Amendment To The Act On Pharmaceuticals

Original Language Title: změna zákona o léčivech

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70/2013 Coll.


LAW
Of 19 February 2013

Amending Act no. 378/2007 Coll., On pharmaceuticals and amending some
Related Acts (Pharmaceuticals Act), as amended

Change: 255/2014 Coll.

Parliament has passed this Act of the Czech Republic:

Art. I

Amendment to the Act on Pharmaceuticals

Act no. 378/2007 Coll., On pharmaceuticals and amending some related
Acts (Pharmaceuticals Act), as amended by Act no. 124/2008 Coll., Act no. 296/2008 Coll
. Act no. 141/2009 Coll., Act no. 281/2009 Coll., Act no. 291/2009 Coll
., Act no. 75/2011 Coll., Act no. 375/2011 Coll. and Act no.
50/2013 Coll., is amended as follows:

First In footnote no. 1, the first sentence is replaced "
Directive of the European Parliament and Council Directive 2001/83 / EC of 6 November 2001 on
Community code relating to medicinal products, as amended by Directive
European Parliament and Council Directive 2002/98 / EC Commission Directive
2003/63 / EC of the European Parliament and Council Directive 2004/24 / EC, Directive
European Parliament and Council Directive 2004/27 / EC of the European Parliament | || and Council Regulation (EC) no. 1901/2006, the European Parliament and the Council (EC) no.
2006/2004 of 27 October 2004 of the European Parliament and of the Council
(EC) no. 1394 / 2007 of the European Parliament and Council Directive 2008/29 / EC
Directive of the European Parliament and Council Directive 2009/53 / EC, Commission Directive
2009/120 / EC of the European Parliament and Council Directive 2010/84 / EU
Directive of the European Parliament and Council Directive 2011/62 / EU. ".

Second At the end of footnote no. 2 on a separate line complements
phrase "Commission Regulation (EC) no. 1234/2008 of 24 November 2008
assessing changes in human and veterinary medicinal products
. ".

Third In § 2 para. 2 point. n) the word "transfusion" is deleted.

Fourth In § 2 paragraph 4 reads:

"(4) A substance 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 materials. ".

Fifth In § 3 para. 2 the words "EU regulation ^ 5)" is replaced
"EU regulation laying down the procedures for determining the levels
residues of pharmacologically active substances in foodstuffs of animal origin
^ 5)."

Footnote. 5 reads:

"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
). ".

6th In § 3 para. 4 of the introductory part of the first sentence is replaced by the sentences
"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. ".

7th In § 3 para. 7, after the word "security" the words "u
veterinary medicinal product."

8th In § 3, paragraphs 11 and 12 deleted.

9th Under § 3, the following new § 3a is inserted:

"§ 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. ".

10th In § 5 para. 5 and the first sentence of § 6 para. 1 point. b) the words
"medicines" are replaced by "drugs".

11th In § 5, the following paragraphs 13 to 15 are added:

"(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 their essence 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. ".

12th § 6 para. 1 point. a) the words "manufacturer of APIs and excipients manufacturers
" is replaced by "a manufacturer of active substances".

13th § 6 para. 2, 'or production aids according to §
70, "are deleted.

14th In § 8 par. 3 of the introductory part of the word "if" is replaced
words "only in a situation where at the same time."

15th In § 8 par. 3 letter b) reads:

"B) it is a medicine that is

First already registered in another state or

Second advanced therapy product whose manufacturer is the holder
for the manufacture of the dosage form to the extent corresponding permit to manufacture
IMPs issued by the State Institute for Drug Control
".

16th In § 8. 5 sixth sentence after the word "prescribing" the words
"or use" at the end of paragraph 5 the following sentence "
medicinal product pursuant to paragraph 3. b) paragraph 2 shall be marked at least
manner specified in § 57 par. 2. '.

17th In § 8 the following paragraph 8 is added:

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

18th In § 9 par. 2 point. a) the words "State Veterinary Administration"
replaced by "The Central Veterinary Administration of the State Veterinary Administration
(hereinafter referred to as" the Central Veterinary Authority '). "

19th In § 9. 14, the term "regional veterinary administration or
Municipal Veterinary Administration in Prague" is replaced by "regional veterinary administration
State Veterinary Administration or Municipal Veterinary Administration in Prague
State Veterinary Administration."

20th In § 10 paragraph. 1 point e) deleted.

Existing letters f) to j) shall be designated as letters e) to i).

21st In § 10 paragraph. 2 point. b) the title of § 15, § 15 of the first part
provision, § 16 para. 1, first sentence, the title of § 46, § 46 para. 1
introductory part of the provision, § 46 para. 1 point. a) Section 2, § 46 para. 2, 3 and 6
§ 47 paragraph. 1 and § 79 para. 8, the word "State" is replaced by
"Central".

22nd In § 11 point. e) the words "plasma for the production of blood derivatives"
replaced by "raw materials for further production."

23rd In § 11 point. p) the words "blood products" the words
"or raw material for further production."

24th In § 11 at the end of the letter P) replaces the comma and full stop point q)
was deleted.

25th In the heading of § 12, § 12 and § 109 para. 4 point. e)
after the word "justice" the comma is replaced by the word "and" and "and
Ministry of Finance" shall be deleted.

26th In § 13 par. 2 letter g) reads:

"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 this Act. ".

27th In § 13 at the end of paragraph 2 is replaced by a comma and
letters j) to m) are added:

"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. ".

28th In § 13 at the end of paragraph 3 is replaced by a comma and letters
o) ap), added:

"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.".

29th In § 18, § 31 par. 7 and § 55 paragraph. 2, "which are the source of ionizing radiation
^ 13)" are deleted.

30th In § 23 at the end of paragraph 1 is replaced by a comma and a letter
e), added:

"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, the medicinal substance or auxiliary
the substance of 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. ".

31st In § 23 para. 2 of the introductory part of the provision, the words "not indicate"
words "on the market".

