Permission to distribute Institute or Veterinary Institute also canceled at the request of
whom it was issued.

(4) If, for at least 3 years from the coming into force of permits
distributor fails to engage in distribution activities, authorization shall be valid for distribution
.

§ 77

The rights and obligations of distributors

(1) The distributor must

A) make the premises, installations and equipment used for the distribution
staff of institutions authorized to carry out tests

B) to take medicines only

First from another distributor,

Second from the manufacturer, and medicines, which the manufacturer produces or
imported

Third chemist returned to the pharmacy distributor added or


Fourth returned the doctor, whom the distributor of medicines supplied for the purpose of vaccination
under subparagraph c) item 13

C) distribute medicines, unless the export to a third country only

First persons who are distributors

Second persons who are authorized to issue medicines or
vendors of selected medicinal products, in the case of reserved
medicinal products

Third persons providing health services, in the case of gases used in
provision of health services or infusion, hemofiltration and dialysis
solutions

Fourth providers of health services in accordance with § 82 para. 2 point. f)
case of radiopharmaceuticals,

Fifth the device according to § 82 par. 2 point. c) in the case of immunological
preparations

6th veterinarians authorized to engage
professional veterinary activity pursuant to special legislation, 18), in the case of medicinal products for the treatment
animals

7th breeders, in the case of disinfectants and insecticides preparations determined
Veterinary Institute,

8th breeders who breed animals for slaughter and animals intended for food production
based on prescription attending veterinarian
physician authorized to perform professional veterinary activity pursuant
special legislation, 18), in the case of registered veterinary
Medicines

9th a marketing authorization holder, in the case of promotional samples of medicinal products
; Treatment with advertising samples subject to a special legal regulation
^ 51)

10th dealers authorized by the MAH,
case of promotional samples of medicinal products authorized by
holder

11th manufacturers of medicated feed, in the case of medicated premixes

12th equipment transfusion service or blood banks, in the case of
transfusion products and where such distribution of transfusion products
entered transfusion service facilities according to § 67 par. 3,

13th doctors, and only immunological products intended for vaccination, or

14th physicians who are directly used in the provision of health services,
and only medicinal products for advanced therapy

D) have an effective system to ensure the withdrawal of a medicinal product from circulation;
in the framework of this system, the distributor is obliged to provide information about defects
medicines and their side effects
notify all their customers, including vendors of selected medicinal products
which such product is distributed, and cooperate with the manufacturer | || relevant medicinal product and the marketing authorization holder,

E) maintain records that must be made available to the competent authorities for control purposes
over 5 years; implementing legal regulation stipulates the method and extent
maintain such records,

F) provide for the supply of medicinal products authorized
records supplied these products through their codes and store these records
after a period of 5 years; Distributor regularly provides the Department with complete and correct
data on the volume of medicines, which were distributed to pharmacies and other providers
health services, other distributors
vendors of selected pharmaceuticals and to veterinarians and the volume
advertising samples added marketing authorization holders or
sales representatives, and the veterinary Institute complete and correct information about
volume of medicinal products, which were distributed to pharmacies, veterinary
doctors, breeders and manufacturers of medicated feed;
range of data and how they are provided in the form of reports published by the Institute or
Veterinary Institute in its information media,

G) to observe the rules of good distribution practice, including requirements
securing the services of a qualified person on staff, premises,
technical equipment, documentation and system for downloading
medicinal products from the market and follow the instructions of the Commission and agencies; when
distribution follows the detailed instructions
Institute and the Veterinary Institute; implementing regulation lays down the rules of good distribution
practice

H) provide for Proprietary Medicinal Products, the distributor,
supply operators authorized to dispense medicinal products in quantities and
intervals corresponding to the needs of patients in the Czech Republic;
Implementing regulation establishes requirements for the amount and timing

Intervals, or their relationship for the supply of medicinal
products to meet the needs of patients

I) in the case of imports of medicinal products from a third country that is not
registered in any of the Member States nor the European Union,
conducted pursuant to § 8. 3-5, to import up to release | || consent of the Institute this import based on demand; this does not apply
if the import of such medicinal product approved for therapeutic
program will take place pursuant to § 8. 6; Department issued approval,
if the available information on the safety, efficacy and quality of medicinal product
do not prove sufficiently favorable ratio of benefit to risk
a medicinal product; request must contain information about
applicant's medicinal product manufacturers and providers
appropriate health services; implementing legal regulation stipulates the scope of these
data; in the case of imports under this paragraph, the provisions of § 66 para. 1
point. b) and § 75 para. 7 not used,

J) if the medicinal product is obtained from another distributor, to verify whether the distributor
compliance with good distribution practices

K) if the medicinal product is obtained from the manufacturers of medicinal
product, verify that a valid permit to manufacture,

L) if the medicine gets mediation, verify that
intermediary meets the requirements laid down in this Act,

M) verify that received human medicines are not falsified
checking the safety features on the outer packaging by
directly applicable regulations of the European Union or Commission guidelines

N) create and maintain an effective quality assurance system, which
out responsibilities, processes and risk management measures in connection with his activities
,

O) promptly inform the Institute and holder of the marketing authorization for the medicinal product
who received or was offered and on which
found that it is a counterfeit human medicine, or who is suspected
,

P) if the medicine is taken from a person from a third country or
to a person in a third country to verify whether the person is authorized to collect or deliver
Medicinal Products under the regulations of the country
.

(2) Distributor is authorized to contract out part of the wholesale distribution of medicinal products
with another person, and its liability for damages in such a case
remains unaffected. Distributor agrees to a contract right
check that person compliance with good distribution practices.

(3) Any delivery of the medicinal product to persons authorized to dispense medicinal products or sell
reserved medicinal products must be accompanied
documentation that allows for tracking the distribution of medicinal
product. This documentation contains information about the product, including
batch number, the supplier and customer medicinal product
delivery location and time data distribution, and to the extent set
implementing legislation. In the event that the medicinal product is taken
pharmacy operator, who is also the holder of a
distribution must be stated in the documentation, whether the customer takes
medicines as an operator of a pharmacy or a distributor.

(4) Distributor is obliged prior to the commencement of distribution of the active substance or excipients
persons authorized to prepare medicinal products or
gases used in the provision of health services to persons authorized
is used in the provision of health services, or human
blood and its components make an application to extend the scope of distribution authorization
Institute or Veterinary Institute. The Institute or the Veterinary Institute
expand the scope of distribution authorization permit
after verification that the conditions stipulated by this law.

(5) Distributor with a range of permits covering
distribution of medicinal substances and excipients, apart from the obligations specified in the distributor
paragraphs 1-3, further obliged

A) supply persons authorized to prepare medicinal products only such
medicinal substances and excipients whose quality is verified

First control laboratory with a range of activities for the control of drug substances and excipients
,

Second manufacturer in whose scope of activity is the control of medicinal substances and excipients
,


Third manufacturer of raw materials, who holds a valid certificate of good manufacturing practice
in the production of raw materials or

Fourth in the European Union in a manner that is at least equivalent
requirements for verifying the quality of medicinal substances and excipients
under points 1 to 3;

Persons referred to in paragraphs 1-3, the Institute or the Veterinary Institute
assign a registration number, which these persons are obliged to label them
issued certificates attesting to the quality of medicinal substances and excipients;
Implementing legal regulation stipulates the scope and method of verification according to clause
4

B) deliver the drug substance and excipients to persons authorized to prepare
Medicines manner stipulated by the implementing legislation,

C) have an effective system to ensure the withdrawal of the active substance or excipients
substances from circulation pursuant to paragraph 1. d) analogy.

(6) The scope of distribution authorization may also be based on an application submitted to the Veterinary Institute
extended
distribution of medicated feed. Distributor with a range of permits covering
distribution of medicated feeds in addition to the distributor obligations specified in paragraph 1
point. a), e) and g) further obliged to comply with the conditions for
medicated feeds into circulation according to § 73 and 74.

(7) In the event that a distributor who is not the holder of a
authorization for this medicine, intends to distribute
from another Member State to the Czech Republic medicinal products which have been granted pursuant
directly applicable
EU regulations governing the procedure for the authorization and supervision of medicinal products ^ 24)
is obliged to announce their intent by marketing authorization holders and
Institute.

(8) If the medicinal product is directly received from a third country, but it comes
goods granted in the Czech Republic, transit, not a
paragraph 1 point. b) and m).

§ 77a

Agents human medicines

(1) The subject of mediation can only be human medicines
registered under this Act or pursuant to a directly applicable regulation
European Union governing the procedure for the registration and supervision of medicinal products
^ 24).

(2) and mediates human medicines can only person who
is established in the Union, and is registered by the Institute or the competent authority of another Member State
.

(3) The Institute shall register the intermediary of a request under paragraph 4
, if the applicant meets the following requirements:

A) a natural person with a business or organizational component
enterprise in the Czech Republic or a legal entity established or
organizational part of the enterprise in the Czech Republic and

B) a trade certification in the field of activity brokering
services.

(4) An application for registration must include in addition to the general requirements
address space of intermediation in the Czech Republic and
contact information including name and surname of the contact person's telephone number and
e-mail address and identifier data clipboard.
The provider is obliged to immediately notify the Department of any change
data not reference data in the registry of persons.

(5) Department of registration within 30 days of receipt. About this
fact, notify the applicant without undue delay.
Authorization for medicinal products for human mediation arises applicant
entry in the register of intermediaries. If the applicant does not meet the requirements set out in paragraph 3
point. a) and b), the Institute shall reject the application.

(6) If the provider fails to comply with the requirements laid down in this Act or
Commission guidelines, the Institute may decide on his removal from the register
intermediaries.

(7) At the request of the mediator Department performs its deletion from the registry
intermediaries.

(8) The intermediary shall be subject to § 77 par. 1 point. d), e), f), g)
n) and) similarly.

§ 77b

List intermediaries

(1) The Institute establishes and maintains a publicly accessible register
intermediaries whose purpose is to register the persons authorized to carry
brokering medicinal products.

(2) The Institute shall publish content providers to register their
website.

(3) The register of intermediaries are processed such personal data
intermediaries who are natural persons:


A) the name or names and surnames,

B) identification number,

C) the address of the place of business,

D) the name and surname of the contact individuals, their telephone number and electronic mail address
.

(4) List brokers contain the following information about
intermediaries who are legal persons:

A) the name

B) identification number,

C) registered address,

D) the name and surname of the contact individuals, their phone number and
e-mail address.

(5) The data referred to in paragraph 3 or 4 in the registry
intermediaries processed for the duration of the mediation
human medicines.

§ 78

(1) Substances that have anabolic, anti-infectious, anti-parasitic,
inflammatory or hormonal action, or substances or
precursors, and which may be used for the manufacture of veterinary medicinal
products may merely retain people who use these substances for
activities in which they are authorized to dispose of such substances on
under this Act or under special legal regulations 69).

(2) Natural or legal persons who manufacture, import, export,
buying, selling, processing, transporting, storing, regulating or performs
further commercial operations with substances under paragraph 1, unless the activities | || authorized under this Act, irrespective of the fact whether it is a
activities performed for profit or for free, are required no later than the day
start of operations to give notice to the Veterinary Institute.

(3) The notification must include information on the notifier, on the location or locations where
activities are occurring under paragraph 2, on the substance or substances and
justification for action pursuant to paragraph 2. In the event of any change in | || reported data from the notifier Veterinary Institute without delay
complete, updated notifications. The implementing legal regulation stipulates the scope of data
notice.

(4) The persons referred to in paragraph 2 shall keep and maintain for at least 3 years
records of all business activities with the substances referred to in paragraph
first These records contain data on suppliers, customers, about the substance that is the subject
relevant business activity, timestamps and data
optional treatment substance. The implementing legal regulation stipulates the scope of records.

(5) The persons referred to in paragraph 2 shall allow the performance of the control
employees of the Veterinary Institute authorized to control and
provide them any assistance necessary to carry out inspections to the extent that
Veterinary Institute provides, including access to space , installation,
equipment or documentation related to the handling of substances pursuant to paragraph 2.


(6) Supervision over the handling of substances pursuant to paragraph 2
methodically coordinated by the Veterinary Institute. During these operations, working
Veterinary Institute and other state authorities, especially with the Institute and
customs authorities; concerned government authorities are obliged to provide
Veterinary Institute cooperate to the extent necessary.
Section 3


Preparation and presentation of medicines

§ 79

(1) Medicines can be prepared only

A) on the basis of a medical prescription for an individual patient,

B) in accordance with the Czech Pharmacopoeia, or

C) based on technological regulation processed by a person authorized to prepare
if prepared for a medicinal product is not listed
article in the Czech Pharmacopoeia; implementing legal regulation stipulates the content and method of processing
technological regulation.

(2) Medicines can be made only

A) a pharmacy

B) in the nuclear medicine healthcare providers,
case of radiopharmaceuticals, or

C) an immunological or microbiological workplace
providers of health services or healthcare providers
practicing under a special legal regulation 70), in the case of
human autogenous vaccines.

Implementing legal regulation stipulates the scope and method of preparation for
individual healthcare workplaces, including good pharmacy practice
.

(3) The provider of health services, which prepares medicines
under paragraph 2 is obliged to ensure the quality
prepared medicinal products in its activities follow the rules of good pharmacy

Practice; proceed in accordance with instructions detailing Institute published in its information media
.

(4) A legal or natural person operating a pharmacy (hereinafter
"operator of a pharmacy") shall within 15 days notify
commencement and termination of its activities of the Institute.
Provider of health services in accordance with paragraph 2. b) and c) is required in the same way
announce the commencement and termination of its activities regarding the preparation of medicinal products
, Institute. Within supervision, the Institute is entitled to prohibit the preparation of medicinal products by
technological prescriptions which do not ensure
quality, efficacy and safety of the medicines.

(5) The professional prerequisite for handling pharmaceuticals, if conducted in pharmacies
is to perform medical profession
pharmacist or pharmaceutical assistant pursuant to special legislation ^ 29).

(6) The provider of pharmacy health services must have for every
pharmacy appointed a compliance least one person with specialized qualifications of pharmacists
^ 31) (hereinafter referred to as "chief pharmacist") responsible for ensuring that the handling
drugs at the pharmacy this equation. Head
pharmacist can be a provider of pharmaceutical health services if
meets the qualification requirements under the first sentence. The pharmacy
for its operation must always be present chief pharmacist or a pharmacist authorized
. The same person may be appointed head of
pharmacist for only one pharmacy.

(7) The provider of health services pursuant to paragraph 2. b) c)
which prepares medicinal products must appoint at least one person
responsible for ensuring that the activities of healthcare providers
responsible for the preparation and handling of drugs this law that
technological processes preparation ensure quality, efficacy and safety
medicinal products prepared and that the preparation, dispensing and further handling
drugs involved only people with the necessary skills ^ 29).
Professional prerequisite for this responsible person's fitness for the medical profession as a pharmacist
^ 31) ^ 31 or physician) or
university degree in chemistry or biology and specialized
competence in the field of activity and 3 years professional experience in this field.

(8) For the preparation of medicinal products can only be used

) Medicinal substances and excipients listed in Czech Pharmacopoeia or
list established by the implementing legislation, or whose use
permit was issued by the Ministry of Health according to § 11 point. b)
or the Central Veterinary Administration pursuant to § 15 point. d);
way to demonstrate the quality of active ingredients and excipients shall be laid down
prescription

B) pathogens or antigens collected from individual patients, in the case of
preparation of human autogenous vaccines

C) registered medicinal products, if this method of use in
approved summary of the product or if it is determined
implementing legislation.

(9) Upcoming medicines or active substances and other substances
designed to prepare medicines pharmacy may also be tapped by
another pharmacy. In a decision issued pursuant to a special legal regulation
^ 71) pharmacy which prepares medicinal products or medicinal
substances and excipients checks, however, must be the extent of the preparation, monitoring and withdrawing
pharmacy explicitly mentioned.

(10) treatment medicines under § 5 para. 4
are in compliance with the conditions laid down by special legal regulations 72) and
§ 23 authorized the provision of health services only
medical personnel authorized provider health services.
Implementing legal regulation stipulates the scope of procedures considered
editing and defining the technical conditions of work for special groups of medicinal products
. The implementing legal regulation stipulates the method of handling
medicines Subscribed provider of health services,
preservation and documentation.

§ 79a

Individually prepared medicines containing cannabis for therapeutic use


(1) For therapeutic purposes, is individually prepared with
medicine containing cannabis for therapeutic use may prescribe, enact and apply
in accordance with the implementing regulation, which provides


A) the types of therapeutic cannabis and indications for which it can be used

B) individually prepared to prescription medicine with
content of cannabis for medical use amount in a specified period (
referred to as "quantitative restrictions")

C) specialized qualifications of physicians who can individually
prepared a medicine containing the therapeutic cannabis for individual diagnoses
prescribe.

(2) For the purposes of the preparation of individually prepared medicines
containing cannabis for therapeutic uses, the operator of the pharmacy
authorized to process personal data of the patient and the prescriber to the extent necessary to carry out
preparation or dispensing in accordance with paragraph 3.

(3) Before the preparation of medicinal product
electronic prescription to a medicine containing cannabis for therapeutic use
a pharmacist to request the necessary data in the registry for medicinal products
limitation under § 81a and following data
treated to determine whether the condition for making quantitative limit.
The preparation takes place, was the patient with a limited amount
medicinal product within the specified period has already been issued, or if the registry
for Medicinal Products Limited in accordance with § 81a contains a record that is carried
preparation, which will be achieved through quantitative restrictions.
If the conditions are met to prepare, pharmacist promptly submit reports electronically
in the register under § 81a;
report contains information pursuant to § 81a paragraph. 1 point. a) and b); technical way of providing data
under § 81a paragraph. 1 point. a) and b) the implementing legislation.
Part 3


Prescribing, dispensing medicines and removing drugs
Section 1

Prescription medicines


§ 80

(1) Medicines prescribed by doctors to their expertise
providing health services and veterinarians by issuing
prescription that may be, after consultation with the patient,
in paper or electronic form a recipe for medicine limited by
§ 39 paragraph. 4 point. c) a recipe, which prescribes the medicine
containing cannabis for medicinal use, is issued solely in electronic form
. If it is a prescription
in electronic form (hereinafter referred to as "electronic prescription"), the prescribing physician must send it
according to § 81 central repository of electronic prescriptions
which he promptly communicate identification mark, which it is sent
electronic prescription is provided; if it is a prescription for medicine with
restrictions pursuant to § 39 par. 4 point. c) a recipe, which prescribes
medicine containing cannabis for medical use, central repository of electronic prescriptions
communicate the identification sign only
if the conditions for the prescription. The identifier,
on the basis of the prescribed medicine at the pharmacy issued must
prescribing doctor to advise the patient. The implementing regulation lays down
method of prescribing data indicated on medical
regulations and rules for use of prescriptions.
Further implementing regulation lays down the procedure and conditions for communication
prescribing physicians and pharmacists dispensing prescribed medicines with
central repository of electronic prescriptions, a way of creating
identification signs that central repository of electronic prescriptions provide
prescribers method of sending electronic prescriptions
prescribing physicians and the method of recording electronic
recipes, including records of electronic prescriptions, which were
medicinal products has been issued.

(2) When prescribing human medicines, doctors are obliged
proceed so as to avoid inappropriate or wasteful
dealing with medicinal products with regard to the nature and duration of disease
intended treatment given medicine.