32nd In § 23 para. 4 at the end of the text of letter a) the words "and that
for human medicines or veterinary medicines;
Case of human medicinal products, is not required to obtain a certificate of professional competence
vendor of selected medicinal products in
pharmacists and pharmaceutical assistants ^ 29), in the case of veterinary medicinal products
may certificate of proficiency vendor of selected medicinal products
substitute proof of graduation from an accredited medical
master's degree program in pharmacy pursuant to the Act on
requirements for acquisition and recognition of professional and specialized qualifications,
or an accredited master's study program of veterinary | || medicine or an accredited master's degree program
veterinary hygiene and ecology. "

33rd In § 23 para. 4 point. f) the words "and proof of purchase, storage and sale of reserved
medicines kept for at least 5 years'
deleted.

34th In § 23 at the end of paragraph 4 is replaced by a comma and
letter g), added:

"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 dosage forms, the type and content of container
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. ".

35th In § 24 para. 4 of the first sentence the words "plasma for the production of blood derivatives
" is replaced by "raw material for further production."

36th In § 24 para. 5 point. a) the words "plasma for the production of blood derivatives
" is replaced by "raw materials for further production."

37th In § 24 para. 5 point. d) the words "haemotherapy or"
replace the word "haemotherapy".

38th In § 24 para. 5 letter e) including footnote no. 37a reads:

"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
authorization 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

37a) § 32 par. 2 of Act no. 373/2011 Coll., On specific health
services. ".

39th In § 24 at the end of paragraph 5 the following point f) is added:

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

40th In § 24, after paragraph 6 the following paragraph 7 is added:

"(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 him the previous period.".

Former paragraphs 7-9 become paragraphs 8 to 10

41st In § 24 para. 8, the first sentence is replaced "operator, which

Been granted consent pursuant to paragraph 4, notify the Ministry of Health
about the actual imports from third countries or export to third countries
or distribution within the European Union, within 10 days after the expiry
granted permission . '.

42nd § 24a including the heading and footnote no. 88 reads:

"§ 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.

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. ".

43rd In § 25, at the end of paragraph 2 is replaced by a comma and
letter i), which reads:

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

44th In § 25 paragraph 3 reads:

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

45th In § 26 par. 5, the letter h) the following point i) is added:

"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. "

Existing letters i) to s) are renumbered j) to t).

46th In § 26 par. 5 letter a) reads:

"K) 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 ".

47th In § 26 par. 5, the letter k) the following new paragraph l), which reads:

"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 ".

Existing letters l) to t) are renumbered m) to u).

48th In § 26 par. 5 letter p) reads:

"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. "

49th In § 26 par. 5 at the end of letter t) replaces the comma and full stop
U) is repealed.

50th In § 26 par. 6 of the first and second sentence, § 27 para. 1, 7, 8 and 10, § 28 paragraph
. 3, § 30. 3 point. a) and § 31 para. 5 point. h) the words
"point. i) "is replaced by" point. j) ".

51st In § 26 par. 7, third sentence, the words "point. n) "is replaced
" point. p) ".

52nd The heading of § 28 'simplified registration procedure "is deleted and
title under § 28 reads:" The simplified registration procedure for homeopathic products for human use
".

53rd In § 28 par. 3, second sentence, the words "point. j) k) l) "are replaced
words" point. k) to n). "

54th Under § 28 the following § 28a, including the heading reads:

"§ 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. ".

55th In § 30 paragraph. 3 point. a) the words "l), m), q) as)" is replaced
'n), o) as) ".

56th In § 30 paragraph. 7, the last sentence is deleted.

57th In § 30 the following paragraphs 9 and 10 are added:

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

'58. In § 31 para. 4, the words "point. n) "is replaced by" point. p) ".

59th In § 31 para. 5 point. a) at the end of the text of point 4, the words "
and that does not cause a false or misleading impression in assessing
title medicinal product in relation to the target group of patients and
summary of product characteristics".

60th In § 31 para. 5 letter c) reads:

"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); ".

61st In § 31 paragraph 8 reads:

"(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 medicine
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
. ".

62nd Under § 31 the following § 31a is inserted:

"§ 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 medicinal product. ".

63rd In § 32 par. 1 final part of the provision reads:

"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 the summary of product. ".

64th In § 32 par. 2, "§ 34 par. 3" is replaced by "§ 34a".

65th In § 32 paragraph 3 reads:

"(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 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. ".

66th In § 32 para. 4 point. b) the words "§ 92. 7 and" are deleted.

67th Under § 32, the following new § 32a and 32b, which including footnotes
fn. 91 added:

"§ 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.

91) Art. 56 Para. 1 point. a) Regulation of the European Parliament and Council Regulation (EC) No.
. 726/2004. ".

68th In § 33 paragraph 1, including footnote no. 89 reads:

"(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.

89) Article. 26 Regulation of the European Parliament and Council Regulation (EC) no. 726/2004. ".

69th In § 33 para. 2 first sentence, the words "packages on the market in the Czech Republic
" the words "not later than two months after his
actual placing on the market".

70th In § 33 par. 2 at the end of the first sentence of the text, the words ", it
including the reasons for such suspension or termination."

71st In § 33 par. 3 letter a) reads:

"A) to 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, comply with 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 enabling their
traceability ".

72nd In § 33 par. 3 at the end of the text of letter c) the words ";
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 ".

73rd In § 33 par. 3 point. d) the word "control" the words "
reference substances in quantities of controlled batches
and the possible need for repeated inspections".

74th In § 33 par. 3 point. g) at the end of the text of point 1, the words "
part of the information provided through the publicly accessible
professional information services and current information about whether or not
medicinal product is marketed in the Czech Republic" .

75th In § 33 par. 3 point. g) point 2, the words "in accordance with § 91 para. 2
point. a) "shall be deleted.

76th In § 33 par. 3 point. g) point 3 is deleted.

Present point 4 becomes point 3

77th In § 33 at the end of paragraph 3 is replaced by a comma and
letter i), which reads:

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

78th In § 33 after paragraph 3 new paragraphs 4 and 5 are added:

"(4) The MAH, in the case of a human medicinal product
is obliged to inform the Institute and the Member States
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
Czech Republic asked for cancellation of registration or
not applied for renewal of the authorization, together with the reasons for such action.
This announcement MAH making even if it was
measures taken in a third country and establish if on any of the grounds
mentioned in § 34 para. 4 and § 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 and § 90 par. 3. ".

Former paragraphs 4 and 5 shall be renumbered 6 and 7

79th In § 34 para. 1, second sentence, the number "6" is replaced by "9".

80th In § 34 para. 1, the third sentence is replaced by the phrase "If it is a human
medicine, provide MAH
Institute together with the request or at the latest nine months before the expiry of the registration
current comprehensive documentation covering the quality, safety and efficacy
, including the 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
of any changes introduced since the marketing authorization. ".

81st In § 34 para. 1 sentence seventh replaced by "If it is a human
medicine Institute on grounds related
pharmacovigilance, including exposure of an insufficient number of patients
medicinal product concerned may decide to re
extension of the marketing authorization for the next 5 years; in the case of a veterinary medicinal product
, the Veterinary Institute may decide that only one
extension of a marketing authorization for a further 5 years, on the basis
legitimate grounds relating to pharmacovigilance. ".

82nd In § 34 para. 1 sentence eighth and § 34 para. 6 of the first sentence and the second
words "5 or 6" is replaced by "four or five".


83rd In § 34 paragraph 3 is deleted.

The former paragraphs 4 to 9 shall be renumbered 3 to 8

84th In § 34 par. 3, the number "12" is replaced by "5".

85th In § 34 par. 4, letter a) reads:

") The medicinal product is harmful."

86th In § 34 par. 4, letter c) reads:

"C) the risk-benefit balance of a medicinal product is not favorable
or when using the veterinary medicinal product
accordance with the terms of its registration is not risk-benefit ratio
favorable".

87th In § 34 para. 4 letter j) reads:

"J) not submitted evidence of checks in accordance with § 64 point. at),".

88th In § 34 para. 4 letter k) reads:

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

89th In § 34 para. 4, at the end of letter l) is replaced by a comma and
adds the word "or".

90th In § 34 at the end of paragraph 4 the following point m), which reads:

"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). ".

91st In § 34 para. 6 second sentence, the word "information" is replaced
"no information".

92nd In § 34 para. 6 of the fifth sentence is replaced by the phrase "If no
removing the reasons that led to the suspension of registration within the set deadline
or within 3 years from the date of the decision to suspend the registration
if the deadline for their removal was determined
decides Institute or the Veterinary Institute for deregistration
medicinal product. ".

93rd In § 34 paragraph 7 reads:

"(7) The registration of a medicinal product 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. ".

94th In § 34 para. 8, the first sentence following the sentence "on how to download
medicinal product and the time required to perform this download is required
inform the Institute or the Veterinary Institute proceedings to cancel
registration and if that the registration expires when the period of its validity
no later than 15 days before the extinction. ".

95th Under § 34 the following § 34a is added:

"§ 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 on

Registration published by 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 decision to grant an exemption. " .

96th § 35 including the title and footnote no. 90 reads:

"§ 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 safety 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.

90) Commission Regulation (EC) no. 1234/2008, as amended by Commission Regulation (EU) no. 712/2012
. ".

97th In § 36 para. 4 sentence of the third and fourth sentences are replaced by 'medicinal product
corresponding data and documentation prior to the transfer

Registration, unless the decision on registration of transfer
stated otherwise, may continue to be marketed for a maximum period of 180 days from the date of registration of transfer
. Distribute, publish, in the case of reserved
medicinal products sold, and used in the provision of health care or veterinary care
such medicine can be no longer than his
usability. ".

98th In § 37 para. 1 first sentence, the word "product" the words "
, with the exception of homeopathic products registered pursuant to § 28".

99th In § 37 para. 4 first sentence, the words "homeopathic preparations"
words "registered in accordance with § 28".

100th In § 37 para. 6 the words '' homeopathy ''
replace the words '' homeopathic medicinal product '' and ''
homeopathic veterinary medicine '' is replaced by '' homeopathic veterinary medicinal product
"".

One hundred and first In § 37, paragraphs 7 and 8 are added:

"(7) The outer packaging of medicinal products or their internal packaging
if there is no outer packaging must be for Medicinal Products
under paragraph 8, with the exception of radiopharmaceuticals include security features that || | distributors and persons authorized to supply medicinal products for human
to verify the authenticity of the medicinal product, identify individual
packaging and verify whether or not the outer packaging has been tampered with.
Design and technical processing of protective elements determined by the Commission.

(8) The safety features referred to in paragraph 7 must be provided Medicinal
products sold only on prescription or on medical prescription
restrictions that are not included on the list of medicines that do not bear
guards, adopted by the Commission.
Protective elements referred to in paragraph 7 may not be provided with humane medicines that
be issued without a prescription and which are not listed
placing medicinal products that bear the safety features
adopted by the Commission. Lists of medicinal products or their
categories that must or must not bear the safety features,
determined by the Commission. '.

102nd In § 38, the first sentence is replaced "Unless medicine
intended to be delivered directly to the patient, or where there are severe problems with
availability of medicine, the Institute or Veterinary Institute
Holder permit not to appear on the labeling and package leaflet
contain certain information; the competent institution may also
wholly or partly allow the labeling and package leaflet
information was not in the Czech language. ".

103rd In § 39 paragraph 1 reads:

"(1) In 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
prescription and limitation. ".

104th In § 41 paragraph. 1, the last sentence is replaced by the sentences "
Where a 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"). " .

105th In § 41 at the end of the text of paragraph 2, the words "for registration
electronically."

106th In § 41 at the end of paragraph 4, the sentence "This is true even in the case
submission pursuant to paragraph 2.".

107th In § 41 paragraph. 7, the number "5" is replaced by "4".