§ 81

Central repository of electronic prescriptions

(1) central repository of electronic prescriptions established the Institute as part of its organizational
to secure the fulfillment of these tasks:

A) collect and receive electronic prescriptions sent
prescribing physicians

B) tell the doctor immediately after receiving the electronic prescription

Identification mark, on the basis of the prescribed medicine
issued in pharmacy

C) make available free of charge electronic prescription on which
prescribed medicine to be delivered, the pharmacist issuing the relevant
pharmacy Medicines, immediately after receipt of the request,

D) free of charge to secure continued access to the database of electronic prescriptions
prescribers and pharmacists in pharmacies issuing
prescribed medicines; also free of charge to secure access to the database of electronic prescriptions
health insurance in order
implementation of control activities according to the law governing public
health insurance

E) ensuring safety and security in the database of stored electronic prescriptions
against damage, loss or misuse
under a special legal regulation 36)

F) to ensure the protection and transmission of data in the event of termination,

G) promptly designate electronic prescription made available pursuant to subparagraph c)
and issued pursuant to § 82

(2) central repository of electronic prescriptions is connected with a register
Medicines Limited pursuant to § 81a in order to ensure
compliance with the restrictions in the marketing authorization pursuant to § 39 paragraph
. 4 point. c) a restriction set by the implementing legislation for
individually prepared medicinal product containing
cannabis for medical use.

§ 81a

Register of Medicinal Products Limited

(1) A register of medicines with restrictions designed to ensure
restrictions on prescribing and dispensing medicinal product
amount specified in the marketing authorization pursuant to § 39 par. 4 point. c) or §
39 paragraph. 5 and limitations specified in the implementing legislation
individually prepared medicinal product containing
cannabis for medical use (hereinafter "Medicines Limited").
Department as registry administrator for Medicinal Products Limited

A) processes data on prescribed and dispensed medicines with
restrictions

B) processes personal data on health service providers who
these medicines prescribed, dispensing pharmacists and
patients to whom these medicines are prepared or issued in
range identification number of the insured, nejde- If insured by public health insurance
name, surname and date of birth of individuals
that the medicine was issued and the code of the medicinal product if it is assigned
Institute issued amount, date of issue recipe
date of dispensing and prescribing identify healthcare providers
indicating his number allocated to health insurance, if
health insurance allocated issuing pharmacist stating his
number assigned by the Czech chamber of Pharmacists and the operator of a licensed
dispensing,

C) ensures continuous access without charge to the prescriber
data under a) and b) relating to the patient, which is to be
prescribed medicine limitation, immediately after receiving the request prescriber
,

D) ensures continuous access without charge to the issuing pharmacist
to data under a) and b) relating to the patient, who has
be prepared or issued a medicinal product with a restriction, and that immediately after receiving
request the issuing pharmacist

E) processes and stores personal data about patients by prescribing
health service providers and dispensing pharmacists after picking
fruition only after a period for which the quantitative restrictions
medicine provided

First the marketing authorization pursuant to § 39 par. 4 point. c) or § 39 paragraph
. 5 of authorized medicinal products or

Second in the implementing regulation under § 79a paragraph.
1 for individually prepared medicinal products containing cannabis for medical use;
If it occurred to dispense, the period from the date of verification that
conditions are met to prepare.

(2) Medicines restriction is not publicly accessible.
Prescriber and pharmacist issuing a registry for medicinal products
limited access to personal data of the patient to

Verify that they are in relation to this subject, which is to be such
medicine prescribed, prepared and issued conditions
restrictions laid down in the decision of a medicinal product or
implementing legislation.
Section 2


Dispensing medicines and sale of selected pharmaceuticals

§ 82
General principles


(1) Medicines are issued on a valid prescription, which may
be in paper form or electronic prescription or medical
prescription issued in a Member State unless a decision on registration provided
otherwise. Medicines containing narcotic or psychotropic substances
which can be issued only on prescription with a blue stripe
under a special law, can not go to medical
prescription issued in another Member State. Method of prescribing, data
placed on the prescription and rules for use of prescriptions
in the implementing legislation. When dispensing on electronic prescription
issuing pharmacist must immediately notify the central repository of electronic prescriptions
that the prescribed medicinal product has already been issued.
Implementing legal regulation stipulates the method validation prescription, dispensing
keeping records, providing information on issued
medicinal products and the method of dispensing. Dispensing a valid prescription is also
dispensing medicine according to § 39 par. 4 prescribed by a doctor without
specialized competencies.

(2) medicines are authorized to issue in pharmacies and facilities
referred to in subparagraphs c) to g) persons referred to in subparagraphs a) to g).
It is about these people:

A) pharmacists in pharmacies,

B) pharma assistants ^ 33) in pharmacies and only medicines
whose output is not subject to medical prescription, except
medicinal products without a prescription restriction,

C) Employees of public health authorities with competence
to the medical profession of physician, allied health professionals and others
professionals with the competence to perform the medical profession
^ 73), and only immunological formulations for vaccination

D) doctors, pharmacists or other health professionals
transfusion service facilities commission for this activity and only blood derivatives;
Implementing legal regulation stipulates the scope and method of dispensing
blood derivatives

E) doctors, pharmacists or other health care facility staff
transfusion services and blood banks assigned to this task, and only
blood products; implementing legal regulation stipulates the method and extent
dispensing of blood products

F) doctors, pharmacists or other health care workers at the workplace
nuclear medicine healthcare providers who are entrusted
responsible person according to § 79 para. 7, and only radiopharmaceuticals
on this site prepared by § 79 par. 2 point. b) or

G) doctors, pharmacists or other health professionals to
immunology or microbiology workplace
providers of health services or equipment to protect public health, who are charged
responsible person according to § 79 para. 7, and only the
human autogenous vaccines on this site prepared according to § 79 para. 2 point. C).

Medicines are further authorized to issue veterinarians
authorized to perform professional veterinary activity pursuant to special legislation
^ 18), and medicines to treat animals.
This provision does not affect the use of medicines in providing
health services and veterinary care pursuant to § 5. 8th

(3) Operators authorized to dispense under paragraph 2

A) ensure not to jeopardize the quality of medicines and that
handling of medicinal products complies with the conditions laid down in
decision on their registration

B) withdraw medicines subject to registration under § 25
only from the manufacturer, in the case of medicines produced by him, from a distributor
or from a pharmacy in accordance with paragraph 4

C) shall not, except as a preparation or dispensing of medicines
for healthcare providers, disrupt the integrity of the packaging
medicinal product subject to registration pursuant to § 25


D) they are obliged to ensure the dispensing of medicinal products referred to in paragraph 75
. 1 point. a) and b) dispensing records using their codes and this
records kept for 5 years; they are also obliged to provide information on the Institute
dispensed medicinal products; the scope of data and the method of providing
form of reports published by the Institute in its information
resource

E) keep a complete and conclusive records inventory receipt and issue
medicinal products referred to in § 75 para. 1 point. a) and b) after
individual items which enable dosage form, quantity
active substance contained in a unit weight, volume or dosage forms
type of packaging and pack size of a medicinal product, including the code
medicinal product, and keep these records for 5 years

F) if the operator of the pharmacy, performed in process
holder of the marketing authorization pursuant to § 33 par. 3 point. c) all necessary measures
to pharmacy may be exchanged
medicinal product for which a defect was detected in quality;
implementing legal regulation stipulates the content requirements and method of keeping records related to the exchange
downloaded medicines

G) if the operator of the pharmacy, who is also the holder of the license to distribute
is available for orders of a medicinal product shall be obliged to inform the distributor
whether the medicine is taken as an operator
pharmacy or distributor.

(4) If a pharmacy dispensing pharmacies or other
providers of inpatient care, should be subscribing
pharmacy or provider of inpatient care in the decision issued
issuing a pharmacy in accordance with the law on health services. Unless the medicinal
products that are prepared at the pharmacy, the pharmacy is exceptionally
Remove from another pharmacy, where no such medicine to
available and can not obtain the required time from the distributor or
when another pharmacy untapped medicinal product that is not
returned to the distributor. Such a provision removing
medicinal products to pharmacies is not for distribution and pharmacy about it
keep the records in the extent and manner specified by the implementing legal regulation
. Pharmacy, whose operator is also the holder of a
distribution should not be used to distribute medicines procured
as a chemist.

(5) Medicinal products prepared at a nuclear medicine workplace
healthcare providers and human autogenous vaccine prepared
on immunology or microbiology workplace
provider of health services shall be issued only to providers of health services
.

(6) Selected medicinal products are authorized to sell only eligible
vendors of selected medicinal products
business according to special legal regulation 74). Selected medicinal products may take
exclusively from the manufacturer, if it made a dedicated medicines
or from a distributor and can store them for purposes of sale under the conditions specified by the manufacturer
medicines.

(7) Operators dispensing medicinal products pursuant to paragraph 2
are obliged to provide information on proper use and storage of medicinal products
; the persons referred to in paragraph 6 shall fulfill this obligation by selling
medicinal product containing a leaflet.

§ 83

Dispensing medicines in pharmacies

(1) The operator authorized to dispense medicines issue
doctor prescribed medicine or solicited medicine dispensing
which is not subject to medical prescription; when the medicines were dispensed in pharmacies
they are obliged to act in accordance with the established classification of a medicinal product for dispensing
according to § 39. If a medicinal product is included in the category
dispensing without a prescription and dispensing of such patient || | requires operator of a pharmacy may not make the issue of medicinal
submitting to the patient a prescription without prior
evaluating whether, in this case those limits are respected.

(2) Indicate if the prescribing doctor on the prescription, insisting on
issue of prescribed medicine, an operator
entitled to supply medicinal products pursuant to § 82 para. 2 issue only prescribed

Medicine. In other cases, inform the patient about the possible alternatives
emitted from the medicinal product with its consent
is entitled to replace a prescribed medicine with another medicine
which is identical in terms of its efficacy and safety, it contains the same
the active ingredient is the same route of administration and the same pharmaceutical form
. Confusion medicinal product for the purposes of its reimbursement may provide
law regulating public health insurance.
Implementing legal regulation stipulates the method of dispensing and indicating the possibility of confusion of medicinal product
prescriptions.

(3) Unless the pharmacist medicine prescribed by the doctor
available and if it is necessary for his immediate release, issued another medicine
corresponding therapeutic properties that is available.
Implementing legal regulation stipulates the cases where it is necessary to immediately release
medicinal product and the extent of the replacement of the prescribed medicinal product.

(4) In case of doubts about the credibility of a prescription must be issued
medicine, and is unable to resolve such doubts, even after
verification with the prescribing physician must be the case without undue delay announced
police of the Czech Republic. Medicine, whose output
subject to medical prescription may be issued and a person other than that
medicine prescribed. If, however, the pharmacist doubt that
person who gives the medicine is not able to guarantee the correct
use of the product or it can exploit, medicine
issued. Medicine, whose output is not subject to medical prescription issued
pharmacist or pharmaceutical assistant also in case of suspicion of abuse
this medicine.

(5) For the purposes of issuing medicines on prescription with
restrictions pursuant to § 39 par. 4 or medicines without medical prescription
limited according to § 39 par. 5 of the operator is authorized to dispense
may process personal data of the patient to the extent necessary to carry out
output in accordance with the authorization given
medicine. Issuing pharmacist with respect to the nature
restrictions require the necessary information in the registry for medicines with
restrictions under § 81a and processes these data in order to determine whether the conditions
output. Pharmacist dispensing fails, if the patient
limited amount of medicinal product within the specified period has already issued
or were not met other conditions of dispensing. In case of a
picking conditions requiring verification of output in the registry for medicinal products
Limited pursuant to § 81a shall promptly issuing a pharmacist
electronic messages to this register; The report contains data according to §
81a paragraph. 1 point. b); technical way of providing the data
in the implementing legislation.

(6) The pharmacy is also obliged

A) when dispensing inform the patient about the actual amount of reimbursement from public health insurance
issued collectively pack on each item
prescription

B) proceed when dispensing medicines and keeping records
output in accordance with the rules of good laboratory practice laid down
implementing legislation.

(7) An implementing regulation provides record-keeping method of dispensing,
content requirements documentation of dispensing and dispensing procedure.

(8) When dispensing individually prepared medicines containing
cannabis for medicinal use, the operator is authorized to dispense
authorized to process personal data of the patient and the prescribing provider
health services in order to confirm that the individual | || upcoming medicine was issued.

§ 84

General principles of mail-order dispensing

(1) mail-order dispensing of medicinal products (hereinafter referred to as "mail-order dispensing")
means dispensing medicines based mail-order
way. Offering medicinal products for their
mail-order dispensing and receiving orders persons (hereinafter referred to as "Customer")
realization of mail-order dispensing shall be considered part of mail-order dispensing
.

(2) Mail-order dispensing, and even abroad, may provide only
operator of the pharmacy ^ 9) (hereinafter "pharmacy providing mail-order dispensing
").


(3) A pharmacy providing mail-order dispensing is required to notify the Department
commencement, suspension and termination of mail-order dispensing within 15 days
date on which the event occurred. Part of the notice of initiation
mail-order dispensing with the address of the website where
pharmacy will be offered Medicinal Products for dispensing to the public
remotely by electronic means; in such a case
pharmacy is required to notify the Department of a change such addresses, not later than
15 days from the date when such a change occurred.
Implementing legal regulation stipulates the scope of data and the method of notification.

(4) The Institute publishes on the Internet

A) information on the legislation of the Czech Republic, which regulate
offering medicinal products for supply to the public at a distance
by mail order dispensing with the use of electronic
resources, including information on the fact that the Member States || | there may be differences in the classification of medicines and the conditions for their
dispensing,

B) information about the purpose of the logo referred to in § 85 para. 3 point. b)

C) a list of persons offering Medicinal Products for sale
public by means of mail-order dispensing with the use of electronic means and
submitted notifications in accordance with paragraph 3,
and addresses of their websites | ||
D) general information about the risks of medicines
supplied illegally to the public via mail order dispensing with electronic means
and

E) a hyperlink to the website established by the Agency.

§ 85

Obligations pharmacy providing mail-order dispensing

(1) The subject of the mail-order dispensing may be only medicines
registered according to § 25 paragraph. 1, whose dispensing according
decision on registration is limited according to § 39 par. 5 or not subject to medical
regulation. The implementing regulation lays down the method of ensuring
mail-order dispensing.

(2) A pharmacy providing mail-order dispensing is required to ensure

A) disclosures about mail-order dispensing,
offer medicinal products, their prices and costs associated with the mail-order dispensing;
Mere publication of the offer is not considered advertising under special
legal regulation 51)

B) the packaging and transport of consignments containing medicinal products for delivery
customer in a manner that will maintain the quality of medicinal products
; pharmacy providing mail-order dispensing
responsible for the quality of medicines, even if that provide contracted transportation
medicines with others,

C) that the consignments were sent to the customer at the latest within 48 hours from receipt of the order
so as to ensure their delivery to the customer
latest within three days from receipt of the order, or order ordering longest
within 3 days of receipt of the order announced that during this period
consignment can not be delivered,

D) information service provided by a pharmacist or a pharmaceutical assistant
for a limited hours of operation; This information service is used
well as to ensure the collection and transmission of information on suspected
adverse reactions and quality defects of medicinal products which had been
notified

E) the possibility of returning the claimed medicinal products in a manner that does not cause
customer costs; Medicines such
become unusable pharmaceuticals and the need to ensure their removal under § 88 and 89.


(3) In addition to the information set out in special legislation ^ 93) must
websites pharmacy providing mail-order dispensing contain mainly


) Contact details Institute and a hyperlink to the website of the Institute and


B) on each page of the website that relates to the offer
supplying medicinal products to the public at a distance clearly displayed logo
containing requirements provided directly applicable regulation
European Union, allowing the identification of the Member State in which
the person offering medicinal products established; that logo
hyperlink to the entry of the person in the list referred to in § 84 para. 4
point. C).

§ 86

Mail-order dispensing abroad

(1) Medicinal products intended for delivery abroad may be labeled in
official language of the state in which they are delivered. implementing legislation

Regulation stipulates the method of handling medicinal products labeled as follows
foreign languages, including details of their removal and storage. Furthermore
implementing legal regulation stipulates the method for relabeling
medicinal products. Relabeling may provide only manufacturer of medicinal products
.

(2) Mail-order dispensing abroad shall be subject to the provisions of § 84 and 85 with the exception
deadlines for shipping and delivery according to § 85 para. 2 point. C).

§ 87

Mail-order dispensing into the Czech Republic

(1) Persons residing in the Czech Republic may
for his personal use and the use of order or otherwise obtain from abroad
human medicinal products only via mail-order dispensing
effected from another Member State. The subject of mail-order dispensing may be only medicines


A) registered pursuant to § 25 par. 1

B) registered in the Member State from which the mail-order dispensing
implemented,

C) the issue by the Holder is not in the Czech Republic
limited according to § 39 par. 5 or not subject to medical prescription or
restricted medical prescription and

D) supplied in accordance with the terms of the marketing authorization issued in the Czech Republic
or the conditions of registration under the directly applicable regulations of the European Union
^ 24); on request individual patient in an amount corresponding to his personal needs
possible delivery of the medicinal product designation for
and package leaflet in a language other than Czech.

(2) For the packaging of medicinal products referred to in paragraph 1 shall
provisions of § 85 para. 2 point. b).
Section 3



Drug Trouble
§ 88

(1) Pharmaceuticals unsatisfactory quality, with expired shelf life,
stored or prepared under other than prescribed conditions, obviously damaged or unused
(hereinafter "unusable medicines") must be removed, including their
packages so as to avoid danger to life and
human or animal health or the environment.

(2) The management of unusable drugs proceeds like when
hazardous waste management, including the management of their records according
special legal regulation 56). Unusable transfusion products and
advanced therapy products are disposed of as waste whose collection and removal
subject to special requirements in order to prevent infection
^ 75).

(3) Disposal of unusable pharmaceuticals conducted
legal or natural persons on the basis of consent granted by the regional authority delegated competence
^ 56) or, in the case of radiopharmaceuticals, by the State Office for Nuclear Safety
. The informed consent authority which granted the approval
, Ministry of Health, in the case of human medicines or the
Ministry of Agriculture, in the case of veterinary medicine, while
communicated information includes the name of the technical facilities serving for
disposal of unusable drugs, which is the legal or natural person
operator.

(4) The persons referred to in paragraph 3 are obliged to keep records
deleted unused medicines in accordance with special legal regulations
^ 75).

(5) The provisions of paragraphs 1 through 4 shall apply mutatis mutandis to handle such
products that were not marketed as medicines, but it was about them
according to § 13 para. 2 point. h) or pursuant to § 16 para. 2 point. f)
decided that the medicines.

§ 89

(1) Operators are obliged to surrender unusable medicines
persons referred to in § 88 para. 3rd

(2) unusable medicines surrendered by individuals pharmacy pharmacy
obliged to accept. Costs incurred by the pharmacy with the surrender of unusable medicines
persons referred to in § 88 par. 3 and deleting these
persons paid by the state through the regional office.

(3) if a withdrawal of a medicinal product from the market
holder of the authorization does not apply to operators paragraph 1. Operators
act of presentation of unused medicines by
instructions MAH, who is obliged to pay them
proven costs incurred in such submission, or cost
incurred in connection with the acquisition and storage of the transferred
medicinal product, if no such issuance. Health insurance companies and patients have

Against the marketing authorization holder is entitled to reimbursement of costs incurred on
packaging of medicinal products which have been withdrawn without compensation
from circulation.
TITLE V

PHARMACOVIGILANCE


Ensuring pharmacovigilance of medicinal products for human use

§ 90

Pharmacovigilance system in the Czech Republic

(1) The Institute for the fulfillment of its pharmacovigilance tasks and
cooperation in this field within the European Union operates
pharmacovigilance system in the Czech Republic, through which

A) collects information on the risks of medicinal products for
patients' health or public health, including information on adverse
effects associated with the use of medicines in accordance with or in contravention
registration and adverse events associated with
treatment with drugs in the workplace,

B) evaluates the information referred to in subparagraph a) and is considering the possibility of reducing
risk associated with the use of medicinal products for human and
prevention

C) take measures consisting in change, suspension or revocation
registration, prohibiting supply or use of medicinal products or their
withdrawal from the market.

(2) The Institute is supporting pharmacovigilance measures that

A) motivates doctors, pharmacists, other health professionals and patients
to the Institute report suspected adverse reactions

B) allows you to report those suspicions different ways, not only through the Internet
,

C) publishes information on pharmacovigilance concerns that
concerning the use of medicinal products in the information media of the Institute
enabling remote access, as appropriate, other ways of informing the public
.

(3) The decision of the Institute ex officio prohibit the dispensing or use of medicinal product
download or order the medicine if

A) the medicinal product is harmful

B) a medicinal product lacks therapeutic efficacy,

C) risks outweigh its merits,

D) qualitative and quantitative composition is not
composition of the registration

E) are not the manufacturer or marketing authorization holder performed
controls on the medicinal product or its ingredients and the controls at an intermediate stage of the manufacturing process
or

F) the marketing authorization holder violated the obligation arising from
permit to manufacture medicinal products.

(4) The Institute may limit the prohibition to supply or use of the product, or its withdrawal
to specific batches.

(5) An appeal against the decision to ban the supply or use of the medicinal product or
decision ordering the withdrawal of a medicinal product has
suspensive effect.

(6) The decision to ban the supply or use of the product or
withdrawal of a medicinal product pursuant to paragraph 3, the Institute may, in exceptional cases
and the time necessary to enable the supply or use of such
medicine for patients who are already on this medicinal product
treated.

(7) The Institute carries out a regular audit of the pharmacovigilance system
Czech Republic and communicate the results to the Commission every two years starting September 21
2013. The Institute of Pharmacovigilance follow the instructions of the Commission and the Agency
^ 94).

§ 91

Pharmacovigilance system MAH

(1) The marketing authorization holder must, in order to fulfill its tasks in the field of pharmacovigilance
operate a pharmacovigilance system
corresponding pharmacovigilance system in the Czech Republic, through which


A) collects information on the risks of medicinal products for which the
MAH,

B) evaluates the information referred to in subparagraph a), and is considering options to reduce
risk and its prevention

C) if necessary, appropriate arrangements.

(2) The marketing authorization holder is obliged

A) lead and at the request of the Department within 7 days to make available a copy of the basic
pharmacovigilance system,

B) promptly inform the Department about changing the basic document
pharmacovigilance system, if located in the territory of the Czech Republic,

C) for each medicinal product, run and upgrade
risk management system, which must be proportionate to the identified and potential risks of such

Medicine and the need for obtaining post-marketing data
security

D) monitor the impact of measures to reduce risks, which includes a plan
risk management or which are laid down as a condition of registration and
specific obligations in accordance with § 31a, § 32 par. 3 and § 32a

E) monitor pharmacovigilance data to determine whether they appeared
new risks have changed risks identified and there was no change in
risk-benefit ratio of medicinal products

F) keep documents relating to pharmacovigilance
at least 10 years from the acquisition of documentation;
implementing regulation provides content requirements, the conduct and the retention period
documentation relating to pharmacovigilance.

(3) The marketing authorization holder shall perform a regular audit of their pharmacovigilance
system. If the results of the audit
suggest that there should be corrective measures, holder
Holder these results together with a plan of corrective measures
recorded in the pharmacovigilance system
and corrective actions performed. Once the corrective measures
authorized to remove this record.

(4) Holders of marketing authorizations in the field of pharmacovigilance governed
Commission guidelines, the agency ^ 94) and the Institute.

§ 91a

Qualified person responsible for pharmacovigilance

(1) The marketing authorization holder shall have permanently and continuously available
qualified person responsible for pharmacovigilance.

(2) The qualified person responsible for pharmacovigilance
responsible for the creation and maintenance of the pharmacovigilance system and must be resident and
perform its tasks in the area of ​​pharmacovigilance in the European Union.
MAH shall notify the name and contact information
qualified person responsible for pharmacovigilance Institute and the Agency.

(3) The Institute may request the marketing authorization holder
appointing a contact person for pharmacovigilance issues in the Czech Republic, which
reporting to the qualified person responsible for pharmacovigilance.

(4) The marketing authorization holder shall immediately inform
Department in case of change of the qualified person responsible for pharmacovigilance
or change their contact details; similarly informed about changes
concerning the contact person.

§ 92

(1) If there are doubts about the risks that affect
risk-benefit balance of an authorized medicinal product may
Institute of the proceedings ex officio the change of registration holder of the registration
impose the obligation to operate a risk management system in accordance with § 91 paragraph
. 2 point. c) in the event that such a system has not completed or
edit it if it already operates and to oblige
submit a detailed description of the risk management system. Such a change represents registration
terms of registration under § 31a point. and).

(2) The notice of arbitration shall in addition to the general requirements
include targets and a timetable for implementation of the obligations imposed
and must be duly justified. Department of the notice of initiation states
marketing authorization holder days to comment at least 30 days
. If the Department finds that the procedure referred to in paragraph 1 is in this case
necessary, control the change of registration stops.

(3) If the Department finds no grounds for stopping proceedings, issue a decision, which changed
registration of the medicinal product.
Holder Holder introduce a risk management system or it
adjusted accordingly.

§ 93

Public announcement on pharmacovigilance concerns

(1) If the Institute intends to make a public announcement, inform the competent
authorities of other Member States, the Agency and the Commission within 24 hours
before a public announcement is to be made. This does not apply if the Institute
concludes that protect public health, it is necessary to make
urgent public announcements.

(2) A notification concerning the safety of medicinal products containing
active substances contained in medicinal products authorized
in several Member States, coordinated by the Agency in cooperation with the Institute
and the competent authorities of other Member States. In the event that the
action is taken in the form of such a notice Security Department
publish it after removing personal data and confidential business information

Nature, unless they are necessary to protect public health by
schedule determined by the agency.

(3) The marketing authorization holder may make a public announcement about
pharmacovigilance concerns relating to the use of his
medicine. About this plan must before or at the latest with
this notice to inform the Department of the Agency and the Commission.
Is also obliged to ensure that information not misleading to the public and were
presented objectively.

Recording and reporting of suspected adverse reactions

§ 93a

(1) The marketing authorization holder shall record and
one place in the European Union make available any reports of suspected adverse reactions
its authorized medicines that
occur in the European Union and and in third countries, which are not
regardless of their form and mode of transmission learns

A) from patients

B) from health professionals,

C) of the medical literature, which is obliged to observe

D) in the context of post-marketing studies, except for the messages that occur in
clinical trials.

(2) The marketing authorization holder is required to submit electronically to the database and
data-processing network referred to in directly applicable
EU regulations governing the procedure for the authorization and supervision of medicinal products
^ 95) (hereinafter the "Eudravigilance database")
information about all suspected adverse reactions, in the case

A) serious suspected adverse reactions that occur in the
European Union and in third countries, within 15 days from the date when the
such suspicions learned

B) non- serious suspected adverse reactions that occur in
European Union, within 90 days of the date on which such suspicions are learned.

(3) The MAH not required to report to the Eudravigilance database
suspected adverse reactions recorded in the medical literature
in the event that the medicinal product contains an active substance listed in
list of medicinal substances monitored by the Agency
directly applicable EU regulations governing the procedure for
authorization and supervision of medicinal products ^ 96) and medical literature,
from which this suspicion is clear is listed in the bibliography
monitored by the Agency under this directly applicable
regulations of the European Union.

(4) The marketing authorization holder is obliged to take adequate measures
in order to obtain accurate and verifiable data for the required
evaluation reports of suspected adverse reaction
collect additional relevant information in relation to these reports and
send updates to the Eudravigilance database. MAH
is obliged to cooperate with the Agency and the Institute for identifying duplicate
reports of suspected adverse reaction.

(5) Prior to the commissioning of Eudravigilance is the holder of the marketing authorization
required to report suspected adverse reactions) of the Constitution in case
suspected serious adverse reactions that have been reported in
Czech Republic, to 15 days from the date when the event learned b)
agency for suspected serious adverse reactions that have been reported
in a third country within 15 days from the date when the events
learned; if the medicinal product is authorized in the Czech Republic
give this message also to the Department's request.

(6) The marketing authorization holder shall provide upon request
Institute synergy subsequent submission of information related to
sent by the reports referred to in paragraphs 2 and 5.

(7) Prior to the commissioning of Eudravigilance Institute is obliged
suspected serious adverse reactions in accordance with paragraph 5. a)
sent to the Agency within 15 days after their announcement.

§ 93b

(1) A doctor, dentist, pharmacist or other health professional, who scored
suspected serious or unexpected adverse reaction
or other factors associated with the use of a medicinal product that
are important for the health of patients is obliged

A) immediately notify the Department, even if
medicinal product has not been used in accordance with the summary of product characteristics or the
abused and

B) provide assistance in verifying the facts related

Suspected side effect and make available on request the Department
relevant documentation, including documentation containing personal data.

(2) In case of suspected adverse drug reaction reported
patient is required to provide the Department of synergy administration
subsequent information relating sent with the message.

§ 93c

(1) The Institute shall ensure that healthcare professionals and patients are able to
reports of suspected adverse reactions to use electronic forms
published on the website of the Institute, as well as other appropriate
funds and record all suspected adverse reactions
occurring in the territory of the Czech Republic.

(2) The Institute cooperates with the Agency and the marketing authorization holder
in the detection of duplicate reporting of suspected adverse effect.

(3) Department sends reports of suspected adverse reactions referred to in paragraph 1
electronically to the Eudravigilance

A) in the case of suspected serious adverse reactions within 15 days of their receipt
,

B) in the case of non-serious suspected adverse reactions within 90 days of their receipt
.

(4) The Institute is obliged to send in the periods referred to in paragraph 3
reports of suspected adverse reactions resulting from errors when using
medicine to Eudravigilance; This message must be
forms set out in directly applicable EU regulations
governing the procedure for the authorization and supervision of medicinal products ^ 97).

(5) The Institute shall take measures in order to uniquely identify each
biological medicinal product. It is all about the name and batch number
biological medicinal product or a prescription dispensed at
Czech Republic, which is subject to the reporting of suspected adverse reaction
through collection and analysis of information
including the possibility of subsequent interviews with the who report suspected adverse reaction
handed.

Regularly updated safety reports

§ 93d

(1) The marketing authorization holder shall be sent electronically to the Agency
regularly updated safety reports, which are part


A) information relevant to assessing the benefits and risks of medicinal
product, including the results of studies that may affect
authorization for this medicine,

B) a scientific evaluation of the risk-benefit balance of the medicinal product
; This evaluation shall be based on available data, including
data from clinical trials using valid notwithstanding the registration

C) all data relating to the volume of output and sales of the medicinal
product and any data on the extent of the prescription, the holder of the marketing authorization
available, including an estimate of the number of people who
this medicine used.

(2) The Institute has regularly updated reports on safety addressed in accordance with paragraph 1
access through the repository referred to in
directly applicable EU regulations governing the procedure for registration and
supervision of medicinal products ^ 98).

(3) The holder of a marketing authorization for medicinal products referred to in § 27 paragraph
. 1 or 7, homeopathic remedies under § 28a
traditional herbal medicinal products shall be sent electronically to the Agency
regularly updated safety reports for its medicinal
these products only, provided that

A) the obligation was set as a condition of registration or special
obligation under § 31a or § 32 par. 3, or

B) the sending requested by the Institute on the basis of pharmacovigilance
doubt or in cases when the medicinal product is not enough
regularly updated reports on safety
active ingredient, which contains a medicinal product.

(4) The Department shall submit an evaluation report regarding the requested
regularly updated reports on safety Pharmacovigilance Committee
risk assessment of pharmaceuticals.

(5) The Institute continually evaluates regularly updated reports on safety and
if it concludes that there are new risks,
changed the existing risks or changes to the risk-benefit balance of the medicinal product
may take the necessary measures consisting of

Amendment, suspension or revocation of registration.

(6) MAH first message sent to the Agency in accordance with paragraph 1
12 months after the date on which the agency announced
database functionality regularly updated reports on safety.
Period referred to in the first sentence sends MAH
report referred to in paragraphs 1 and 3 of the Constitution and the competent authorities of all Member States
in which the medicinal product was authorized.

§ 93E

(1) If the marketing authorization holder the obligation to submit
regularly updated reports on safety, the Institute provides
frequency of submission of such reports in the marketing authorization, including the date or
deadline for the first report on safety .

(2) If the Holder is not a fixed rate and date
submission of periodic safety update reports, the holder
marketing authorization of a medicinal product shall be obliged to submit
Institute regularly updated reports on safety || |
A) immediately, whenever requested by the Institute

B) where a medicinal product not yet been placed on the market, at least every 6
months after authorization until the product is placed on the
market

C) where a medicinal product already on the market, at least every 6 months
during the first 2 years following the initial placing on the market, further
once a year during the next 2 years and then every three years.

(3) medicines, which are subject to various registration and that
contain the same active substance or the same combination of drugs, may be
date or frequency of submission of periodic updated safety reports
harmonized so that is it possible to assess
uniformly according to § 93f. For this purpose, the Committee for Medicinal Products or
Coordinating Group determines concerned
active substances or combinations of active substances reference date
European Union and the frequency of submission of periodic safety update reports.
In this case, the marketing authorization holder of the medicinal product
obliged to submit an application for change of registration
consisting in changing the date or the frequency of submission of periodic
safety update reports by the agency set
harmonization.

(4) If, based on the setting or change the reference data
European Union must change the dates or the frequency of submission of periodic
safety update reports for decision to change the registration
this decision can not take effect earlier than 6
months from the date of the determination or change the reference data of the European Union.

§ 93f

(1) If the Institute is in charge of coordinating group or
Pharmacovigilance Risk Assessment Committee, pharmaceuticals, drawn up in the single
assessment evaluation report regularly updated reports
safety of the medicines under § 93E paragraph. 3 which are
registered in several Member States. This evaluation report drawn up by
within 60 days of receipt of the periodic safety update reports and
send it to the Agency and Member States concerned. The holder of a registration
receive the evaluation report from the agency. Other Member States and
marketing authorization holder may, within 30 days to receive comments
evaluation report. The Institute shall within 15 days update the assessment report with respect
relied on the comments and pass it
Pharmacovigilance Risk Assessment Committee medicines.

(2) In the event that the evaluation report prepared by the Single
assessment, the competent authority of another Member State, the Institute
this institution and the Agency within 30 days of its receipt may submit comments
.

§ 93 g

(1) On the basis of its own assessment of regularly updated reports
Security Institute may change, suspend or cancel the registration
medicine.

(2) Based on the agreements resulting from the assessment of the results of a single
regularly reviews safety update reports received
coordination group shall

A) Department to suspend or cancel the registration, or

B) the marketing authorization holder to submit an application for change of registration
including an updated summary of product characteristics and the package leaflet.

Urgent procedure laid down by the European Union

§ 93H

(1) Institute in cooperation with the Agency


A) monitor the results of actions to reduce the risks, which include plans
risk management and the conditions and obligations set forth in § 31a, § 32 paragraph
. 3 or § 32a

B) assess updates to the risk management system

C) monitor the data in the Eudravigilance database to determine whether
there are new risks or risks have changed and whether
impact on the risk-benefit ratio.

(2) Marketing Authorisation Holder and the Department are obliged to inform each other
if it finds new risks or changes to previously identified risks
or changes in the risk-benefit ratio;
also are required to inform the Agency and the competent authorities of other Member States.

§ 93i

(1) If the Institute within its pharmacovigilance activities
finds serious matters relating to human medicine, begins
urgent procedure established by the European Union in that
inform the competent authorities of other Member States Agency and
Commission. Department procedure begins when considering

A) suspending or revoking a registration

B) prohibition on supply or use of the product, or

C) refusal to renew a registration.

(2) The Institute shall proceed in accordance with paragraph 1 Similarly, if you
holder of the marketing authorization informed that on the basis of doubts about the safety
interrupted the medicinal product on the market or that it intends
request the cancellation of the registration or deregistration
been asked or not asked for its extension.

(3) As part of the information forwarded to the Agency under paragraph 1 or 2
provide all relevant scientific information that the Department for
available and the results of the assessment it has made.

(4) In the event that, with regard to the protection of public health requires
circumstances shall immediately take the necessary measures, the Institute itself or at the request of the Commission
decide to temporarily suspend the registration or prohibiting
issue or medicinal use preparation.
Appeal against this decision has no suspensive effect. That decision and its reasons
Department is obliged by the next working day
inform the Commission and the competent authorities of other Member States.

(5) If the coordination group in their agreement resulting from the procedure for urgent matters
set by the European Union to recommend a change
suspension or revocation of registration, the Institute or
holder of the marketing authorization pursuant to § 93 g paragraph. 2 accordingly.

(6) The Institute shall inform the competent authorities of other Member States
Agency and the Commission when considering the addition of a new contraindication, a reduction
recommended dose, or a restriction to the indications. The information referred to in the first sentence
Department indicate measures under consideration and their reasons. In this case
or if the Department receives such information from the competent authorities
other Member States or the Commission may also initiate the procedure provided for in paragraph 1


(7) If, in the case of medicinal products authorized under §
41 and 42, the procedure for urgent matters, before the Constitution thing
coordination group.

Non-interventional post-authorization safety studies

§ 93j

(1) MAH, which designs, manages or finances
non-interventional post-authorization safety study under
own decision or on the basis of the conditions and obligations imposed on him by
§ § 31a or 32a, and which includes the collection of safety data from patients or
medical staff is obliged to inform in advance
Department to initiate a non-interventional post-marketing studies
security underway in the Czech Republic and its completion.
Implementing legal regulation stipulates the scope and method of providing information to the Institute.
Department may require the submission of a progress report containing information about
course of the study. The MAH shall submit within 12 months
since the data of the Institute of the final report.

(2) The MAH shall provide healthcare professionals
for participating in the studies referred to in paragraph 1
financial compensation beyond reimbursement of their time and expenses incurred.

(3) During the study, the MAH
obliged to monitor and assess the data collected and their impact on the
risk-benefit balance of the medicinal product. All new information

May affect the assessment of risk-benefit ratio is obliged
MAH communicate according to § 33 of the Constitution;
this does not affect its obligation to disclose the results of the study through
regular safety update reports in accordance with § 93d.

(4) Non-interventional post-authorization safety studies must be carried
if they promote the use of the medicinal product
.

(5) If based on the results of the study need to change the registration is
MAH must lodge an application for an amendment.

(6) If the coordination group in their agreement arising from the results of the study
notify the need to make a change, suspension or revocation of registration
, the Institute or MAH according
§ 93 g paragraph. 2 accordingly.

§ 93k

(1) If the MAH will conduct
non-interventional post-authorization safety study on the conditions and obligations imposed on him by
§ § 31a or 32a only in the Czech Republic
submit to the Department at least 60 days before the commencement of the draft protocol. If
trial will be conducted in several Member States, the holder
registrant must submit a draft protocol instead Institute
Pharmacovigilance Risk Assessment Committee medicines.

(2) Department within 60 days of submission of the draft protocol

A) issue consent to the draft protocol,

B) notify the marketing authorization holder reasoned disagreement, if
considers that the study design does not meet its objectives or aims mainly to promote
medicine or

C) notify the marketing authorization holder that the study is a clinical
evaluation.

(3) The study referred to in paragraph 1 may commence only with the written consent
Institute or the Pharmacovigilance Risk Assessment Committee
drugs. If consent is granted Pharmacovigilance Assessment Committee
risk of drugs and studies to be carried out in the Czech Republic, the holder
Holder must send a Constitution approved protocol
prior to study initiation.