108th In § 42 para. 2, the first sentence is replaced by the sentences "
Institute or the Veterinary Institute, the registrant or the holder of
registration in specific cases that relate to the interests of the European Union
refers the matter to the Committee for Human Medicines or
Committee for veterinary medicinal products to apply the referral procedure

Before any decision is reached on an application for registration
or suspension or revocation of registration or any other variation
registration, which seemed to be necessary. If the referral results from the evaluation of pharmacovigilance data
registered
human medicinal product shall refer the matter to the Pharmacovigilance Assessment Committee
risk drugs. ".

109s. In § 42 at the end of paragraph 2 the sentence "If
fulfilled any of the conditions listed in § 93i paragraph. 1 and 2, the Institute shall proceed in accordance with § 93i
.".

110th In § 42 para. 5, "the Institute or" are deleted, the words "public health
" is inserted comma and the words "and in the case of veterinary medicinal products, also for
" shall be deleted and the words "or cancel"
is inserted the word "such".

111th In § 42 para. 6 of the first sentence the words' Institute or "are deleted, the words
" public health "is inserted comma, the word" or "shall be deleted and the
second sentence, the word" constitution, or " and the words "under its jurisdiction"
deleted.

112th In § 42, paragraph 8 shall be added:

"(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 action. ".

113th In § 44 par. 2 point. c) the words "unless pursuant to § 38
specified otherwise" is replaced by "The Institute may decide that
this condition need not be met if it does not increase
risk to human health in the context with the use of a medicinal product ".

114 respectively. In § 44 para. 8, the words "paragraph. 5 or 6 "is replaced by" paragraph.
4 or 5 ".

115th In § 49 the following paragraphs 6-9 are added:

"(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. ".

116th Under § 49, the following new § 49a and 49b, which
including the title and footnote no. 92 added:

§ 49a

Request on "emocniční exception for 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
workplaces where the medicine within the hospital exceptions
given, subject to authorization Institute. 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.

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
. ".

117th In § 51 paragraph. 1, "the study, which are assessment
using medicines as usual and in accordance with the terms of their registration
" are replaced by "post-marketing studies."

118th In § 51 par. 2 letter a) reads:

"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. "

119th In § 53 par. 4 first sentence, the words "ethics committee"
inserted the words "and multicentric ethics committee" in the second sentence, the word
"assigned" is replaced by "asking about the destination" and in the last sentence
with the word "commission" the words "and multicentric ethics committee".

120th In § 56 par. 9 of the first and second sentence, the word "prohibit"
replaces the word "terminated" and in the fourth sentence, the word "ban" is replaced by
"closure".

121st Under § 59 the following § 59a, including the heading reads:

"§ 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. ".

122nd In § 62 paragraph 3 is deleted.

Former paragraph 4 becomes paragraph 3

123rd In § 63 para. 8, the words "paragraph. 4 "are replaced by" paragraph. 3 ".

124th In § 64 letter c) reads:

"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, such as carried out by contractors. "

125th In § 64 after the letter k), new letters l) to p)
added:

"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 practices for active substance;
manufacture of APIs includes a 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
medicinal substances and excipients. "

Existing letters l) to s) are renumbered q) to x).

126th Under § 64 the following § 64a is added:

"§ 64a

(1) Safety features according to § 37 para. 7 may not be wholly or partly
removed or covered, except when doing so if the manufacturer and


A) prior to partly or fully removing or covering those
protective elements verify that the medicinal product concerned is authentic and that it has not been tampered
,

B) meet the requirements of § 37 para. 7 by replacing those
protective elements equivalent safety features; This replacement must be done without disrupting
inner packaging and

C) the replacement of the safety features is conducted in accordance with good manufacturing practice
medicines.

(2) The safety features according to paragraph 1. b) be considered equivalent if


A) meet the requirements specified in the regulations or guidelines adopted
Commission

B) are equally effective for verifying the authenticity of medicinal products and their identification and


C) are in the same range capable of proving that they had been tampered with
. ".

127th In § 66 para. 1, at the end of subparagraph b) the semicolon replaces the word "
," and the following letter c), which reads:

"C) wrapping the medicine was provided with protective elements according to § 37 paragraph
. 7. ".

128th In § 66 para. 1 of the final provisions of the word "if"
replaced by the word "if".

129th In § 67 para. 4 point. l) the words "paragraph. 5 point. a) to c) "
replaced by" paragraph. 6 point. a) and b). "

130th In § 67 at the end of paragraph 5 is replaced by a comma and
letter d), which reads:

"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 service, which draws blood. ".

131st In § 69 par. 3, the words "l), m) as)" is replaced by "q), r)
x)".

132nd Under § 69 the following § 69a and 69b, which including the title added:

"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 products
apply § 78 para. 2 and 3 accordingly. ".

133rd § 70 reads:

"§ 70

(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 the

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
considered 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. ".

134th In Part one, Title IV, Part 2 Section 2 reads: "
distribution of medicines and their mediation."

135th The heading of § 75 reads: "The provisions on the distribution of medicinal products and their
mediation".

136th In § 75 para. 6 of the first sentence the words "putting all the places in which they can perform
distribution of medicinal products" is replaced by "putting
approved storage facilities in the Czech Republic for which it is valid
" .

137th In § 77 par. 1, letter b) reads:

"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 ".

138th In § 77 par. 1 point. c) the words "
distribute medicinal products", the words "unless the export to a third country."

139th In § 77 par. 1 point. c) Section 2 reads:

"2. persons who are authorized to issue medicines or
vendors of selected medicinal products, in the case of reserved
medicinal products ".

140th In § 77 par. 1 point. c) Section 3, the word "infusion" are inserted
words "hemofiltration or dialysis."

141st In § 77 par. 1 point. f) after the word "Constitution" and the words
"Veterinary Institute" the words "complete and correct" and
word "service" the words "other distributors."

142nd In § 77 par. 1 point. g) after the word "requirements" the words "
on securing the services of a qualified person."