(4) Any substantial change protocol after the start of the study can be done
only with the prior consent of the authority that approved the protocol. If that authority
Pharmacovigilance Risk Assessment Committee medicines
MAH if the study is conducted on the territory of the Czech Republic
shall notify this amendment to Protocol Department.

(5) Upon completion of the study, the MAH is obliged
electronically sent to the competent authority, a summary of its results.

Ensuring pharmacovigilance of veterinary medicines

§ 94

(1) Veterinarian shall report the marketing authorization holder
medicine or Veterinary Institute
incidence of serious adverse drug reaction, unexpected adverse reaction
medicine or undesirable effect which is related to | || this medicine occurred in humans, even when this
medicine has not been used in accordance with the summary of product
been used incorrectly or was abused. In the event of a serious breach of this obligation may
Veterinary Institute
competent veterinary doctor decide on the suspension of prescribing, dispensing and use of medicines
in veterinary care. Such a measure
Veterinary Institute shall inform the operator. Decisions forward Veterinary Institute
Chamber of Veterinary Surgeons ^ 76), which falls in line with internal regulations
discussed. Informed of the outcome
Chamber of Veterinary Surgeons Veterinary Institute.
Veterinary Institute shall revoke the decision on suspension of prescribing, dispensing and use of medicinal
products in veterinary care immediately after the receipt
from the Chamber of Veterinary Surgeons result of dealing with the matter.

(2) to take decisions that are in line with measures
accepted in the European Union, the Veterinary Institute
pharmacovigilance system to collect information relevant for monitoring the properties
medicines and their side effects
in connection with medicinal products appear in animals and people, and their expert evaluation
.

(3) The assessment carried out under paragraph 2 of the Veterinary Institute with regard to

Data on the amount of medicinal product placed on the market.

(4) The Veterinary Institute shall ensure that the information referred to in paragraph 2 are
transmitted to other Member States and the Agency, and that they are consistent with the Commission's guidelines and
agencies are recorded in a database provided by
directly applicable European EU-24).

(5) pharmacovigilance system referred to in paragraph 2 shall also take into account
information about other aspects of adverse drug reactions,
which may affect their evaluation with regard to the benefits and risks, particularly information
by

A) lack of efficacy of medicinal products

B) use of medicines outside the scope of registration

C) adequacy of withdrawal periods of medicinal products

D) the potential risks of medicines for life
environment.

(6) The information referred to in paragraphs 2 and 5 evaluated by the Veterinary Institute
rules and requirements, which shall, in accordance with the rules and requirements
force in the European Union, and which shall be published in the information media
Veterinary Institute.

§ 95

(1) The marketing authorization holder shall have permanently and continuously
secured services of a person with an education in an accredited master's degree program
veterinary medicine ^ 19) or
accredited master's study program in veterinary hygiene and ecology or
in an accredited master's degree program pharmacy ^ 31), or
person with other appropriate qualifications. MAH
this person must furnish necessary authorizations and resources and
provide it without delay any information relating to the safety
medicines.

(2) The person responsible for pharmacovigilance referred to in paragraph 1 shall be
resident or established ^ 21) in the European Union is obliged to ensure

A) establishing and maintaining a system which ensures that information about all
suspected adverse reactions reported to employees
holder of a marketing and sales representatives are collected and evaluated
so as to be available for at least one point in the European Union
,

B) preparing the reports in accordance with § 96 para. 5 of the Veterinary Institute and the competent authorities of the Member States
; Commission guidance and implementing agencies and
legal regulation stipulates the scope of data to be provided in these reports

C) without undue delay response to the request of the Veterinary Institute of
provision of additional information necessary for the evaluation of the
risk-benefit balance of a medicinal product, including the provision of information
volume of sales or prescriptions for the medicinal product;
such information shall also be provided to the competent authorities of the European Union and
Member States

D) providing further information relevant to the evaluation of the risk-benefit balance
medicine Veterinary Institute and possibly
competent authorities of the European Union.

(3) The marketing authorization holder shall immediately inform the Veterinary Institute
about changing the person responsible for pharmacovigilance pursuant to paragraph 1.


§ 96

(1) The marketing authorization holder shall maintain detailed records of all
suspected adverse reactions that are related to the medicinal product
occurred, and that the European Union and in third countries, and these | || information transmitted electronically in accordance with guidelines prepared by the Commission and
Agency; In exceptional cases, upon request of the holder of the marketing authorization
Veterinary Institute decide to give him
holder of the marketing authorization passed this information in any other way.

(2) The marketing authorization holder is required to record and report
Veterinary Institute within 15 days of any suspected cases
incidence of serious adverse events and adverse events in connection with the use
medicine occurred in humans, which
occurred in the Czech Republic, of which the holder is informed, or
can expect that of them should be informed.

(3) The MAH shall ensure that all suspected
incidence of serious unexpected adverse reactions and side effects, which
in connection with the medicinal product occurring in humans, and further
suspected transmission any infectious disease agent
medicinal product, which has occurred on the territory of third countries, were reported by

Commission's guidelines and the agency so that the Agency and the competent authorities
Member States in which the medicinal product is authorized, and
later than 15 days from the receipt of the information.

(4) For medicinal products which have been authorized by Member States on the basis of an opinion
Committee issued before January 1, 1995 in accordance with EU regulation
^ 54) or which have benefited from the procedures of mutual
recognition in accordance with § 41, and medicines that have been applied to the review procedure
^ 53), the MAH further
ensure that all suspected serious adverse reactions occurring
in the European Union, was reported in the format and within the deadlines agreed with
reference Member State or a competent authority acting as reference Member State
such a way that the reference Member State
available. If the reference Member State
Czech Republic, Veterinary Institute, as the competent authority of the reference Member State makes
acts, implementing and analyzing and monitoring such adverse reactions
.

(5) If the decision on the marketing authorization
stated otherwise, given the MAH Veterinary Institute
periodic safety update reports containing the records referred to in paragraphs
1-4

A) immediately at the request of that institution, or

B) at regular time intervals as follows:

First once every six months after authorization until the medicinal
product is first placed on the market in the Czech Republic

Second after the medicinal product is first put on the market in the Czech Republic
, once every six months during the first 2 years
once a year over the next 2 years and at three-yearly intervals;

Periodic safety update reports shall include professional
risk-benefit assessment of the medicinal product.

(6) MAH
submit periodically updated safety reports referred to in paragraph 5 below, the competent authorities
European Union and its Member States under the guidance of the Commission and the agency.

(7) After the issue of the marketing authorization holder may
decision on the registration request to change the intervals of administration
periodic safety update reports in accordance with paragraph 5.

(8) The MAH must
publish information concerning pharmacovigilance in relation to its authorized
medicinal product without giving prior or simultaneous notification
Veterinary Department and any relevant Member State authorities or authorities
European Union. If the MAH
publishes information concerning pharmacovigilance must ensure that
communicated objectively.

§ 97

(1) The Veterinary Institute shall ensure that reports of suspected cases
serious adverse reactions and side effects in
connection with the use of a medicinal product in humans occurred in the territory
Czech Republic, were in accordance with the guidelines of the Commission and the Agency no later
15 days from the day when the Institute receives, and forwarded to the Agency
other Member States; to the Veterinary Institute utilizes electronic
network established by the Agency in cooperation with Member States and the Commission.
In the case where such reports shall Veterinary Institute
person other than the holder of the marketing authorization, the Veterinary Institute shall ensure that the reports on this
informed the marketing authorization holder within 15 days of
, the Veterinary Institute reports received.

(2) for reporting pharmacovigilance of veterinary medicinal products must
marketing authorization holders
use internationally agreed veterinary medical terminology.

(3) Where the Veterinary Institute, as a result of the evaluation of pharmacovigilance data
necessary to suspend, cancel or change
registration, the Agency shall immediately inform the competent authorities
other Member States and the marketing authorization holder. If
to protect public health, urgent action may
Veterinary Institute to suspend the registration of a product and the latest
next working day inform the Agency
Commission and the competent authorities of other Member States. Veterinary Institute receives
well as interim measures, if required by the Commission.


(4) The Veterinary Institute shall proceed in the case of prohibition of supply
veterinary medicinal product, or prohibit its use or withdrawal regulation
veterinary medicinal product on the market according to § 90 par. 4-7
analogy. Veterinary institute such a procedure applies also in the case
if the withdrawal period of a veterinary medicinal product is not
sufficient to ensure that food derived from animals
which the veterinary medicinal product has been administered does not contain residues which | || could pose a risk to consumers' health.

(5) An appeal against the decision to ban the dispensing of veterinary medicinal
product or its use or regulation
Download the veterinary medicinal product on the market does not have suspensive effect.
TITLE VI


INFORM, control activities, measures and penalties
Part 1


Ensuring awareness, control activities and measures taken

§ 98

Provision of information about defects drugs and side effects of medicines


(1) When a risk to public or animal health or environmental hazard
effects of drugs provided by the Institute or the Veterinary Institute
about suspending the use of drugs, suspension of its
marketing prohibiting supply, use or manufacturing
withdrawal or revocation and suspension of registration
manner allowing remote access, and in serious cases that can not be delayed, also
through public media ^ 77)
providers of health services and those providing veterinary care.

(2) If the measure operator under § 23 para. 1 point. b) or
MAH according to § 33 par. 3 point. c) finds
Institute or Veterinary Institute as sufficient to ensure the protection
life and health of people or animals, send the information referred to in paragraph 1
possibly other relevant information for healthcare providers
or to persons providing health care, in a manner allowing remote access
regional authorities, in the event of veterinary Institute also
veterinary administrations. Veterinary authorities are obliged to transmit information received
immediately veterinary facilities under their jurisdiction
if not already Veterinary Institute, referred to in paragraph 1. They
Institute or the Veterinary Institute shall provide such information in a similar way
distributors who are obliged to return immediately to their customers
according to § 77 par. 1 point. d).

§ 99

Published data, data accessible to the public and data protection

(1) The Institute or the Veterinary Institute in its information media published


A) information on significant adverse effects of medicines and drugs
defects or excipients and
urgent safety measures

B) the cancellation and suspension of registration of medicinal products

C) the list of medicinal products registered in the Czech Republic and within
EU resolution on whether the medicines
restricted to prescription or prescription restricted, with the possibility of picking
without a prescription or without a prescription
restrictions or reserved medicines, to ensure the availability of relevant
SPC and package leaflet

D) consumption of medicines in accordance with resolution of the active substance, which
contained in them, and the administration route,

E) list

First licensee for the activity that gave the Institute or Veterinary Institute
, indicating the scope of activities of the respective operators

Second distributors pursuant to § 75 para. 4

Third persons under § 77 par. 5 point. a) points 1-3,

Fourth pharmacies pharmacies providing resolution and mail-order dispensing and
list of people involved in mail-order dispensing into the Czech Republic
Member States

Fifth holders of the certificate of Good Laboratory Practice

6th certificate holders manufacturer of raw materials,

7th ethics committees

8th NIS

F) information

First treatment programs approved by the Ministry of Health,

Second clinical trials, which is allowed to start in the Czech Republic, with the exception
bioequivalence studies and studies in which occurs the first
administration of the active ingredient man


Third granted for parallel imports of medicinal products,

Fourth new requirements of the European Pharmacopoeia,

Fifth authorized hospital exemptions for medicines for advanced
therapy

G) information on the penalties imposed

H) the suspension or termination of placing the medicinal product on the market in the Czech Republic
significantly affecting the provision of health services,

I) a decision on expiry of permission to distribute,

J) criteria for the classification of the medicinal product, taking into account
active substance, the maximum single dose, the maximum daily dose, strength, dosage form
, types of packaging medicine or other circumstances
use of the medicinal product | ||
K) list of exemptions granted authorization for veterinary medicinal products
,

L) information relating to the conditions for the use of immunological veterinary medicinal product
according to § 47 para. 1

M) detailed guidance on the collection, verification and report format
adverse events or reactions, together with decoding procedures for
in cases of serious unexpected adverse events

N) an annual report on its activities

O) information from the registry of mediators including the name or
name, last name, business address and identification number of the person
case of a natural person or the name, registered address and identification number of the person
in the case of a legal person.

(2) The Institute or the Veterinary Institute, according to its competence to make available upon request


A) information on permits issued for activities and certificates unless
been published pursuant to paragraph 1

B) report on the evaluation of medicinal products, with the exception of forming
contents of a trade secret under special legislation ^ 55) and
information about the initiation of administrative proceedings based on applications submitted
authorization or notification of a clinical trial ,

C) information regarding decisions on registration, changes in registration,
renewal, transfer of registration, termination of registration, registration
takeover, parallel imports and other administrative and conclusions
other proceedings under this Act, || |
D) information about the course of individual administrative proceedings and other proceedings
under this Act, including information about the discontinuance of the proceedings; in these cases
Institute or the Veterinary Institute
such information available to the public upon completion of the relevant procedures,

E) summary information on the prices and quantities of individual medicinal
products that were distributed to providers of health services
or persons providing veterinary care or issued pursuant to § 82
operator authorized to dispense medicines || |
F) information from the pharmacovigilance system, or information relating to haemovigilance
while the Institute with regard to the qualifications of the applicant and
purpose use the information to assess the extent of the information provided and may
when providing information to establish the conditions for its further
use in accordance with the guidelines of the Commission and agencies

G) information on ongoing programs
risk management of individual medicines

H) of its working procedures and organizational documents

I) information which clinical trials, including
bioequivalence studies and studies in which occurs the first administration of the active ingredient man
which specific therapeutic programs are under way or have been prematurely terminated, stating
because of their premature termination

J) information about the decisions in the exercise of competence according to § 13 paragraph
. 2 point. h) or pursuant to § 16 para. 2 point. f) issued.

Information under this paragraph may Institute or the Veterinary Institute
also publish in its information media.

(3) The data submitted in the registration process
medicinal product must be without the consent of the registrant disclosed to other persons.
The fact that an application for marketing authorization was submitted
Institute or the Veterinary Institute may be published before the expiry of
only with the consent of the registrant. The Institute or the Veterinary Institute
publicly accessible without delay the marketing authorization together with
leaflet and the summary of product characteristics and determination
any conditions and obligations pursuant to § 31a, § 32 par. 3 and § 32a || | indicating any deadlines for the fulfillment of these conditions and obligations for

Each medicinal product which they have authorized. The Institute or the Veterinary Institute
further publicly accessible without delay the assessment report on the medicinal product
according to § 31 para. 8 of the reasons for their opinion, after deletion of any information
having a commercially confidential nature
under special laws ^ 55). Reason must be processed
separately for each indication. Exposed
report assessing the product according to § 31 para. 8 provides a summary evaluation
treated in a way understandable to the general public, while
summary shall in particular contain information relating to the conditions of use
medicine.

(4) The publication or provision of information about security
serious impact on the health or life of persons or animals in the public interest or
information about the consumptions of medicinal products pursuant to paragraph 1. d)
is not considered a violation of trade secrets under special legal regulations
^ 55).

(5) Data were provided by the Department of distributors according to § 77 par. 1
point. f) and operators authorized to dispense medicines according
§ 82 par. 3 point. d) after processing and provide
published so that in the circumstances it was not possible to identify or determine which persons
the data subject. If they contain such data personal data
subject to this data protection laid down by a special Act ^ 36).

(6) The information resource of the Institute for remote access
is linked to the European web portal for medicines
established in accordance with applicable regulations of the European Union, the procedural
authorization and supervision of medicinal products.
Through information means allowing remote access, the Institute publishes mainly


A) information on medicines authorized under this Act
especially reports on the evaluation of medicinal products, along with their
summary, summaries of product characteristics and the package leaflet, as well as summaries of management plans
risk

B) the list of medicinal products referred to in the directly applicable regulation
European Union governing the procedure for the registration and supervision of medicinal products
,

C) information on the ways of reporting suspected adverse reactions to medicinal products
Institute of healthcare professionals and patients, including
structured forms allowing to report on the Internet
specified in directly applicable EU regulations governing the procedure
registration and supervision of medicinal products.

§ 100

Exchange of information between the competent authorities of the Member States

(1) The Institute or the Veterinary Institute informs the competent authorities of the Member States
information about the requirements for authorization for production or
authorization of medicinal products are met.

(2) At the request of the competent authority of the Member State
Institute or the Veterinary Institute shall notify this office of the content of the inspection report.

(3) If the Institute or Veterinary Institute has received from the competent authority of the Member State
report pursuant to paragraph 2 and disagrees with the conclusions
competent authority of the Member State in which the protocol was created
notify this office of their reasons and, if appropriate, seek
further information. If it is necessary in case of serious differences of opinion
and if it was not possible to reach agreement with the competent authority,
inform the Commission and the Agency Department.

(4) The Institute or the Veterinary Institute Announces Agency
decision on the registration, refusal or cancellation of registration, revocation of decisions
refusal or cancellation of registration, or withdrawing
medicinal product from the market, together with the reasons on which such decisions are based
.

(5) The marketing authorization holder shall immediately notify
Member States in which the relevant product has been authorized or
marketed, measures which suspend the marketing of the medicinal product
on the market or withdraw of the market, stating the reasons for such action;
Institute or the Veterinary Institute shall notify this information to the Agency.

(6) The Institute or the Veterinary Institute shall promptly notify
information about actions taken pursuant to paragraphs 4 and 5, which may affect the protection of public health
in third countries, the World Health Organization and the Agency.


(7) Department provides the competent authorities of other Member States information
associated with serious adverse reactions or serious adverse events
or suspicion on them to ensure that defective
transfusion products and raw materials for further manufacture
will be withdrawn from use and disposed of. If such information
Department receives from the competent authorities of other Member States shall proceed in accordance with § 13 para. 2
point. c) or e).

(8) Institute inserted into a publicly accessible database of European Union designed and administered by the Agency
data

A) the manufacturing authorization issued pursuant to § 62 paragraph. 1

B) distribution authorization issued pursuant to § 75 para. 3,

C) it has issued certificates of good manufacturing practice and good distribution
practice

D) decision on registration of importers, manufacturers and distributors of medicinal substances
.

§ 100a

If the Czech Republic as the first Member State found
suspect that the medicinal product constitutes a serious threat to public
Health Department immediately inform the competent authorities of the Member States and
persons authorized to distribute medicines or give in
Czech Republic this fact, the form of communication
manner specified by Commission guidelines. If the Institute expects that the Czech Republic was
patients given medicinal product for which there is suspicion
serious threat to public health in relation to its use, shall
Department within 24 hours of a public announcement of that fact and carry
necessary measures leading to its withdrawal. Such public announcement
particular contain information on suspected quality defect of a medicinal product or
suspicion that it is a forgery and alerts
related risks.

§ 101
Control activities


(1) During the inspection under this Act, the authorities performing state administration
referred to in § 10 inspectors and inspection according to the order.
Authorization for inspection proves inspector license inspector.

(2) In case of reasonable suspicion of an infringement
under this Act, the Institute or the Veterinary Institute entitled

A) remove the need for compensation samples of medicinal products, starting materials or intermediates
to assess their quality and safety
under this Act and special legislation 79)

B) require other state authorities, Czech Police
and other persons providing personal data necessary to determine
identity of persons suspected of infringement by
this Act for the purpose of instituting administrative proceedings against those
persons under this Act; with these data Institute handled under special legislation
^ 60)

C) identify individuals when administering oral explanation
^ 80); exercise of this right provided by authorized employees
Institute or the Veterinary Institute.

(3) The Institute or the Veterinary Institute supervises compliance requirements
stipulated by this law, notably through checks
carried out repeatedly and at appropriate intervals depending on
risk. Checks may also be unannounced and may be implemented in the form
laboratory testing of samples. To this end, the institute
cooperate with the Agency and by informing on planned and carried
checks and coordinating inspections in third countries.

(4) The inspectors are authorized to monitor compliance with this Act
operators, other persons handling drugs holders
decision on registration of manufacturers and importers of excipients and intermediaries.
In addition, inspectors carry out checks on the premises, records, documents and
of the pharmacovigilance system holders
decision on registration or any bodies that the holder of the registration
used to perform the activities specified in Chapter Five.

(5) In connection with inspection activities, inspectors are authorized

A) suspend the license for persons who have been granted permission by
this Act

B) suspend action in the event of vendors of selected medicinal products, and give
Licensing Office proposal for the suspension of business
or cancellation of trade license ^ 74)

C) suspend the case for control in the sphere of human pharmaceuticals, power

Privileges resulting from a decision issued pursuant to special legal regulations
^ 9), and in the case of control in the sphere of veterinary pharmaceuticals, power
privileges resulting from the authorization to engage in specialized veterinary activities
issued under a special legal prescription ^ 18)

D) to suspend dispensing of transfusion products in a blood bank or transfusion service
,

E) in justified cases, particularly in the case of deceptive labeling
medicinal product to perform its temporary collateral; this measure
familiar inspector inspected person and passes it
official record of the action taken, stating the purpose of ensuring the descriptions and quantities seized
medicines; This is part of the official record
inspection report; after falling reasons measures returns controlled
party secured Medicines intact, or
shall without undue delay controlled person of a process under §
88; This does not affect the provisions of paragraph 2. d); if it is proved that
secured medicinal products comply with the requirements of this Act, return
Institute or the Veterinary Institute inspected person secured medicines in
intact; if it is proved that secured medicines
meet the requirements of this Act, shall Institute or Veterinary Institute
decision on the seizure of a medicinal product; confiscated medicines is
Institute or the Veterinary Institute shall remove according to § 88;
This does not affect the provisions of paragraph 2. d); for the duration of the measures and the
if a decision on the confiscation of the medicinal product does not belong
inspected person for seized or confiscated medicines reimbursement;
If a decision on the confiscation of the medicinal product is controlled
person liable for the costs incurred by the Institute or the Veterinary Institute
related to storage secured
medicinal products and the removal of seized medicines.

The decision referred to in subparagraphs a) to d) is stored in on-site management by
special legal regulation 81). Such a decision can only be made
if the inspected person has seriously violated the conditions
who is authorized to practice the trade license or a decision
issued pursuant to special legislation 71) tied or violated || | seriously obligations under this Act.

(6) The costs of state administration bodies under this Act
incurred by them during their inspection activities, inspected person shall pay
when a check was made at her request, even if
the inspection outside the Czech Republic.

(7) If the Institute deficiencies in the control of the persons to whom
granted a certificate, it may force him to cancel the certificate issued.

(8) If the Institute in the control of the operator conducting nonclinical safety studies
does not respect the principles of good laboratory practice
manner that undermines the validity of studies conducted, informs
Commission. Monitoring compliance with GLP Department
does not, if conducted by a competent authority of another Member State
; In this case, the Institute shall recognize the results of the inspection or follow
under § 100 paragraph. 3. The list of operators conducting nonclinical safety studies
, which was certified on 31 December
each calendar year, and a statement of checks for the preceding calendar
annually to the Department no later than 31 March to the Commission.

(9) If inspection pursuant to paragraphs 1 to 4 or the outcome
control distributor of medicinal products or active substances or
manufacturer of excipients used as starting materials
Department will conclude that the controlled person does not comply legislation or policies and
guidelines of good manufacturing practices or good distribution practices as provided
European Union legislation, it shall notify this information to the Agency.
On a reasoned request by the Institute sends electronic messages about whether
controlled entity complies with the principles and guidelines of good manufacturing practice and
distribution practice, or on whether the marketing authorization holder
complies with the requirements under Title fifth, the competent authority of another Member State
.

(10) If the Department inspection finds that the holder of the registration
does not comply with the pharmacovigilance system as described in

Pharmacovigilance system and responsibilities prescribed in Subpart
fifth, highlights these shortcomings MAH.
Along with this notice informs the Department of the findings
competent authorities of other Member States, the Agency and the Commission and adopt as appropriate
necessary measures, including the application of sanctions.

(11) check the relevant institute carried out in accordance with Commission guidelines, if
were for the kind of checks issued.

§ 102
Batch release


(1) The Institute or, in the case of products referred to in subparagraph f)
Veterinary Institute may require, if deemed necessary in the interest of public health
to MAH

) Live vaccines

B) immunological medicinal products used for primary immunization
children or other risk groups

C) immunological medicinal products used in public health immunization programs
,

D) new immunological medicinal products or immunological
medicinal products manufactured using new or modified technologies or technologies
new for a particular manufacturer, during a transitional period

E) of blood, or

F) immunological veterinary medicinal products

Set before putting into circulation samples of each batch of bulk or
finished medicinal product for testing by the Institute or the Veterinary Institute
, which can also provide testing laboratories through
another person.

(2) If, in the case of application of paragraph 1 has previously given batch
have checks the competent authority of another Member State and
confirmed its compliance with the approved specifications, the Institute or the Veterinary Institute
utilizes its conclusions.

(3) If the Veterinary Institute, after consulting the conclusions
authority of another Member State disagrees with these findings, it may, assuming a
inform with due justification of existing differences Commission
repeat testing .

(4) The Institute or the Veterinary Institute shall ensure that the examination of specimens were
done within 60 days of receipt; in a reasoned case may
Veterinary Institute, provided that informing the Commission
extend testing of the period required. The results of the testing in accordance with paragraph 1
inform the Institute or the Veterinary Institute of the holder of
marketing authorization of a medicinal product within the periods specified in the first sentence.
Part 2

Administrative offenses


§ 103

(1) A legal or natural person commits an administrative offense
that

A) treated with medicines without authorization, approval, authorization or consent
where the law or directly applicable legislation of the European Union
permit, approval, authorization or consent to treatment with drugs
required | ||
B) places on the market a medicinal product subject to mandatory registration under §
25 or the centralized procedure of the European Union under directly applicable regulation
EU-24) without this preparation was
such authorization is granted, or to market a medicinal product in
contrary to the conditions laid down in the decision on registration

C) places on the market counterfeit medicine

D) contrary to § 77a paragraph. 2 mediates human medicines
without registration by the competent authority of the Member State

E) imports from third countries active substance in contravention of § 70 para. 2, or

F) contrary to § 24a para. 2 fails within the time required
data.

(2) A legal or natural person referred to in § 24 para. 1
committed an administrative offense that imports or exports
transfusion product or raw material for further production in conflict with § 24 para. 4 or
informs about the importation from third countries or to realize
exports to third countries according to § 24 paragraph. 8th

(3) A legal or natural person commits an administrative offense
that, as the holder of the marketing authorization
centralized procedure of the European Union

A) fails Institute or Veterinary Institute new information that would
could result in a change to the data or the documentation
medicinal product

B) inform the Institute or the Veterinary Institute on Prohibitions or Restrictions
imposed by the competent authorities of any country in which the medicinal

Product is marketed, or other new information which might influence the evaluation
benefits and risks of medicinal
product

C) fails to comply with another obligation stipulated by a directly applicable regulation
EU-24) regulating the area of ​​manufacture or pharmacovigilance than
which is listed in subparagraphs a) and b).

(4) A legal or natural person commits an administrative offense
that

A) contrary to § 78 para. 1 possesses substances that have anabolic,
anti-infective, anti-parasitic, anti-inflammatory or hormonal
effects or addictive substances or precursors, which can be used for production
veterinary medicines,

B) a person referred to in § 78 para. 2 does not give in conflict with § 78 para. 2
notice or updated notification or in violation of § 78 para. 4
does or does not keep records

C) prepare a medicinal product without having to do so in accordance with § 79 para. 2
entitled,

D) issue or sell medicine without a person to do according to § 82 paragraph
. 2 6 or authorized, or providing mail-order dispensing of medicinal products
without having to do so pursuant to § 84 par. 2 person authorized, or

E) as a person who was the marketing authorization holder fails to fulfill an obligation
withdraw the medicinal product from circulation in accordance with § 34 para. 8th

(5) A legal or natural person as a handler
with drugs commits an administrative offense that

A) treated with medicines conflict with § 7 para. 1 point. b) or §
79 par. 10

B) the provision of medical services used in medicine
conflict with § 8. 1-5 or in conflict with § 8. 5
notifies the prescription or use of an unauthorized medicinal product

C) the provision of veterinary care medicine used
inconsistent with § 9. 1 to 9 and paragraph. 11-15 or used veterinary autogenous vaccine
contrary to § 72 para. 1 or 3,

D) a person involved in the clinical trial fails to comply with the rules of good clinical practice
according to § 56 paragraph. 13 or good clinical veterinary practice
according to § 61 paragraph. 1, or

E) as a submitter treatment program for medicine
subject to the centralized procedure of the European Union fails
inconsistent with applicable regulations of the EU-24) access
patients participating in a treatment program for a given medicinal product in
period between authorization and placing on the market.

(6) The operator commits an administrative offense by

A) contrary to § 23 para. 1 point. b) fails
all available measures to redress or reduce the adverse effects of the drug
or fails all available measures necessary for the implementation
withdrawal of a medicinal product from the market in accordance with § 23 para. 1 point.
E)

B) comply with the notification obligation pursuant to § 23 para. 1 point. b) or c)

C) contrary to § 23 para. 1 point. d) fails to provide the documents necessary for monitoring
consumption of medicines,

D) places on the market, put into circulation or used in the provision of health services
medicine or veterinary care in conflict with § 23 para. 2

E) as an operator conducting nonclinical safety studies of drugs
fails to comply with the rules of good laboratory practice in accordance with § 23 para. 6

F) as the operator that treats human blood, its components,
transfusion products and raw materials for further production

First not ensure compliance with quality and safety in accordance with § 24 para. 1

Second does or does not keep records in accordance with § 24 para. 2, or

Third in the event of serious adverse reactions or serious adverse events
or suspected fulfill the obligation pursuant to § 24 para. 3, or


G) violates the prohibition distribute medicines which went as a
operator of a pharmacy in accordance with § 82 para. 4th

(7) The provider of medical services for which we can according to § 79 para. 2
prepare medicines commits an administrative offense by

A) fails to comply with the conditions or the extent of preparing medicines according to § 79 paragraph
. 1 and 2,

B) fails to ensure the quality of medicinal products prepared by him or perform
rules of good laboratory practice in accordance with § 79 para. 3,

C) fails to notify the commencement or termination of its activities in accordance with § 79 para. 4, or


D) used in the preparation of medicines substances in violation of § 79 para.
8th


(8) The provider of health services for which we can according to § 79 para. 2
point. b) or c) to prepare medicines commits an administrative offense by
do not decrease a person who is responsible for the preparation and handling of drugs
according to § 79 paragraph. 7th

(9) medical service provider commits an administrative offense by the


A) withdraw a medicinal product subject to registration under § 25
inconsistent with § 82 par. 3 point. b)

B) contrary to § 82 par. 3 point. c) disrupt the integrity of the packaging
medicinal product subject to registration pursuant to § 25

C) contrary to § 82 par. 3 point. d) fails or keep records
dispensing of medicines or to provide data on issued
medicinal preparations

D) does not keep records or fails to keep under § 82 par. 3 point. e) or

E) informs the patient identification sign according to § 80

(10) The operator of the pharmacy commits an administrative offense by

A) fails to comply with the requirement for professional prerequisite for handling pharmaceuticals
according to § 79 para. 5

B) contrary to § 79 para. 6 not stop the person responsible for the activities
pharmacy, or ensuring that a chief pharmacist or a pharmacist authorized by him
was for operating a pharmacy in pharmacy always present || |
C) removes the upcoming medicine or active substance and
excipients intended for its preparation from another pharmacy contrary to § 79 paragraph
. 9

D) issue the medicine without a prescription or invalid
prescription contrary to § 82 para. 1, issue or medicine
which according to the marketing authorization issued without a prescription
restrictions inconsistent with § 39 par. 5, issue or medicine that is
by the marketing authorization issued to restricted medical prescription
in conflict with § 39 par. 4, issue or medicine in conflict with §
paragraph 79a. 1

E) issues a medicinal product to another pharmacy or provider of inpatient care in
contrary to § 82 para. 4 or contrary to § 82 par. 3 point. f) fails
all measures necessary to exchange the product for which it was
fault is detected in the quality

F) does not proceed in the dispensing of medicine in accordance with the rules laid
§ 83 paragraph. 1-7,

G) in the dispensing of medicinal products on electronic prescription does not report by
§ 82 central repository of electronic prescriptions that
prescribed medicinal product has already been issued, or

H) if it is also the holder of a distribution authorization violates
obligation to notify when ordering supplies whether the medicine is taken
as the operator of a pharmacy or a distributor according to § 82 para. 3
point. G).

(11) The operator of the pharmacy providing mail-order dispensing
commits an administrative offense by

A) comply with the notification obligation pursuant to § 84 par. 3,

B) contrary to § 85 para. 1, the mail order medicine
unregistered in the Czech Republic or the European Union or the issue
mail order medicine, whose output is subject to medical prescription
or restricted according to § 39 par. 5

C) publish information on mail-order dispensing,
offer medicinal products, their prices and costs associated with the mail-order dispensing
according to § 85 para. 2 point. a)

D) does not provide packing or shipping packages containing medicines
according to § 85 para. 2 point. b)

E) failure by the customer shipment of § 85 para. 2 point. c)

F) does not provide an information service according to § 85 para. 2 point. d)

G) fails to refund the claimed medicinal products pursuant to § 85 para. 2
point. e)

H) fails to comply with conditions for dealing with foreign languages ​​designated
medicinal preparations according to § 86 par. 1, or

I) ensuring that a website providing mail-order pharmacy dispensing
contained information according to § 85 para. 3rd

(12) vendor of selected medicinal products shall commit an administrative offense by
that

A) contrary to § 23 para. 4 point. a) fails to ensure that any natural person
selling reserved medicinal products satisfy the condition
obtain a certificate of professional competence vendor of selected medicinal
for human or veterinary medicinal přípravkypřípravků,

B) contrary to § 23 para. 4 point. b) comply with the notification obligation or
fails to comply with the rules of good practice of vendors of selected medicinal
products


C) contrary to § 23 para. 4 point. c) sold other than dedicated
medicinal product

D) exclude them from selling reserved medicinal product according to § 23 para. 4
point. d) points 2-6 or

E) contrary to § 23 para. 4 point. f) removes a dedicated medicine
from persons other than manufacturers or distributors of those products
or does not keep records or fails to keep pursuant to § 23 para. 4 point. G).

(13) A legal or natural person commits an administrative offense
that, as the holder of the marketing authorization
contrary to the directly applicable EU regulation governing
medicinal products for pediatric use 82 ^ )

A) not take into account the pediatric indication in the summary of product characteristics or the
leaflet within 2 years from the date of registration,

B) fails to comply with the obligation to periodically update safety reports
medicinal product with respect to information relating to the assessment of the effectiveness
risk management system and the results required special
studies

C) fails Institute's annual report on progress with pediatric studies in accordance with the decision
Agency agreeing the pediatric investigation plan and granting a deferral
or does not comply with such a decision
agency

D) fails Institute all studies specified by him relating
use of an authorized medicinal product in the pediatric population, or
such studies do not submit to the Institute within six months from the date of completion
,

E) violates another obligation stipulated by a directly applicable regulation
European Union governing medicinal products for pediatric use ^ 82)
or administrative action taken thereunder.

§ 104

(1) A manufacturer of medicinal products shall commit an administrative offense by
in conflict with § 64 point. j) fails in the manufacture of medicines
permission to manufacture or rules of good manufacturing practice.

(2) The operator of a blood center shall commit an administrative offense by
that contrary to § 67 para. 4 and § 64 point. j) fails when
manufacture of transfusion product to manufacturing authorization or rules of good manufacturing practice
.

(3) The operator of a control laboratory shall commit an administrative offense by
that, contrary to § 69 par. 3 and § 64 point. j) fails in verifying
quality of medicinal products, active substances, excipients, intermediates or
packaging, the manufacturing authorization or rules of good manufacturing practice
.

(4) The manufacturer of medicinal products or operator of a blood
Services commits an administrative offense by not applying in advance for a change
permission to manufacture according to § 64 point. h) regarding
manufacturer of medicinal products, or according to § 67 para. 4 and § 64 point. h) regarding
operator transfusion service.

(5) The manufacturer of medicinal products or operator control laboratory
pursuant to § 69 par. 3 fulfills certain obligations
manufacturer of medicinal products, commits an administrative offense by

A) does not ensure implementation of manufacturing activities related to
registered medicinal products in accordance with § 64 point. b)

B) never faded department of quality control or assurance conditions for its
under § 64 point. d) or does not have a professionally qualified
person responsible for quality control according to § 64 point. e) or

C) contrary to § 64 point. q) fails to ensure that manufacturing processes have been validated
.

(6) The provider of health services, which includes blood bank
or medical service provider is providing transfusion services
committed an administrative offense that

A) does or does not maintain records and documentation according to § 67 para. 4
point. e)

B) establishes the system for identifying donors according to § 67 para. 4 point. f)

C) comply with the notification obligation pursuant to § 67 para. 4 point. g) or

D) does not create or maintain a system for monitoring and evaluation
adverse events, adverse reactions, accidents and errors pursuant to § 67 para. 4
point. h).

(7) The manufacturer of medicinal products shall commit an administrative offense by

A) fail to notify change of data pursuant to § 63 para. 7

B) does not provide services of a qualified person of the manufacturer according to § 64 point. a)

C) if imported medicines, fails in their import
meet the requirements under § 64 point. w)

D) contrary to § 71 para. 2 of veterinary autogenous vaccine without

Prescription for veterinary autogenous vaccine or in the production of prescription
fails to comply or not comply with the restrictions on the production of veterinary autogenous vaccines
according to § 71 para. 4 or 5

E) comply with the notification obligation prior to the commencement of production
veterinary autogenous vaccines according to § 71 para. 6

F) manufactures or puts into circulation a medicated feed in conflict with § 73 para.
1

G) in contravention of § 73 para. 8 produces or puts into circulation
medicated feed, without conditions pursuant to § 73 para. 7

H) above does not manufactured medicated feed separate data set for
signs of medicated feeds according to § 74 para. 5, or

I) a manufacturer authorized distributor perform activities according to § 75 paragraph
. 5 notifies in advance the commencement of distribution in the Czech Republic or
not provide data and information in accordance with § 75 para. 4th

(8) The operator of a blood center shall commit an administrative offense by
that

A) does not provide services of a qualified person of the transfusion service
according to § 67 para. 4 point. a)

B) removes or distributing a transfusion product contrary to § 67 para. 4
point. k)

C) distributes or delivers a transfusion product contrary to § 67 para. 5
point. b)

D) contrary to § 67 para. 8 divulge Institute data concerning the qualified person
transfusion service and the persons who carry out activities
qualified person of the transfusion service or

E) contrary to § 67 para. 4 point. l) fails to comply with the obligation referred to in § 83 paragraph
. 6 point. a) and b).

(9) The provider of health services, which includes a blood bank, a
commits an administrative offense that

A) fails to meet the quality system and good manufacturing practice
according to § 68 para. 1 point. a) or

B) does not provide services of a qualified person of a blood bank pursuant to § 68 para. 1
point. C).

(10) The operator of a control laboratory shall commit an administrative offense
by not applying in advance for permission to change the activity
control laboratory under § 69 para. 4th

(11) The operator of a blood center shall commit an administrative offense
by conducting immunization in conflict with § 67 para. 5 point. d).