143rd In § 77 at the end of paragraph 1 is replaced by a comma and
letters j) to o) are added:

"J) if the medicinal product is obtained from another distributor,
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
. '.

144th In § 77 par. 1 at the end of the letter) is replaced by a comma and
subparagraph p), which reads:

"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.".

145th In § 77 par. 3, second sentence, the words "about the product"
words "including batch number" and the words "or customers
medicinal product" is replaced by "a purchaser of a medicinal product, place
delivery "and at the end of the paragraph, the sentence" In the case that the medicinal

Product drawn pharmacy operator, who is also the holder
distribution authorization must be mentioned in this document, whether
purchaser takes medicines as an operator of a pharmacy or a
distributor. ".

146th In § 77 par. 5 point. b) the word "set" is replaced by
"set".

147th In § 77 par. 5, point c) deleted.

Existing letter d) is renumbered as point c).

148th In § 77, paragraphs 7 and 8 are added:

"(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 regulations of the European Union
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). ".

149th Under § 77, the following new § 77a and 77b, which, including the title added:

"§ 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. ".


150th In § 78 par. 3, the first sentence following the sentence "In any case
changes in reported data from the notifier Veterinary Institute
promptly complete an updated notification.".

151st In § 79 at the end of paragraph 6 the sentence "The same person may be appointed
chief pharmacist for only one pharmacy.".

152nd In § 79 para. 10 first sentence the words "health care workers"
replaced "by health care professionals
credential provider of health services" in the second sentence, the words "manner provisions
pharmacist," are deleted.

153 above. In § 80, the existing text becomes paragraph 1 and the following
paragraph 2, which reads:

"(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. ".

154th § 80 reads:

"§ 80

(1) Medicines prescribed by doctors to their expertise
providing medical services and prescription
issued in electronic form. Issuing a prescription in paper form
is permitted only in exceptional cases where, for objective reasons, can not be
expose the prescription electronically.
Implementing legal regulation stipulates the circumstances in which the issue of prescription
in paper form is always permissible.

(2) If a prescription electronically to
individual patient (hereinafter "electronic prescription") is
prescribing physician must send it in accordance with § 81 into a central repository of electronic
recipes, which he promptly communicate identification
character that is stored electronic prescription provided. This
identification mark, on the basis of the prescribed medicine at the pharmacy
issued prescribing physician must advise the patient.
The 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
provides prescribers doctors 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. Implementing legislation also provides for a method
dealing with recipes that have been in accordance with paragraph 1
issued in paper form.

(3) 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.

(4) Veterinary medicines prescribed by their expertise
veterinarians prescription issued in paper form.

(5) when prescribing medicines for human use, physicians are obligated to follow
so, that ceded the advantage
provider of pharmaceutical care or interference with the rights of patients to choose providers
pharmaceutical care. Advertising ^ 51) in connection with an electronic recipe
is prohibited. ".

155th In § 81 paragraph. 1 at the end of the text in subparagraph d) the words ";
Also secure access to the database free of charge electronic prescriptions
insurance companies for the purpose of carrying out inspection activities in accordance
law regulating public health insurance. "

156th In § 82 para. 1 first sentence, the words "go to" insert the word
"valid" and the first sentence, the following sentence "
Medicines containing narcotic or psychotropic substances, which can be issued only on prescription | || blue stripe under a special law, can not go on
prescription issued in another Member State.
Method of prescribing data indicated on the prescription and usage rules
prescriptions in the implementing legislation. ".

157th In § 82 para. 1, first sentence, the words ", which can be in paper or electronic form
recipe" are deleted.

158th In § 82 at the end of paragraph 1 the sentence "go to your valid

Prescription is also dispensing medicinal product pursuant to § 39 par. 4
prescribed by a doctor without specialist competence. ".

159 aircraft. In § 82 para. 2 at the end of the text of letter b) the words "with the exception
medicines without a prescription
with limitations."

160th In § 82 par. 3 point. b) the words ";
implementing legislation provides for pharmacies, scope and method of collection from another pharmacy "
replaced by" in accordance with paragraph 4 ".

161st In § 82 par. 3 point. e) after the word "lead" the words "
complete and conclusive".

162nd In § 82 at the end of paragraph 3 is replaced by a comma and
letters f) and g), as follows:

"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. ".

163rd In § 82 paragraph 4 reads:

"(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. ".

164th In § 83 paragraph. 1 sentence after the semicolon is replaced by "when
medicines were dispensed in a pharmacy is obliged to act in accordance with set
classification of the medicinal product in accordance with § 39. If
medicine categorized dispensing without a prescription and the patient
such issue requires operator of a pharmacy may not make
release medicine patient prescription submitting
without prior assessment of whether, in this case those limits are respected
. '.

165th In § 83 after paragraph 5, the following paragraphs 6 and 7 are added:

"(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. ".

Existing paragraph 6 shall be renumbered 8th

166th In § 84 par. 3, the following sentence added after the first sentence, "The notification of commencement
mail-order dispensing with the address of the website,
If the pharmacy will be offered Medicinal Products for dispensing
public at a distance by electronic means ; In such a case
pharmacy is required to notify the Department of a change such addresses, and it
later than 15 days from the date when such a change occurred. ".

167th In § 84, the following paragraph 4 is added:

"(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 EU 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. ".

168th In § 85 para. 1 first sentence, the word "registration" the words
"is not restricted according to § 39 par. 5 or '.

169. In § 85 par. 2 point. d) the word "effects" the words "and
quality defect."

170th In § 85, paragraph 3 shall read, including footnotes.
93 reads:

"(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).

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. ".

171st In § 87 para. 1 introductory part of the provision reads:

"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 only be
medicines ".

172nd In § 87 para. 1, letter c) reads:

"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".

173rd In § 87 paragraph 3 is deleted.

174th In § 88, the following paragraph 5 is added:

"(5) The provisions of paragraphs 1 through 4 shall apply mutatis mutandis to the management of
such products have not been marketed as medicines
but it was about them, according to § 13 para. 2 point. h) or pursuant to § 16 para. 2
point. f), that they are medicinal products. ".