(12) The manufacturer, having been granted an exemption hospital,
commits an administrative offense if it breaches any of its obligations under § 49b
paragraph. 1 or 3.

(13) Producer human medicines commits an administrative offense
that

A) fulfill any of its obligations under § 64 point. l) am)

B) contrary to § 64a paragraph. 1 point. a) before removing or covering
protective elements verifies that the medicinal product concerned is authentic and that
it has not been tampered with.

§ 105

(1) A manufacturer of medicinal substances commits an administrative offense by

A) immediately notifies the Veterinary Institute initiation of action under §
69b

B) notifies the Veterinary Institute data necessary to ensure their cooperation
according to § 69b or

C) fails to comply with the rules of good manufacturing practice for active substances
according to § 70 para. 1st

(2) Distributor commits an administrative offense by

A) held parallel import of a medicinal product in conflict with § 45 para.
1

B) distribute medicated feed from Member States contrary to § 73 paragraph
. 3

C) contrary to § 75 para. 1 point. a) distributing unregistered medicines
products, unless the distribution of medicines in accordance with § 75 para. 1
point. b)

D) as the holder of a distribution authorization granted by the competent authority
another Member State notifies in advance the commencement of distribution in the Czech Republic
or fails to provide data and information in accordance with § 75 para. 4

E) requests in advance to change the distribution authorization pursuant to § 76 par. 3,

F) contrary to § 77 par. 1 point. b) take a medicine from another
person than from a distributor or manufacturer, or remove it from pharmacies, without
was the return of medicine that the pharmacy added

G) gives medicine a person other than the person referred to in § 77 par. 1
point. c)

H) has developed an effective system to ensure the withdrawal of a medicinal product from circulation
or transmit specified information to their customers according to § 77 paragraph
. 1 point. d) or distributor with a range of permits covering
distribution of active ingredients and excipients in conflict with § 77 par. 5
point. c) has developed an effective system to ensure the withdrawal of the active substance

Or excipients from circulation or transmit the information set out its
customers

I) does not provide data on the volume of distributed medicaments by §
77 par. 1 point. f)

J) inconsistent with § 77 par. 1 point. g) fails in the distribution rules
good distribution practice

K) inconsistent with § 77 par. 1 point. i) imports a medicinal product from a third
country

L) delivers the active substance or excipients
person authorized to prepare medicinal products in contravention of § 77 par. 5 point. a)

M) contrary to § 77 par. 1 point. m) review
checking the safety features on the outer packaging, whether received Medicinal Products
not counterfeit, or in contravention of § 77 par. 1 point. o) inform the Institute of
medicine who has received or was offered and on which
found that it is a counterfeit human medicine

N) inconsistent with § 77 par. 1 point. j) verifying whether the supplying distributor
compliance with good distribution practices

O) inconsistent with § 77 par. 1 point. k) verifies whether the manufacturer of the medicinal product
holds a valid permit to manufacture,

P) inconsistent with § 77 par. 1 point. l) verifies whether the intermediary
meets the statutory requirements, or

Q) the documentation accompanying the medicinal product does not contain information pursuant to §
77 par. 3rd

(3) The producer of medicines or distributor commits an administrative offense
that contrary to § 74 para. 7 delivers medicated feed person
is not listed as a recipient of medicated feed in the Code for
medicated feed.

(4) The holder of parallel import authorization commits an administrative offense
that

A) does not maintain records in accordance with § 45 para. 7 point. a)

B) failing to stop dispensing or marketing of parallel imported medicinal product on the market
according to § 45 para. 7 point. a)

C) does not reflect a change in the authorization of the reference product for parallel import
according to § 45 para. 7 point. a)

D) contrary to § 45 para. 7 point. a) used for the treatment
parallel imported medicinal product service person other than the permit holder
manufacturing

E) above does not repackaged medicine according to § 45 para. 7 point. b)

F) fails to cooperate pursuant to § 45 para. 7 point. c)

G) fails to notify the marketing authorization holder of the reference product for parallel import
intention to launch a parallel import or failed to provide a sample
parallel imported medicinal product in accordance with § 45 para. 7 point. d)
and

H) failure pharmacovigilance according to § 45 para. 7 point. E).

(5) The MAH commits an administrative offense by the


A) comply with the obligation imposed on him by the marketing authorization pursuant to § 32 paragraph
. 3 or 4,

B) not introduce changes or inform the Institute or the Veterinary Institute in accordance with §
33 paragraph. 1

C) comply with the notification obligation pursuant to § 33 para. 2, 4, or 5,

D) contrary to § 33 par. 3 point. a) fails to ensure that the properties
authorized medicinal product or current documentation for him
match the documentation, or does not keep records of medicines,

E) inconsistent with § 33 par. 3 point. c) fails
all available measures to redress and to limit the adverse effects
medicine or implemented or notifies
implement measures to ensure that a replacement medicine or
fails to complete withdrawal of the medicinal product from the market its removal

F) fails to comply with letters rogatory from the institution or fails to cooperate
according to § 33 par. 3 point. d) or fails to notify the competent institution
suspicion of occurrence of quality defects of medicinal products or adjuvants according
§ 33 paragraph. 3 point. i)

G) failure to implement and maintain the system guaranteeing the traceability records or
or storage conditions are observed
promotional sample of a medicinal product according to § 33 par. 3 point. f)

H) contrary to § 33 par. 3 point. g) point 1 shall not establish or operate
publicly accessible professional information service or at the
operation does not set out the information

I) failure of a medicinal product pursuant to § 33 par. 3 point. g)
point 3,

J) failing to submit a sample of the product packaging according to § 33 par. 3 point. h)

K) requests in advance of the change of registration according to § 35 para. 1

L) transferring registration in conflict with § 36 para. 1


M) in contravention of § 35 para. 5 fails to comply markings on the outer and inner packaging
medicine or leaflet with
approved summary of product

N) does not provide services of a person responsible for pharmacovigilance according to § 95 paragraph
. 1, in the case of veterinary medicinal products

O) informs about changing the person responsible for pharmacovigilance according to § 95 paragraph
. 3, in the case of veterinary medicinal products

P) keeps track of all suspected adverse reactions according to § 96 paragraph
. 1, in the case of veterinary medicinal products

Q) comply with the notification obligation pursuant to § 96 para. 2, 3, or 4, in the case of
veterinary medicines

R) fails to submit periodically updated safety report pursuant to § 96 paragraph
. 5 or 6, in the case of veterinary medicinal products

S) communicate information relating to pharmacovigilance concerns in relation to its
medicine in conflict with § 96 para. 8, in the case of veterinary medicinal products
,

T) does not operate a pharmacovigilance system in accordance with § 91 para. 1
or in contravention of § 91 para. 3 does not perform regular audit
pharmacovigilance system, or information about the audit findings not inserted into the basic
pharmacovigilance system, or informs about the change
according to § 91 para. 2 point. b) or keep documentation pursuant to § 91 paragraph
. 2 point. f) or the proceeds of pharmacovigilance
contrary to the instructions of the competent authority under § 91 para. 4, in the case of Medicinal
products

U) in contravention of § 91 para. 2 point. a) does not disclose or on request
pharmacovigilance system master file or contrary to § 91 paragraph
. 2 point. c) does not operate or does not update the risk management system
case of human medicinal products

V) impact of the following measures in accordance with § 91 para. 2 point. d) or following
pharmacovigilance data in accordance with § 91 para. 2 point. e) or inform about
public announcement on pharmacovigilance concerns according to § 93 paragraph.
3 or fails to ensure that information to the public and how they provide
meet the conditions pursuant to § 93 paragraph. 3, in the case of human
medicines

W) has qualified person responsible for pharmacovigilance pursuant to § 91a paragraph
. 1 or divulge her name and contact information in accordance with § 91a
paragraph. 2 or data updated in accordance with § 91a paragraph. 4
appoint or to request a contact person pursuant to § 91a paragraph.
3 or contrary to § 93a paragraph. 1, 2 and 5 to accept or send any messages
or does not have procedures for obtaining data in accordance with § 93a paragraph.
4 or uncooperative in obtaining additional information under § 93a paragraph.
4 or § 93a paragraph. 6, in the case of human medicinal products

X) in contravention of § 93j paragraph. 1 fails to report non-interventional post-authorization safety studies
or progress report or send
final report or inform the Institute in advance of the opening
non-interventional post-authorization safety studies according to § 93j paragraph . 1 or
provides financial compensation in contravention of § 93j paragraph. 2 or contrary to § 93j paragraph
. 4 performs non-interventional post-authorization safety studies
promoting the use of a particular product or requests a change to the marketing
according to § 93j paragraph. 5 or contrary to § 93j paragraph. 3
followed, assessment or disclose information obtained during the execution
non-interventional post-authorization safety studies, in the case of human medicinal products
.

(6) The sponsor commits an administrative offense by

A) does not provide liability insurance against damages pursuant to § 52 paragraph.
3 point. f)

B) commence the clinical trial contrary to § 55 paragraph. 1, or according to § 60 paragraph
. 3, in the case of clinical trials of veterinary medicinal products

C) informs the initiation of a clinical trial pursuant to § 55 par. 8,

D) comply with the notification obligation pursuant to § 56 par. 1 point. a) or paragraph.
5 or 6

E) take immediate measures to protect the subjects or
informs on new facts and the measures taken according to § 56 paragraph
. 3

F) evaluated and updated investigator's brochure
according to § 56 Para. 4

G) does not maintain documentation pursuant to § 56 par. 7

H) it does or does not provide the records according to § 58 par. 3,

I) fails to provide information pursuant to § 58 para. 8

J) failing to report suspected unexpected serious adverse reactions
according to § 58 para. 4 or 5

K) fails to inform the investigator according to § 58 par. 7


L) does not submit an application for change of the sponsor pursuant to § 59 para. 1 or
notifies the change of the sponsor pursuant to § 59 par. 3,

M) failure to conduct the clinical trial according to § 61 paragraph. 2 point.
A)

N) fails to comply with notification obligation pursuant to § 61 paragraph. 2 point. b) or

O) fails to provide the investigator with medicines or keep their sample
according to § 61 paragraph. 2 point. C).

(7) The importer, manufacturer or distributor of drugs for use in human medicines
commits an administrative offense by

A) contrary to § 69a paragraph. 1 notifies the Department of their activities within the
time before the intended commencement of activity or

B) informs the Institute of any changes in the information included in the notice
pursuant to § 69a paragraph. 4th

(8) The provider of human medicinal products shall commit an administrative offense by
that

A) mediates human medicinal products contrary to § 77a paragraph. 1

B) fails to notify the Department of any change of information in the application pursuant to § 77a paragraph
. 4th

§ 106

(1) Entrepreneurs as a QP of the manufacturer
medicines commits an administrative offense that

A) contrary to § 66 para. 1 fails to ensure that each batch of medicinal
product has been manufactured and checked in accordance with this Act,
dossier and the marketing authorization, or in violation of § || | 66 para. 3 of this fact certifies in a register or equivalent
document provided for that purpose, or

B) contrary to § 66 para. 4 fails to ensure that in the manufacture of medicinal products for human
compliance with the requirements of good manufacturing practice or
compliance with the documentation.

(2) Entrepreneurs is a qualified person
blood center commit an administrative offense by not ensuring the collection,
testing or processing of each unit of blood and blood components or
control, release, storage or
distribution of each unit of a transfusion product or raw material for further processing in accordance with § 67 para. 7
point. and).

(3) Entrepreneurs like trying commits an administrative offense
that

A) conducting clinical trials on persons for whom it is according to § 52 paragraph
. 2 banned

B) take immediate measures to protect the subjects according to § 56 paragraph
. 3, or

C) does not maintain documentation of clinical trial according to § 56 paragraph. 7th

(4) Entrepreneurs as a veterinarian
commits an administrative offense by

A) inconsistent with § 48 par. 3 takes the veterinary medicinal product referred to in
§ 48 para. 2

B) as an attending veterinarian does not conflict with § 48 para. 6
records on import of veterinary medicinal products imported pursuant to § 48 paragraph
. 2, or does not maintain these records,

C) issue a prescription for veterinary autogenic vaccine contrary to § 71 paragraph
. 2

D) issue a prescription for medicated feed in conflict with § 73 para. 1 or
§ 74 paragraph. 1, or

E), as the attending veterinarian prescribes medicated feed
contrary to § 74 para. 4th

(5) Entrepreneurs are a healthcare worker commits an administrative offense
that

A) comply with the notification obligation pursuant to § 93b paragraph. 1 point. a) or

B) fails to cooperate or make available documentation pursuant to § 93b
paragraph. 1 point. b).

§ 107

(1) An administrative offense shall be fined up

A) 100 000 CZK, for an administrative offense pursuant to § 106 para. 3 point. c)
or § 106 para. 5 point. b)

B) 300,000 CZK, for an administrative offense pursuant to § 103 paragraph. 1 point. f) §
103. 4 point. b) § 103. 5 point. b) § 103. 6 point. c) §
103. 7 point. a) to c), § 103. 10 point. c), e) or g), § 103, paragraph
. 11 point. a), g) and h), § 103. 12 letter. d) § 104. 7
point. a) § 105 para. 2 point. e) or l), § 105 para. 4 point. a), c) or
e) to h), § 106 para. 1 or 2, § 106 para. 3 point. a) or b)
or § 106 para. 4 and § 106 para. 5 point. a)

C) 2,000,000 CZK, for an administrative offense under § 103. 5 point. a)
§ 103. 6 point. e) § 103. 7 point. d) § 103. 8 or 9, §
103. 10 point. a), b), d) or f), § 103. 11 point. b) to f)
or i), § 103. 12 letter. a) to c) or e), § 104. 5 point. b)
or c), § 104. 7 point. h) or i), § 104. 9 and 10, § 104

Paragraph. 13, § 105 para. 2 point. m) to p), § 105 para. 4 point. b) or d)
§ 105 paragraph. 5 point. c), g), j), o), w) or x) or § 105 para. 6 point.
C), d), f), h) to l), n) or o) or § 105 para. 7 or 8,

D) 5,000,000 CZK, for an administrative offense under § 103. 2, § 103, paragraph
. 4 point. a), c), d) or e), § 103. 5 point. c) or d), § 103, paragraph
. 6 point. b), d) or f), § 103. 10 point. h), § 104. 4, §
104, paragraph. 5 point. a) § 104. 6, § 104. 7 point. d) to g), §
104 par. 8, § 104. 11 and 12, § 105 para. 1 or paragraph. 2 point.
A) to d), f) to h), i) to k) or q), § 105 para. 3 or paragraph. 5 point.
H), k), l), m) q) r) s) t) u) v) or § 105 para. 6 point. b), e), g
) or m)

E) 20,000,000 CZK, for an administrative offense pursuant to § 103 paragraph. 1 point. a)
e), § 103. 3 point. a) to c), § 103. 5 point. e)
§ 103 paragraph. 6 point. a) or g), § 103. 13, § 104. 1-3, § 104, paragraph
. 7 point. b) or c), § 105 para. 5 point. a), b), d), e), f), i)
n) or p) or § 105 para. 6 point. and).

(2) An administrative offense pursuant to § 106 para. 1 to 3 can also be imposed ban
activities, for up to 2 years.

§ 108

(1) A person who commits an offense that

A) treated with medicines without authorization, approval, authorization or consent
where the law or directly applicable legislation of the European Union
permit, approval, authorization or consent to treatment with drugs
required | ||
B) importing or exporting a transfusion product or raw materials for further manufacture
contrary to § 24 para. 4 or inform about the importation
from a third country or for exportation to third countries according to § 24 paragraph. | || 7

C) places on the market a medicinal product subject to mandatory registration under §
25 or the centralized procedure of the European Union under directly applicable regulation
EU-24) without this preparation was
such authorization is granted, or to market a medicinal product in
contrary to the conditions laid down in the decision on registration

D) contrary to § 78 para. 1 possesses substances that have anabolic,
anti-infective, anti-parasitic, anti-inflammatory or hormonal
effects or addictive substances or precursors that can be used for production
veterinary medicinal products without being authorized to do so,

E) prepare a medicinal product without having to do so in accordance with § 79 para. 2
entitled,

F) issues or sells a medicine without having to do so pursuant to § 82 para. 2 or 6
entitled to, or providing mail-order dispensing medicines without
person to do so under § 84 par. 2 authorized or as a person who was
MAH, fulfill the obligation
withdraw the medicinal product from circulation in accordance with § 34 para. 8, or

G) places on the market counterfeit medicine.

(2) A natural person as a handler with drugs commits an offense
that

A) treated with drugs contrary to § 7 para. 1 point. b) or § 79 para. 10
or prescribe medicine prescription with limitations
inconsistent with § 39 par. 4, or when prescribing medicines
proceeds contrary to § 80 paragraph. 1,

B) the provision of medical services used in medicine
conflict with § 8. 1-5 or in conflict with § 8. 5
notifies the prescription or use of an unauthorized medicinal product

C) the provision of veterinary care medicine used
inconsistent with § 9. 1 to 9 and paragraph. 11-15 or used veterinary autogenous vaccine
contrary to § 72 para. 1 or 3,

D) a person involved in the clinical trial fails to comply with the rules of good clinical practice
according to § 56 paragraph. 13 or good clinical veterinary practice
according to § 61 paragraph. 1, or

E) as a submitter treatment program for medicine
subject to the centralized procedure of the European Union fails
inconsistent with applicable regulations of the EU-24) access
patients participating in a treatment program for a given medicinal product in
period between authorization and placing on the market

F) prescribe a medicine containing cannabis for therapeutic use in
contrary to § 79a paragraph. 1st

(3) A person who is a qualified person of a manufacturer of medicinal products
commits an offense that

A) contrary to § 66 para. 1 ensures that each batch of medicinal

Product has been manufactured and checked in accordance with this Act,
dossier and the marketing authorization, or in violation of §
66 para. 3 of this fact certifies in a register or equivalent document provided for
for this purpose, or

B) contrary to § 66 para. 4 fails to ensure that in the manufacture of medicinal products for human
compliance with the requirements of good manufacturing practice
, or compliance with the documentation.

(4) A person who is a qualified person of the transfusion service
commits an offense by not ensuring the collection, testing or processing
each unit of blood and blood components or control
release, storage or distribution of any
unit of transfusion product or raw material for further processing in accordance with § 67 para. 7 point. and).

(5) A natural person as an examiner commits an offense that

A) conducting clinical trials on persons for whom it is according to § 52 paragraph
. 2 banned

B) take immediate measures to protect the subjects according to § 56 paragraph
. 3

C) does not maintain documentation of clinical trial according to § 56 paragraph. 7, or


D) fails to comply with the principles of good clinical practice according to § 56 paragraph. 13 or
good clinical veterinary practice according to § 61 paragraph. 1st

(6) A person who is a veterinarian commits an offense that

A) inconsistent with § 48 par. 3 takes the veterinary medicinal product referred to in
§ 48 para. 2

B) as an attending veterinarian does not conflict with § 48 para. 6
records on import of veterinary medicinal products imported pursuant to § 48 paragraph
. 2, or does not maintain these records,

C) issue a prescription for veterinary autogenic vaccine contrary to § 71 paragraph
. 2

D) issue a prescription for medicated feed in conflict with § 73 para. 1 or
§ 74 paragraph. 1, or

E), as the attending veterinarian prescribes medicated feed
contrary to § 74 para. 4th

(7) A natural person as a health worker commits an offense that


A) comply with the notification obligation pursuant to § 93b paragraph. 1 point. a) or

B) fails to cooperate or make available documentation pursuant to § 93b
paragraph. 1 point. b).

(8) An offense may be fined up

A) 100,000 CZK, if it is a misdemeanor pursuant to paragraph 5. c)
or paragraph 7, letter. b)

B) 300,000 CZK, if it is a misdemeanor pursuant to paragraph 2. b)
paragraphs 3, 4 or paragraph 5. a) or b) of paragraph 6 or paragraph 7, letter.
A)

C) 2 000 000 CZK, if it is a misdemeanor pursuant to paragraph 2. a)

D) 5,000,000 CZK, in the case of an offense under subsection 1. b) or d)
f), paragraph 2. c) or d) or paragraph 5. d)

E) 20,000,000 CZK in the case of an offense under subsection 1. a), c) or
g) or paragraph 2. E).

(9) for an offense under paragraphs 3 to 5 can also be imposed ban on activities, and
up to 2 years.

§ 109

(1) A legal person for an administrative delict if it proves that
made every effort that could be required to breach
legal obligations prevented.

(2) In assessing the fine legal person takes into account the seriousness
administrative offense, especially the manner of its commission and its consequences and
circumstances under which it was committed.

(3) The liability of a legal person for an administrative tort shall expire if
administrative authority did not commence proceedings within two years, when he learned about it,
no later than 5 years from the date on which it was committed.

(4) Administrative offenses as the first instance

) Of the Constitution, in the case of administrative offenses specified in § 13 para. 2 point. i)

B) The Ministry of Health, in the case of administrative offenses specified in § 11
point. e)

C) Veterinary Institute, in the case of administrative offenses specified in § 16 para. 2
point. g)

D) regional veterinary administration, in the case of administrative offenses specified in § 17
point. c)

E) The Ministry of Interior, Ministry of Justice and Ministry of Defence
, in the case of administrative offenses health providers in
scope of these ministries.

(5) The liability for conduct that occurred in the business of a natural person
^ 83) or in direct connection therewith, shall be subject to the provisions of this
Act on liability and sanctions to legal persons.

(6) Income from fines is the income of the state budget.
TITLE VII

COMMON PROVISIONS


§ 110

Method and reimbursement of pharmaceuticals


The payment of drugs from public health insurance and the amount
determined by special legislation ^ 7).

§ 111
Delegated Powers


The competence of regional bodies under this Act function
delegated powers.

§ 111a

Ministry of Defence

(1) The Ministry of Defence may in its field
derogate from this law when the security of the Armed Forces of the Czech Republic
drugs, in the case of a declaration of war or a state of emergency or
during their posting abroad in their

A) distribution and control, while complying with the requirements of effectiveness,
safety and quality of medicines prescribed by this Act;
possibly can after the execution of laboratory inspections extend the shelf life of the medicinal product
and

B) use in cases of life-threatening when it is not appropriate
authorized medicinal product is distributed or not in circulation.

(2) Liability for damage caused by the procedure referred to in paragraph 1 shall not be exempt
.

§ 112
Reimbursement


(1) The execution of expert activities upon request and other professional tasks stipulated by this Act
collected by the Institute or the Veterinary Institute
compensation expenses.

(2) A person at whose request the expert activities are performed
is required to pay the expenses incurred by the Institute or Veterinary Institute
when performing these tasks. The implementing regulation lays down the amount of compensation
costs of expert activities carried out at the request of the scope
Institute or the Veterinary Institute for individual types of applications and expert activities
associated with the duration of registration of medicinal products. The holder of
authorization also covers the costs of activities of the Institute and the Veterinary Institute
associated with the duration of registration of medicinal products by
annual maintenance fees, so that by the end of the calendar year is required to pay an annual
maintenance payment for the following calendar year. If
MAH obligation to pay this payment
not meet the deadline, the Institute or the Veterinary Institute invites him to his
additional payment within 15 days of receiving the call. For the calendar year,
in which authorization has been granted, the maintenance fee reimbursed.
Where no annual maintenance fee paid within the period specified for
additional payment, the marketing authorization holder is obliged to pay
payment plus 50%.

(3) The Institute or the Veterinary Institute

A) is entitled to request from the person at whose request the expert
tasks to be performed, a reasonable advance payment or reimbursement of expenditure and advance
if it is clear that it will be implemented and what will be the amount, or

B) remitted request reimbursement or part of the case of a takeover
registration or acts for the execution of the public interest or
may have particularly significant implications for a wider range of people, especially jde- If
a

First Medicinal Products for orphan

Second medicinal products intended exclusively for use by persons under 18 years

Third veterinary medicinal products intended for use in a minor species
animals or minority indications that have been determined in accordance with the Commission's guidelines and
agencies disclosures in the information media
Veterinary Institute, or

Fourth operations carried out at the request of entities that are subject to support by
directly applicable EU-84).

(4) The Institute or the Veterinary Institute returned to the applicant

A) reimbursement of the full amount if

First the applicant has reimbursed the costs without being obliged to do, or

Second the required expert activity was initiated

B) at the request of a proportion of the compensation to be paid expenses corresponding
professional acts that were pending completion of the proceedings conducted or

C) the difference between the amount paid and the amount of reimbursement of expenses for reimbursement of expenses set
implementing regulation pursuant to paragraph 2.

(5) Reimbursement of expenses under paragraph 1 are not income budget by
special legal regulation 85) and are receiving special account
Institute or the Veterinary Institute. On this account are income
budget under a special legal regulation 85), regards extrabudgetary resources
which uses the Institute or Veterinary Institute directly to ensure
its activities under this Act or under special

Legislation ^ 99), unless this activity to ensure the necessary
range from budgetary resources, unless otherwise provided by law.

(6) The Institute or the Veterinary Institute, according to its competence is also
entitled to claim reimbursement for the execution of expert activities from
persons who breach or non-fulfillment of the obligations laid down by
law or regulation thereunder caused necessity
perform such acts.

(7) An implementing regulation lays down the definition of compensation expenses
way of submission of applications for remission or reimbursement of costs or its
part of a range of documentation submitted with such requests.
TITLE VIII


TRANSITIONAL AND FINAL PROVISIONS

§ 113
Transitional provisions


(1) Management, has not been legally completed before the effective date
force of this Act shall be completed pursuant to existing legal regulations
. If the request for renewal of the registration
under the existing legislation received by the competent
Constitution, preparation for authorized until the day when the
decision on the application for renewal of the registration
.

(2) If the validity of the marketing authorization for the extended management
commenced after 30 October 2005 and completed the entry into force of this Act
, is considered a marketing authorization extended by this Act and
it is valid for an unlimited period.
Institute or the Veterinary Institute may, however, on justified grounds relating to pharmacovigilance
may in this case the procedure for renewal of the authorization
decide on an additional extension for a further five years;
such a decision may, however, be taken only once. Provisions of the first sentence and second
does not prejudice the possibility to cancel or suspend the registration of the grounds listed in §
34 paragraph. 5 or 6.

(3) The marketing authorization holder shall wrapping medicinal product
registered under the existing regulations into line with the requirements
this Act and its implementing regulations, no later than 5 years from the date
entry into force of this Act and this part of the amendment
registration or renewal of the authorization.

(4) The marketing authorization holder shall ensure that the data package
information for a medicinal product authorized according to existing regulations
made available to the blind and visually impaired in accordance with § 37 para. 3
within 3 years from the date of the entry into force of this Act.

(5) for medicinal products authorized before the entry into force of this Act
period of 3 years according to § 34 par. 3 counted from the date of entry into force of this Act
.

(6) The holder of a marketing authorization for a medicinal product meeting
conditions specified in § 30 paragraph. 1 to 3 and registered in accordance with existing regulations
request no later than 31 October 2010 on the variation of this medicine
so that the registration was in compliance with the requirements
laid down in this Act for the registration of traditional herbal medicinal product
. Failing that, the registration of this medicinal product
day of November 1, 2010 expires.

(7) The operator of a medical device that the effective date of this Act provides
blood bank activity under § 4 para. 7
notify this fact to the Institute within three months from the effective date of this
Act.

(8) Quality System as set out in § 13 para. 3 point. l) and § 16 para. 3
point. j) Institute and the Veterinary Institute shall establish not later than 1 year from the date
entry into force of this Act.

(9) The obligation to pay the annual maintenance fee pursuant to § 112. 2
arises for the first time for the calendar year 2008.

(10) Reimbursement of expenses will be waived in the case of an application for registration
veterinary medicinal product submitted no later than 31 December 2008
if there is a transfer of veterinary medicine ^ 18)
into the category of veterinary medicinal products .

(11) Institute and the Veterinary Institute, established under the former law, they are
administrative authorities with powers under this Act.

(12) Under the provisions of dispensing medicines without medical prescription
Limited (§ 39 par. 1 and 4) progresses from 1 January 2009.

(13) The Institute will establish a central repository of electronic prescriptions
no later than 1 year from the effective date of this Act.

§ 114
Enabling provisions



(1) The Ministry of Health shall issue a decree to implement § 4 para. 7, § 24 paragraph
. 2, 3, 4, 8 and 9, § 67 para. 2 and 4, § 67 para. 5 point. b) c)
§ 67 paragraph. 7 point. b) § 67, para. 10 and 11, § 79a paragraph. 1 and § 82 para. 2
point. d) and e).

(2) The Ministry of Health and Ministry of Agriculture
issue regulations to implement § 2 par. 2 point. c) § 5 para. 4, § 8.
1 and 5, § 23 para. 5, § 23 para. 6, § 26. 5 point. n), § 26 par. 7, §
27 paragraph. 5, 7, 11 and 12, § 28 para. 1 point. c) § 28 para. 3, § 29 para.
2, § 30. 3, § 32 par. 3, § 33 par. 3 point. g) section 3, § 34 para.
1, § 36 para. 1, § 37 para. 1 to 3, 5 and 6, § 38, § 39 par. 5, § 40 paragraph
. 2 point. f) § 40 para. 3, § 44 par. 3 and 9 point. f) § 45 para. 7
point. b) § 49 para. 5, § 49b paragraph. 2, § 51 paragraph. 2 point. h)
§ 52 paragraph. 6, § 53 par. 1, 8, 12 and 13, § 54 para. 1, § 55 paragraph. 7-9, §
56 Para. 1 point. a) § 56 par. 3 and 7, § 57 par. 2, § 58 para. 8, § 59 paragraph
. 1, § 59a. 3, § 60 par. 2, 4, 5 and 9, § 61 paragraph. 2 point. a) a
b), paragraphs 1 and 6, § 61 paragraph. 2 point. c) § 61 paragraph. 4 point. e) of § 63 para.
1 and 6, § 64 point. j) and v), § 66 para. 4, § 69 para. 2, § 70 para. 1, §
71 paragraph. 2 and 6, § 72 para. 1, § 73 para. 9 point. b) § 74 para. 1 and 5,
§ 75 para. 2, § 76 par. 2, § 77 par. 1 point. e), g), h) and i), § 77 paragraph
. 3 and 5 point. a) and b), § 79 para. 1 point. c) § 79 para. 2, 8 point.
) And c), § 79 para. 10, § 82 para. 1, § 82 par. 3 point. f) § 82 para.
4, § 83 paragraph. 2, 3, 5 and 7, § 84 par. 3, § 85 para. 1, § 86 par. 1
§ 91 para. 2 point. f) § 93j paragraph. 1, § 95 para. 2 point. b) and § 112.
2, para. 4 point. c) and paragraph. 7th

(3) The Ministry of Health, after prior consultation with the Ministry
Agriculture, the Ministry of Defense, Ministry of Interior and Ministry of Justice
issue a decree to implement § 80.

(4) The Ministry of Agriculture issues a decree to implement § 9. 3
11 and 13, § 48 par. 2, 3 and 6 and § 78 para. 3 and 4.

§ 115
Repealing provisions


Repealed:

First Law no. 79/1997 Coll., On pharmaceuticals and amending and supplementing some related laws
.

Second Act no. 129/2003 Coll., Amending Act no. 79/1997 Coll., On
pharmaceuticals and amending and supplementing some related laws.

Third Decree no. 343/2003 Coll., On the list of plants
used for pharmaceutical and therapeutic purposes.
PART TWO


Amendment to Act no. 149/2000 Coll., Amending Act no. 79/1997 Coll., On
pharmaceuticals and amending and supplementing some related laws

§ 116

In Act no. 149/2000 Coll., Amending Act no. 79/1997 Coll., On
pharmaceuticals and amending and supplementing some related Acts, Act No.
. 20/1966 Coll., Public health care, as amended, and
Act no. 455/1991 Coll., On Trades (Trade Act)
amended, was part of the first deleted.
PART THREE


Amendment to Act no. 258/2000 Coll., On public health protection

§ 117

Part Seven of Act no. 258/2000 Coll., On protection of public health and amending certain related laws
, is repealed.
PART FOUR


Amendment to Act no. 102/2001 Coll., On general product safety and amending
certain acts (GPSD)

§ 118

Part Six of Act no. 102/2001 Coll., On general product safety and
amending certain acts (GPSD), with
repealed.
PART FIVE


Amendment to Act no. 138/2002 Coll., Amending Act no. 40/1995 Coll., On
regulation of advertising and amending and supplementing Law no. 468/1991 Coll., On radio
and television broadcasting

§ 119

Part II of the Act no. 138/2002 Coll., Amending Act no. 40/1995 Coll.
On regulation of advertising and amending and supplementing Law no. 468/1991 Coll., On operating
radio and television broadcasting, as amended
and Act no. 79/1997 Coll., on pharmaceuticals and amending and supplementing
some related laws, as amended, is hereby repealed
.
PART SIX


Amendment to Act no. 309/2002 Coll., On amendment to laws related to adoption
law on service of state employees in administrative offices and
remuneration of these employees and other employees in administrative offices
(Service Act)

§ 120


Part seventeenth Act no. 309/2002 Coll., On amendment to laws related to adoption
Law on Civil servants in administrative offices and
remuneration of these employees and other employees in administrative offices
(Service Act ), is repealed.
PART SEVEN


Amendment to Act no. 320/2002 Coll., Amending and repealing certain Acts
in connection with the termination of district offices

§ 121

Part of the eighty-third Act no. 320/2002 Coll., Amending and repealing
certain laws in connection with the termination of district authorities
repealed.
PART EIGHT


Amendment to Act no. 274/2003 Coll., Amending certain acts in the field of public health protection


§ 122

Part Six of Act no. 274/2003 Coll., Amending certain laws
field of public health, is repealed.
PART NINE


Amendment to Act no. 228/2005 Coll., On control of trade in products whose
possession in the Czech Republic for security reasons, and amending certain laws


§ 123

Part IV of the Act no. 228/2005 Coll., On control of trade in products whose possession
in the Czech Republic for security reasons, and
amending some laws are repealed.
PART TEN


Amendment to Act no. 74/2006 Coll., Amending Act no. 167/1998 Coll., On
addictive substances and amending certain other laws, as
amended, Act no. 258 / 2000 Sb., on public health protection
and amending certain related laws, as amended
and Act no. 79/1997 Coll., on pharmaceuticals and amending and supplementing
some related laws, as amended amended

§ 124

Part III of the Act no. 74/2006 Coll., Amending Act no. 167/1998 Coll.
On addictive substances and amending certain other laws, as
amended, Act no. 258 / 2000 Coll., on public health protection
and amending certain related laws, as amended
and Act no. 79/1997 Coll., on pharmaceuticals and amending and supplementing
certain related acts, as amended, is hereby repealed
.
PART ELEVEN


Amendment to Act no. 527/1990 Coll., On inventions, industrial designs and rationalization proposals


§ 125

In § 18 of Act no. 527/1990 Coll., On inventions, industrial designs and
rationalization proposals, as amended by Act no. 116/2000 Coll. and Act no.
207/2000 Coll., letter e) including footnote no. 3 reads:

"E) in acts done with the subject invention for experimental purposes
including experiments and tests required under a special legal regulation
^ 3) before putting the drug on the market.

3a) Act No. 378/2007 Coll., on pharmaceuticals and amending some
related acts (Pharmaceuticals Act). ".

Existing footnote no. 3 is referred to as a footnote
no. 3b, including references to a footnote.
PART TWELVE



EFFICIENCY
§ 126

This Act shall take effect on the date of its publication.
Vlcek vr

Klaus vr



Topolánek mp Selected provisions of amendments


Art. II Act no. 70/2013 Coll.

Transitional and Final Provisions

First MAH medicinal product (hereinafter referred
"MAH"), which was issued prior to the date
commencement of this Act, from July 21, 2015, or the date
of legal force decision on renewal, if such extension
occurred before that date, shall maintain and make available on request
pharmacovigilance system master file according to § 91 paragraph
. 2 point. a) Act no. 378/2007 Coll., as amended, effective from the date of
entry into force of this Act.

Second The MAH is required to submit information on
suspected adverse reactions electronically to the database pursuant to § 93a paragraph
. 2 of Act no. 378/2007 Coll., As amended, effective from the date of entry into force of this Act
within 6 months after the European Agency for Medicines
ensure and notify the functionality of the database.

Third Obligation to operate a risk management system for each medicinal product
according to § 91 para. 2 point. c) Act no. 378/2007 Coll., as amended, effective
effective date of this Act shall not apply to holders

Holder issued before July 21, 2012.

Fourth Procedure pursuant to § 93j and 93k of Act no. 378/2007 Coll., As amended, effective
effective date of this Act shall not apply to post-authorization safety studies
commenced before the effective date of this Act.

Fifth In the implementation of non-interventional post-authorization safety studies and post-marketing studies
non-intervention in human medicine
commenced before the effective date of this Act shall be governed by
Act no. 378/2007 Coll., As amended effective on the effective date of this
Act.

6th Proceedings initiated before the effective date of this Act and to this day
will be finished and the rights and obligations related
are judged according to the law no. 378/2007 Coll., As amended effective on the effective date
this Act.

7th For medicinal products for which the validity of a marketing
finished within 9 months of the effective date of this Act may be
submit an application for renewal within the period specified in § 34 paragraph
. 1 of Act no. 378/2007 Coll., As amended effective date
force of this Act.

8th Certificates of proficiency vendor of selected medicinal products
acquired before the effective date of this Act entitle
retailer dedicated to selling medicinal products for human and veterinary
selected medicinal products even after the effective date of this Act
.

9th Persons mentioned in § 69a paragraph. 1 of Act no. 378/2007 Coll., As amended
effective from the date of entry into force of this Act, which launched its
activity prior to the effective date of this Act, submit to the State Institute
Drug control notification pursuant to § 69a paragraph. 1 and 2 of Law no.
378/2007 Coll., as amended, effective from the date of entry into force of this Act
within 2 months from the effective date of this Act.

10th Persons performing brokering medicinal products
which commenced their activity before the effective date of this Act,
at the State Institute for Drug Control register under § 77a paragraph.
1-3 of the Act no. 378/2007 Coll ., as amended, effective from the date of entry into force of this Act
, within 2 months from the date of entry into force of this Act
.

11th The effective date of this Act expires
obligation to submit periodic safety update reports stored
holders of marketing authorizations for medicinal products authorized pursuant to § 27 para. 1 or 7
Act no. 378/2007 Coll., As amended, effective from the date of
entry into force of this Act, homeopathic remedies pursuant to § 28a of Act no. 378/2007
Coll., as amended, effective from the date of entry into force of this Act, or
traditional herbal medicinal products pursuant to § 30 of Law no. 378 / 2007
Coll., as amended, effective from the date of entry into force of this Act, the
holders or their changes or decisions
renewal of these products issued before the entry into force of this Act
.

Art. II Act no. 80/2015 Coll.


Transitional provisions
State Institute for Drug Control converts from funds account maintained by
§ 112. 5 of Act no. 378/2007 Coll., As amended, effective from the date of
entry into force of this Act, the revenue account of the state budget | || Czech Republic, established the Ministry of health, in 2015
amount of EUR 1.7 billion CZK.