175th In § 89, paragraph 3 shall be added:

"(3) if a withdrawal of a medicinal product from the market
holder of the marketing authorization does not apply to operators paragraph 1. Operators
act of presentation of unused medicines by
instructions MAH that 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 insurers 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
out of circulation. ".

176th § 90 and 91, including footnote no. 94 added:

"§ 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 options to reduce

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.

94) Art. 108 and Art. 108a of the European Parliament and of the Council
2001/83 / EC as amended by Directive of the European Parliament and of the Council
2010/84 / EU. ".

177 cells. Under § 91 the following § 91a, including the heading reads:

"§ 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. ".

178th § 92 and 93 including the title added:

"§ 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 in accordance with the 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. ".

179th Under § 93, the following new § 93a to 93k, which
including headings and footnotes. 95-98 added:

"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 that occur
in 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

Submission of these 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; At the same time they are obliged

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 medicinal product

C) refusal to renew a registration, or

D) adding new contraindications, a reduction in the recommended dose or restrictions
indications.

(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 already
asked.

(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.

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 that
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.

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. ".

180th In § 93i, paragraph 1 reads:

"(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 the 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. ".

181st In § 93i at the end of the text of paragraph 2 the words "or
did not apply for an extension."

182nd In § 93i paragraphs 6 and 7 are added:

"(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. ".

183rd In § 95 paragraph 2 reads:

"(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. ".

184th In § 96 paragraph 3 and 4 added:

"(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 of any infectious disease agent
medicinal product, which has occurred on the territory of a third the country 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
. ".

185th In § 96 para. 6 the words "pursuant to § 92 paragraph. 8 similarly"
replace the words "also to the competent authorities of the European Union and its Member States under the guidance
Commission and the Agency."

186th In § 97 paragraph 3 and 4 added:

"(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 MAH . 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. ".

187th In § 98 paragraph. 2, the second sentence is replaced by the phrase "
Veterinary Services are required to immediately transmit the information they received veterinary
devices in their scope, if not already
Veterinary Institute in paragraph 1".

188th The 99 par. 1 letter c) reads:

"C) the list of medicinal products registered in the Czech Republic and the European Union
resolution, whether the medicines
restricted to prescription or prescription restricted, with the possibility
dispensing without a prescription or without a prescription
restrictions or reserved medicines, to ensure the availability
relevant summaries of product characteristics and the package leaflet. "

189th In § 99 para. 1, at the end of letter f) the following section 5 is added:

"5. authorized hospital exemptions for medicines for advanced therapies
".

190th In § 99 at the end of paragraph 1 is replaced by a comma and a letter
o) is added:

"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
person if it is a legal person. ".

191st In § 99 par. 2 at the end of the text of letter b) the words "and
information about the initiation of administrative proceedings based on applications submitted
authorization or notification of a clinical trial."

192nd In § 99 par. 2 point. e) the word "legitimate" is replaced by
"legitimate".


193rd In § 99 par. 2 point. f) the word "system" is replaced
"system or information."

194 cm. In § 99 par. 2 letter i) reads:

"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 with
stating the reason for their early termination ".

195th In § 99 par. 2 the following point j) is added:

"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. ".

196th In § 99 para. 3 sentence, third to fifth sentences are replaced by "
Institute or the Veterinary Institute shall make publicly available the
authorization together with the package leaflet and the summary of product characteristics and
setting any conditions and obligations under § 31a, § 32 paragraph
. 3 and § 32a indicating any deadlines for the fulfillment of these conditions
and obligations for each medicinal product which they have authorized.
Institute or the Veterinary Institute furthermore shall make public a report on the evaluation of medicinal product
according to § 31 para. 8
reasons for its opinion after deleting any information
having the nature of a trade secret under special laws ^ 55).
Justification must be processed separately for each indication.
Unbundled assessment report of the medicinal product in accordance with § 31 para. 8
contains a summary of the assessment processed in a way understandable
general public, the summary shall include in particular information regarding
conditions of use of the product. ".

197th In § 99, the following paragraph 6 is added:

"(6) The information resource of the Institute for remote access is
linked to the European web portal for medicines
formed in accordance with applicable regulations of the European Union regulating the procedure
registration 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. ".

198th In § 100, paragraph 8 shall be added:

"(8) The 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. ".

199th Under § 100, the following new § 100a, which reads:

"§ 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
associated risks. ".

200th In § 101 paragraph 3 reads:


"(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. ".

Two hundred and first In § 101 para. 4 introductory part, the words "and other persons
TREATING drugs" is replaced by "other persons handling
drugs with marketing authorization holders, manufacturers and importers
auxiliary agents and brokers ".

202nd In § 101 at the end of paragraph 4 is replaced by a comma and
points g) and h) are added:

"G) when checking mail-order dispensing performed by delegation
test purchase or act as an ordering of medicines, which are subject
mail-order dispensing,

H) carry out checks on the premises, records, documents and basic document
pharmacovigilance system of marketing authorization holders or any
entities MAH
used to perform the activities specified in Chapter Five. ".

203rd In § 101, paragraphs 10 to 12 are added:

"(10) If the scrutiny referred to in 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 fails to comply with laws or principles 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
.

(11) If the inspection carried out pursuant to paragraph 4. a)
Department finds that the marketing authorization holder does not comply
pharmacovigilance system as described in the pharmacovigilance system
obligations laid down in Chapter Five, highlights these shortcomings
holder of the marketing authorization. Along with this warning Institute informs
facts ascertained by the competent authorities of other Member States
Agency and the Commission shall take the necessary measures, including
application of sanctions.

(12) check the relevant institute carried out in accordance with Commission guidelines, if
been for the type of control issue. ".

204th § 101 including the title reads:

"§ 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 reporting on planned and executed

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 arising 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 regulation 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, a statement of checks for the past calendar year 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 the 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
been for the type of control issue. ".

205th In § 103 at the end of paragraph 1 is replaced by a comma and
subparagraphs c) to f) are added:

"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. ".

206th In § 103. 2, the word "plasma" is replaced by "
raw material for further production," and the number "7" is replaced by "8".

207th In § 103 paragraph. 4 point. b) the word "notification" the words
"or an updated notification."

-208. In § 103 paragraph. 4 at the end of subparagraph c) the word "or" is deleted.

209th In § 103 at the end of paragraph 4 is replaced by a comma and
words "or provide mail-order dispensing medicines without
to do so pursuant to § 84 par. 2 person authorized, or".

210th In § 103 at the end of paragraph 4 the following point e), added:

"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. 8.".

211th In § 103. 5 at the end of the text of letter a) the words "or
§ 79 par. 10".

212th In § 103. 5 at the end of the text of letter b) the words "or
contrary to § 8. 5 notifies the prescription or use
unauthorized medicinal product".

213th In § 103. 6 letter a) reads:

"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) ".

214th In § 103. 6 point. d) after the word "shall", the words "
on the market."

215th In § 103. 6 point. e) and § 104. 8 point. e) the words
"paragraph. 5 "is replaced by" paragraph. 6 '.

216th In § 103. 6 at the end of paragraph e) the word "or" is deleted.

217th In § 103 at the end of paragraph 6 dot replaced by "or" and
subparagraph g), added:

"G) violates the prohibition distribute medicines which went as a
operator of a pharmacy in accordance with § 82 para. 4. '.

218th In § 103. 9 of the introductory part, the words "pursuant to § 82 para.
2" are deleted.

219th In § 103. 10 letter b) reads:

"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" .

220th In § 103. 10 letters e) and f) are added:

"E) issues a medicinal product to another pharmacy or provider-patient care
contrary to § 82 para. 4 or contrary to § 82 par. 3 point. F)

Fails to make all necessary arrangements to exchange the product for
which the defect was detected in quality

F) does not proceed in the dispensing of medicine in accordance with the rules laid
§ 83 paragraph. 1-7 ".

221st In § 103. 10 letter g) shall be deleted.

Existing letter h) shall become point g).

222nd In § 103, at the end of paragraph 10 of the dot replaced by "or" and
subparagraph h), which reads:

"H) in the event that 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 par. 3 point
. G).".

223rd In § 103. 11 at the end of the text of letter b) the words "or
limited according to § 39 par. 5".

224 '. In § 103. 11 at the end of subparagraph g) the word "or" is deleted.

225th In § 103, paragraph 11 at the end of the period is replaced by the word "or" and
subparagraph i), which reads:

"I) ensuring that a website providing mail-order pharmacy dispensing
contained information according to § 85 para. 3.".

226th In § 103. 12 letter. a) the words "satisfy the condition," added
word "acquisition".

227th In § 103. 12 at the end of the text of letter a) the words "
for human or veterinary medicinal products".

228th In § 103. 12 letter b) reads:

"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
".

229th In § 103. 12 letter. e) the words "not retain proof of purchase
storage and sale of selected medicinal products for 5 years'
replaced by" does not keep records or fails to keep pursuant to § 23 para. 4
point. G)".

230th In § 103, the following paragraph 14 is added:

"(14) medical service provider commits an administrative offense by
that when prescribing medicines does not ensure compliance with the conditions
specified in § 80 paragraph. 5. '.

231st In § 104. 5 point. c) the words "point. l) "are replaced
" point. q) ".

232 interface. In § 104. 7 point. c) the words "point. r) "is replaced
" point. w) ".

23.3. In § 104. 8 point. e) the words "paragraph. 5 "is replaced by" paragraph.
6 ".

234th In § 104, paragraphs 11 to 13 are added:

"(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. ".

235th In § 105, paragraph 1 reads:

"(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. 1. ".

236th In § 105 par. 2 letter f) reads:

"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 said, ".

237th In § 105 para. 2 point. h) the words "or the active substance or excipients
substances" are deleted and the words "under § 77 par. 5 point. d) in the case of
distributor with a range of authorization including distribution of active substances and excipients
"is replaced by" as a distributor with a range
authorization including distribution of active ingredients and excipients in conflict with
§ 77 par. 5 point. c) has developed an effective system to ensure
withdrawal of the active substance or excipients from circulation or fails
specified information to their customers. "

238th In § 105 para. 2 point. k) the word "or" is deleted.

239th In § 105 at the end of paragraph 2 is replaced by a comma and

Subparagraphs m) to q) are added:

"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. 3. ".

240th In § 105 para. 5 at the end of the text of letter c) the words "
4 or 5".

241st In § 105 para. 5 letter d) reads:

"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 medicinal products ".

242nd In § 105 para. 5 at the end of the text of letter e) the words "or
implement measures to ensure that a replacement medicine or
fails to complete withdrawal of the medicinal product from the market, and its removal."

243rd In § 105 para. 5 at the end of the text of letter f) the words "or
notifies the competent institution a suspect quality defects
medicinal product or excipients according to § 33 par. 3 point. and)".

244th In § 105 para. 5 letter h) reads:

"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. "

245th In § 105 para. 5 letter i) shall be deleted.

Existing letters j) to w) are renumbered i) to v).

246th In § 105 para. 5 point. i) the words "Section 4" is replaced by "point
3".

247th In § 105 para. 5 letter l) is deleted.

Existing letters m) to v) are renumbered l) to u).

248th In § 105 para. 5 point. m) the number "12" is replaced by "5".

249th In § 105 para. 5 point. n) the words "according to § 91 para. 1, or"
deleted.

250th In § 105 para. 5 point. a) the words "according to § 91 para. 3, or"
deleted.

251st In § 105 para. 5 point. p) the words "according to § 92 paragraph. 1, or"
deleted.

Was 252. In § 105 para. 5 point. q) the words "according to § 92 paragraph. 2, 3, 4 or 6
, or" are deleted.

253rd In § 105 para. 5 point. r) the words "according to § 92 paragraph. 7 or 8
or" deleted.

254th In § 105 para. 5 point. a) the words "contrary to § 92 paragraph. 10
or" deleted.