1) Directive of the European Parliament and Council Directive 2001/83 / EC of 6 November
2001 on the Community code relating to medicinal products for human
amended by European Parliament and Council Directive 2002/98 / EC, Directive
2003/63 / EC of the European Parliament and Council Directive 2004/24 / EC
Directive of the European Parliament and Council Directive 2004/27 / EC of the European
Parliament and Council Regulation (EC) no. 1901 / 2006 of the European Parliament and
Council (EC) no. 2006/2004 of 27 October 2004 of the European
Parliament and Council Regulation (EC) no. 1394/2007, the European Parliament and the Council
2008/29 / EC of the European Parliament and Council Directive 2009/53 / EC
Commission Directive 2009/120 / EC of the European Parliament and of the Council
2010/84 / EU of the European Parliament and of the Council 2011/62 / EU.

Directive of the European Parliament and Council Directive 2001/82 / EC of 6 November
2001 on the Community code relating to veterinary medicinal products
, as amended by Directive 2004/28 / EC.


Directive of the European Parliament and Council Directive 2001/20 / EC of 4 April 2001
regulations and administrative provisions of the Member States relating to
implementation of good clinical practice in the conduct of clinical trials on medicinal products for human
, as amended by the European Parliament and
Council Regulation (EC) no. 1901/2006.

Commission Directive 2005/28 / EC of 9 April 2005 laying down
principles and detailed guidelines for good clinical practice as regards
evaluated for human medicines and also the requirements for authorization of the manufacturing or
importation of such products.

Commission Directive 2003/94 / EC of 8 October 2003 laying down
principles and guidelines of good manufacturing practice in respect of human medicinal products and
rated CHMP.

Directive of the European Parliament and Council Directive 2002/98 / EC of 27 January 2003
laying down standards of quality and safety for the collection, testing,
processing, storage and distribution of human blood and blood components | || amending Directive 2001/83 / EC.

Commission Directive 2004/33 / EC of 22 March 2004 implementing
Directive of the European Parliament and Council Directive 2002/98 / EC as regards certain
technical requirements for blood and blood components.

Commission Directive 2005/61 / EC of 30 September 2005 implementing
Directive of the European Parliament and Council Directive 2002/98 / EC as regards requirements
traceability and notification of serious adverse reactions and events .
Commission Directive 2005/62 / EC of 30 September 2005 implementing
Directive of the European Parliament and Council Directive 2002/98 / EC as regards
standards and specifications relating to a quality system for
blood establishments.

Commission Directive 91/412 / EEC of 23 July 1991 laying down
principles and guidelines of good manufacturing practice for veterinary medicinal products
.

Council Directive 90/167 / EEC of 26 March 1990 laying down
conditions for preparing, marketing and use of medicated feeds in the Community
.

Directive of the European Parliament and Council Directive 2004/9 / EC of 11 February 2004
inspection and verification of good laboratory practice (GLP).

Directive of the European Parliament and Council Directive 2004/10 / EC of 11 February 2004
on the harmonization of laws, regulations and administrative provisions relating to the principles of good
Laboratory Practice using these principles for tests performed with chemicals
substances.

Council Directive 2001/18 / EC of 12 March 2001 on the deliberate release
genetically modified organisms into the environment, which
repealing Council Directive 90/220 / EEC.

Council Directive 96/23 / EC of 29 April 1996 on measures to
monitoring of certain substances and residues in live animals and animal products
.

Council Directive 2003/85 / EC of 29 September 2003 laying down
Community measures for the control of foot-and-mouth disease repealing
Directive 85/511 / EEC and Decision 89/531 / EEC and 91 / 665 / EEC and amending
Directive 92/46 / EEC.

2) Regulation of the European Parliament and Council Regulation (EC) no. 726/2004 of 31
March 2004 laying down Community procedures for the authorization and supervision
human and veterinary medicinal products and laying | || based European Medicines Agency, as amended by European
Parliament and Council Regulation (EC) no. 1901/2006.

Regulation of the European Parliament and Council Regulation (EC) no. 1901/2006 of 12
December 2006 on medicinal products for pediatric use and amending
Regulation (EC) no. 1768/92, Directive 2001/20 / EC, Directive 2001/83 / EC and
Regulation (EC) no. 726/2004.

Council Regulation (EC) no. 141/2000 of 16 December 1999 on medicinal
products for rare diseases.

Council Regulation (EEC) No 2377/90. Of 26 June 1990 laying
down Community procedures for the establishment of maximum residue limits in foodstuffs of animal origin
for veterinary medicinal products, as amended
amended.

Council Regulation (EEC) no. 339/93 of 8 February 1993 on checks for conformity with
regulations on product safety in case of products imported from third countries
.

Regulation of the European Parliament and Council Regulation (EC) no. 1831/2003 of 22 September
2003 on additives for use in animal nutrition.

Commission Regulation (EC) no. 1234/2008 of 24 November 2008
assessing changes in human and veterinary medicinal products
.

3) Regulation of the European Parliament and Council Regulation (EC) no. 1831/2003.


4) Convention for the elaboration of the European Pharmacopoeia and the Protocol to the Convention for
elaboration of the European Pharmacopoeia, published under no. 255/1998 Coll.

5) European Parliament and Council Regulation (EC) no. 470/2009 of 6
May 2009 laying down Community procedures for determining
residue limits of pharmacologically active substances in foodstuffs of animal origin
repealing Council Regulation (EEC) No 2377/90., and laying
amending Directive of the European Parliament and Council Directive 2001/82 / EC and Regulation
European Parliament and Council Regulation (EC) no. 726/2004 (Text
with EEA relevance).

6) § 58 of Act no. 235/2004 Coll., On Value Added Tax, as amended
.

§ 12 of Act no. 634/1992 Coll., On consumer protection, as amended
.

§ 13 of Act no. 526/1990 Coll., On prices, as amended.

7) Act no. 48/1997 Coll., On public health insurance and amending and supplementing certain
related laws, as amended.

8) Act no. 166/1999 Coll., On veterinary care and amending certain
related laws (Veterinary Act), as amended.

Act no. 246/1992 Coll., On protection of animals against cruelty, as amended
.

9) Act no. 372/2011 Coll., On health services and conditions of their
provision (Health Services Act).

10) § 58 of Act no. 166/1999 Coll., As amended by Act no. 131/2003 Coll.

11) Act no. 78/2004 Coll., On the use of genetically modified
organisms and genetic products as amended by Act no. 346/2005 Coll.

12) Act no. 59/1998 Coll., On liability for damage caused by
product, as amended by Act no. 209/2000 Coll.

13) Act no. 18/1997 Coll., On peaceful use of nuclear energy and
ionizing radiation (Atomic Act) and amending and supplementing certain
Acts, as amended.

14) European Parliament and Council Directive 2001/82 / EC as amended by Directive
2004/28 / EC.

15) For example, Council Directive 2003/85 / EC Council Directive 92/66 / EEC of
14th July 1992 introducing Community measures for the control
Newcastle disease Council Directive 2002/60 / EC of 27 June 2002
laying down specific provisions for the control of African swine fever
and amending Directive 92/119 / EEC as regards Teschen disease
and African swine fever.

16) Commission Decision 93/623 / EEC of 20 October 1993
identification document (passport) accompanying registered
equines.

Commission Decision 2000/68 / EC of 22 December 1999 amending
Commission Decision 93/623 / EEC and establishing the identification of breeding and equine
utility.

17) § 19 par. 3 of Law no. 166/1999 Coll., As amended by Act no. 131/2003 Coll
.

18) Act no. 166/1999 Coll., As amended.

19) § 58-60 of the Act no. 166/1999 Coll., As amended by Act no. 131/2003 Coll.

20) § 3 of the Act no. 166/1999 Coll., As amended by Act no. 131/2003 Coll.

21) Article. 43 et seq. Treaty establishing the European Community.

22) Act no. 455/1991 Coll., On Trades (Trade
Act), as amended.

Decree no. 140/2000 Coll., Establishing a list of trades
free, as amended.

23) For example, Council Regulation (EC) no. 141/2000 of the European
Parliament and Council Regulation (EC) no. 726/2004 of the European Parliament and
Council Regulation (EC) no. 1901/2006 .

24) European Parliament and Council Regulation (EC) no. 726/2004.

25a) § 4c Act no. 252/1997 Coll., On agriculture, as amended by Act no. 291/2009 Coll
.

25b) Article. 48 Commission Regulation (EC) no. 796/2004 of 21 April 2004
laying down detailed rules for compliance, modulation and
integrated administration and control system
set out in Council Regulation (EC) No . 1782/2003 establishing common rules
for direct support schemes under the common agricultural policy and establishing
establishing certain support schemes for farmers, as amended.

26) Act no. 123/2000 Coll., On medical devices and change
some related laws, as amended.

Decree no. 336/2004 Coll., Laying down technical requirements
medical devices and amending Government Decree no. 251/2003

Coll., Amending some Government Orders issued pursuant to Act no.
22/1997 Coll., On technical requirements for products and amending and supplementing
certain laws, as amended.

27) Council Regulation (EEC) no. 339/93.

28) § 52 of the Act no. 166/1999 Coll., As amended.

29) Act no. 95/2004 Coll., On conditions for the acquisition and recognition of professional
and specialized competencies to perform medical
professions of doctor, dentist and pharmacist, as amended by Act no. 125
/ 2005 Sb.

Law no. 96/2004 Coll., On conditions for obtaining and recognition of qualifications for
pursuing paramedical professions and for activities
providing health care and amending certain
related laws (Act on paramedical professions)
amended by Act no. 125/2005 Coll.

30) Act no. 18/2004 Coll., On the recognition of professional qualifications and other
of nationals of Member States of the European Union and
amending some laws (Act on recognition of professional qualifications), as amended
amended.

30a) Act no. 269/1994 Coll., On Criminal Records, as amended
regulations.

31) Act no. 95/2004 Coll., As amended by Act no. 125/2005 Coll.

32) Act no. 111/1998 Coll., On universities and on amendments and supplements
other acts (the Universities Act), as amended
regulations.

33) Act no. 96/2004 Coll., As amended by Act no. 125/2005 Coll.

34) Act no. 185/2001 Coll., On waste and amending certain other
Acts, as amended.

Decree no. 383/2001 Coll., On details of waste management, as amended
Decree no. 41/2005 Coll.

35) Act no. 246/1992 Coll., As amended.

Decree no. 207/2004 Coll., On protection, breeding and use of experimental animals.

36) Act no. 101/2000 Coll., On protection of personal data and amending certain laws
, as amended.

37) Article. 4, paragraph. 16 of Council Regulation (EC) no. 2913/92 of 12 October
1992 establishing the Community Customs Code, as amended
regulations.

37a) § 32 par. 2 of Act no. 373/2011 Coll., On specific health
services.

38) Art. 4, paragraph. 18 of Council Regulation (EC) no. 2913/92, as amended
regulations.

39) Article 5 of Council Regulation (EC) no. 2913/92, as amended
regulations.

39a) Act no. 296/2008 Coll., On ensuring quality and safety of human
tissues and cells intended for human use and amending related laws
(Act on human tissues and cells).

40) Act no. 167/1998 Coll., On addictive substances and amending certain
other laws, as amended.

41) Act no. 634/2004 Coll., On administrative fees, as amended
regulations.

42) Council Regulation (EC) no. 141/2000.

43) Act no. 527/1990 Coll., On inventions and rationalization proposals,
amended.

44) Article 17 of the European Parliament and Council Directive 2001/82 / EC, as amended
Directive 2004/28 / EC.

45) Article 16h of the European Parliament and Council Directive 2001/83 / EC, as amended
Directive 2004/24 / EC.

46) § 51a of Act no. 166/1999 Coll., As amended by Act no. 131/2003 Coll.

§ 17 of Decree no. 291/2003 Coll., As amended by Decree no. 232/2005 Coll.

47) For example, an agreement on mutual recognition in relation to conformity assessment
certification and labeling between the European Community and Australia (OJ.
P. L 229, 17. 8. 1998, p. 3) Agreement on mutual recognition in relation to conformity assessment
between the European Community and New Zealand (OJ.
p. L 229, 17. 8. 1998, p. 62), the agreement on mutual recognition between the European Community and
Canada (OJ. OJ. L 280, 16. 10. 1998, p.
3), the agreement on mutual recognition between the European Community and Japan
(OJ. OJ. L 284, 29. 10. 2001, p . 3)
Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment
(OJ. OJ. L 114, 30. 4. 2002, p. 369).

48) For example, § 2. h) Decree no. 291/2003 Coll.

49) For example, Council Decision no. 1999/879 / EEC of 17 December 1999
on the marketing and administration of bovine somatotropin
and repealing Decision 90/218 / EEC.

50) § 51a of Act no. 166/1999 Coll., As amended by Act no. 131/2003 Coll.


§ 17 and 18 of Decree no. 291/2003 Coll., As amended by Decree no. 232/2005 Coll.

51) Act no. 40/1995 Coll., On regulation of advertising and amending and supplementing
Act no. 468/1991 Coll., On radio and television broadcasts
, as amended.

52) Act no. 227/2000 Coll., On electronic signatures and amending certain
other laws (Electronic Signature Act), as amended
regulations.

53) Articles 32 to 34 of Directive of the European Parliament and Council Directive 2001/83 / EC
amended by Directive 2004/27 / EC.

Articles 36 to 38 of Directive of the European Parliament and Council Directive 2001/82 / EC, as amended
Directive 2004/28 / EC.

54) Directive 87/22 / EEC of 22 December 1986 on the approximation
national measures relating to the placing of medicines
manufactured with sophisticated technology, particularly those that are made
biotechnology market.

55) For example, the Commercial Code, Act no. 527/1990 Coll., On Inventions and
rationalization proposals, as amended, Act no. 441/2003
Coll., On Trademarks and on Amendments to Act no. 6/2002 Coll., on courts,
judges, lay judges and state administration of courts and amending certain other
acts (courts and judges), as amended,
(trademark law ), as amended.

56) Act no. 185/2001 Coll., As amended.

57) Article 83 of the European Parliament and Council Regulation (EC) no. 726/2004.

58) Art. 83 paragraph. 1 and 2 of European Parliament and Council Regulation (EC) no. 726/2004
.

59) Article 3 of Directive 2005/28 / EC.

60) For example Act no. 101/2000 Coll., As amended,
Civil Code and the Criminal Code.

61) § 34 of the Act no. 94/1963 Coll., On family, as amended.

62) For example Act no. 123/2000 Coll., As amended.

63) Act no. 20/1966 Coll., As amended.

Decree no. 385/2006 Coll., On medical documentation.

64) § 23 of Act no. 246/1992 Coll., As amended by Act no. 77/2004 Coll.

65) Scheme of the World Health Organization for Quality Certification
pharmaceutical products moving in international trade (
WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
) in the current version published by the World || | Health Organisation.

66) § 44 of Act no. 111/1998 Coll., As amended by Act no. 147/2001 Coll.

67) § 8 par. 1 of Act no. 141/1961 Coll., On criminal court proceedings
(Criminal Procedure Code), as amended by Act no. 178/1990 Coll. and Act no. 558/1991 Coll.

68) Act no. 91/1996 Coll., On feedingstuffs, as amended.

69) For example, Act no. 120/2002 Coll., On conditions for placing biocidal
products and active substances on the market and amending some related laws
, as amended, Act no. 167/1998 Coll. , as
amended, Act no. 326/2004 Coll., on phytosanitary care and
amending certain related laws, as amended,
Act no. 166/1999 Coll., as amended regulations, the Act no. 91/1996
Coll., as amended.

70) Act no. 258/2000 Coll., As amended.

71) § 10 paragraph. 2 point. b) and § 11 para. 1 of Act no. 160/1992 Coll., as amended
Act no. 121/2004 Coll.

72) For example, the Labour Code, Act no. 78/2004 Coll., As amended by Act no. 346/2005 Coll
., Act no. 166/1999 Coll., As amended.

73) § 88a of Act no. 258/2000 Coll., As amended by Act no. 320/2002 Coll.

74) Act no. 455/1991 Coll., As amended.

75) Decree no. 383/2001 Coll., As amended by Decree no. 41/2005 Coll.

Decree no. 381/2001 Coll., Establishing the Waste Catalogue, as amended
Decree no. 503/2004 Coll.

76) Act no. 381/1991 Coll., On the Chamber of veterinarians, as amended
.

77) For example, Act no. 231/2001 Coll., On radio and television broadcasting
and amending other laws, as amended
regulations.

78) Act no. 552/1991 Coll., On state control, as amended
regulations.

79) Act no. 102/2001 Coll., On general product safety and amending
certain acts (GPSD), as amended
.

80) § 137 of the Act no. 500/2004 Coll., Administrative Procedure.


81) § 143 of the Act no. 500/2004 Coll., Administrative Procedure.

82) European Parliament and Council Regulation (EC) no. 1901/2006 on medicinal
products for pediatric use and amending Regulation (EEC) No.
1768/92, Directive no. 2001/20 / EC Directive no. 2001/83 / EC and Regulation (EC) No.
. 726/2004.

83) § 2 para. 2 of the Commercial Code.

84) For example, the European Parliament and Council Regulation (EC) no. 726/2004.

85) § 6 para. 1 of Act no. 218/2000 Coll., On budgetary rules and
amending certain related laws, as amended.

86) Commission Directive 2009/120 / EC of 14 September 2009 amending
Directive of the European Parliament and Council Directive 2001/83 / EC on the Community code
relating to medicinal products for human in terms of Medicines
advanced therapy.

87) European Parliament and Council Regulation (EC) no. 1394/2007 of 13 November 2007
on medicines for advanced therapy
and amending Directive 2001/83 / EC and Regulation (EC) No . 726/2004.

88) For example, § 25 of Act no. 258/2000 Coll., On protection of public health and
amending certain related laws, as amended, § 2
Act no. 110/1997 Coll. on foodstuffs and tobacco products and
amending and supplementing some related laws, as amended
regulations, § 2 of the Act no. 123/2000 Coll., as amended.

89) Article. 26 Regulation of the European Parliament and Council Regulation (EC) no. 726/2004.

90) Commission Regulation (EC) no. 1234/2008, as amended by Commission Regulation (EU) no. 712/2012
.

91) Art. 56 Para. 1 point. a) Regulation of the European Parliament and Council Regulation (EC) No.
. 726/2004.

92) Article. 28 Regulation of the European Parliament and Council Regulation no. 1394/2007 dated
13th November 2007 on medicinal products for advanced therapy
and amending Directive 2001/83 / EC and Regulation (EC) no. 726/2004.

Art. 3 point 7 Directive of the European Parliament and Council Directive no. 2001/83 / EC, as amended
.

93) For example, the Civil Code, Act no. 480/2004 Coll., On certain
information society services and amending certain acts (
certain information society services), as amended
regulations.

94) Art. 108 and Art. 108a of the European Parliament and of the Council
2001/83 / EC, as amended by European Parliament and Council Directive 2010/84 / EU.

95) Art. 24 Regulation of the European Parliament and Council Regulation (EC) no. 726/2004.

96) Art. 27 Regulation of the European Parliament and Council Regulation (EC) no. 726/2004.

97) Art. 25 Regulation of the European Parliament and Council Regulation (EC) no. 726/2004.

98) Art. 25a of the European Parliament and Council Regulation (EC) no. 726/2004.

99) For example, Act no. 48/1997 Coll., As amended, Act No.
. 123/2000 Coll., As amended, Act no. 40/1995 Coll.,
Amended, Act no. 167/1998 Coll., As amended
regulations, Law no. 265 / 1991 Coll., on the competence of the Czech Republic in
prices, as amended, Act no. 526/1990 Coll., as amended
.