And 255. In § 105 para. 5 letter t) au) added:

"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 inform 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 ".

256th In § 105 para. 5 in the following points) to x), added:

"V) following the impact of the measures according to § 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 not the procedures for obtaining information under § 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
. ".

257th In § 105, new paragraphs 7 and 8 are added:

"(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
. 4. '.

258th In § 106, paragraph 3 is deleted.

The former paragraphs 4 to 6 shall be renumbered 3 to 5

259th In § 106 para. 5 point. a) and § 108 paragraph. 8 point. a) the words "
§ 90 paragraph. 1 point. a) "is replaced by" § 93b paragraph. 1 point. a), or ".

260th In § 106 para. 5 point. b) and § 108 paragraph. 8 point. b) the words "
§ 90 paragraph. 1 point. b), or "be replaced by" § 93b paragraph. 1 point. b) ".

261st In § 106 para. 5, letter c) shall be deleted.

262. In § 107, paragraph 1 reads:

"(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).".

263rd In § 107 par. 1 point. c) the words "§ 103. 12 letter. a) to
c) or e), "the words" § 103. 14 ".


264th In § 107 par. 2, "1-4" is replaced by "1-3".

265th In § 108 paragraph. 1 in point b) the word "plasma" is replaced
'raw materials for further manufacture. "

266th In § 108 paragraph. 1 point. e) the word "or" is deleted.

267th In § 108 paragraph. 1 at the end of the text of letter f) the words "or
provides mail-order dispensing medicines without a person to do
according to § 84 para. 2 authorized, or as a person who was | || MAH, fulfill the obligation to withdraw the medicinal product from circulation
according to § 34 para. 8 ".

268th In § 108, at the end of paragraph 1, the period is replaced by the word "or" and
subparagraph g), added:

"G) places on the market counterfeit medicine.".

269th In § 108 paragraph. 2 at the end of the text of letter a) the words "or
§ 79 par. 10 or prescribe medicine to medical prescription
restrictions inconsistent with § 39 par. 4, or prescribing
preparations proceed contrary to § 80 paragraph. 1 ".

270th In § 108 paragraph. 2 at the end of the text of letter b) the words "or
contrary to § 8. 5 notifies the prescription or use
unauthorized medicinal product".

271. In § 108, paragraph 5 shall be deleted.

Existing paragraphs 6-10 shall be renumbered 5 to 9

272nd In § 108 paragraph. 7, point c) deleted.

273rd In § 108, paragraph 8 reads:

"(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).".

274th In § 108 paragraph. 9, the words "to 6" is replaced by "to 5".

275th Under § 111, the following new § 111a, including the heading reads:

"§ 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
. ".

276th In § 112 at the end of the text of paragraph 5, the words "
conducted under this Act or under special legal regulations 99)
You can not use this action to ensure the necessary extent of the budgetary resources
".

Footnote. 99 reads:

"99) For example, Act no. 48/1997 Coll., As amended,
Act no. 123/2000 Coll., As amended, Act no. 40/1995
Coll. as amended, Act no. 167/1998 Coll., as amended
amended, Act no. 265/1991 Coll., on the competence of the Czech Republic
on prices, as amended, Act No. .
526/1990 Coll., as amended. ".

277th In § 114 paragraph. 1, "§ 24 par. 2, 3, 4, 7 and 8" are replaced
words "§ 24 par. 2, 3, 4, 8 and 9".

278th In § 114 paragraph. 2, "§ 26 par. 5 point. l) "are replaced
" § 26 par. 5 point. n) ", the words" § 30. 3 and 7 'are replaced by' §
30 paragraph. 3 ", the words" § 33 par. 3 point. g) Point 4 "is replaced by" §
33 paragraph. 3 point. g) Point 3 ", the words" § 34 para. 1, "the words" and 3, §
35 paragraph. 2, 3 and 12 "shall be deleted and the words" § 39 par. 4 "is replaced by" § | || 39 paragraph. 5 ", the words" § 49 para. 5, "the words" § 49b paragraph.
2 ", the words" § 59 para. 1, "the words" § 59a . 3, "for
words" § 64 point. j) "the words" k) q) "is replaced by" and) "
words" § 70 para. 4 "is replaced by" § 70 para. 1 ", the words" § 82

Paragraph. 3 point. b) "is replaced by" § 82 par. 3 point. f) ", the words" §
83 paragraph. 1 to 3, § 83 paragraph. 5 point. b) "is replaced by" § 83 paragraph.
2, 3, 5 and 7 'and the words' § 91 para. 2 point. b) § 92 paragraph. 11 and 12 "shall be replaced
'§ 91 para. 2 point. f) § 93j paragraph. 1, § 95 para. 2
point. b) ".

279th In § 114 paragraph. 3, the word "Interior" comma replaces the letter "a"
and the words "and the Ministry of Finance" shall be deleted.

Art. II

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. III
Efficiency


This Act shall take effect on the second day of the calendar month
following the date of its publication, except

A) of Article I, para. 133 in terms of § 70 para. 3-6, which takes
force on 2 July 2013

B) of Article I, para. 101, 126 and 127, which come into effect upon the expiration of 3 years from the date of publication
acts issued by the European Commission under delegated powers
under Article I, section 12 of the Directive of the European Parliament and Council Directive 2011/62 /
EU of 8 June 2011 amending Directive 2001/83 / EC on the Community Code
relating to medicinal products for human in terms of
preventing falsified medicines entering the legal supply
chain; day or days when these acts were announced,
notify the Ministry of Health in the Collection of Laws,

C) of Article I, para. 84, 96 and 248, which come into effect on August 4
2013

D) of Article I, para. 70, 78, 109, 112, 144, 180-182 and 240, which come
effective on October 28, 2013,

E) of Article I, para. 204, which comes into effect on January 1, 2014, and

F) of Article I, para. 154, 157, 230 and 263, which come into effect on 1 January 2018.

Nemcova vr

Klaus vr


Nečas

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