167/1998 Coll.
LAW
of 11 December 1997. June 1998
about addictive substances and amending some other acts
Change: 354/1999 Coll.
Change: 117/2000 Sb.
Change: 132/2000 Sb.
Change: 57/2001 Sb.
Change: 117/2000 Coll. (part)
Change: 185/2001 Coll., 407/2001 Sb.
Change: 320/2002 Coll.
Change: 223/2003 Coll.
Change: 362/2004 Sb.
Change: 362/2004 Coll. (part)
Change: 228/2005 Sb.
Change: 74/2006 Sb.
Change: 124/2008 Sb.
Change: 141/2009 Sb.
Change: 291/2009 Sb.
Change: 41/2009 Sb.
Change: 281/2009 Sb.
Change: 106/2006.
Change: 341/2010 Sb.
Change: 375/2007 Sb.
Change: 167/2009 Sb.
Modified: 18/2012 Sb.
Change: 50/Sb.
Change: 273/Sb.
Change: 50/2013 Coll. (part)
Parliament has passed the following Act of the United States:
PART THE FIRST
TITLE I OF THE
INTRODUCTORY PROVISIONS
§ 1
The subject of the edit
(1) this Act regulates the
and treatment of addictive substances), their export, import and transit
operations with them,
(b)) treatment preparations containing addictive substance, with
containing the addictive substance, and substance of category 1 according to directly
of the applicable legislation of the European Union regulating drug precursors ^ 1)
(hereinafter referred to as "listed substance in category 1") and medicinal products
containing that substance in category 1, their export, import and
transit operations with them and
(c)), cannabis and poppy cultivation of coca and the export, import and disposal of
poppy concentrate.
(2) this Act has been notified in accordance with the directive of the European Parliament
and Directive 98/34/EC of 22 December 2004. June 1998 on the procedure for the provision
information in the field of standards and technical regulations and rules on services,
the information society, as amended.
§ 2
The concepts of
For the purposes of this Act, means the
a) narcotic drugs and psychotropic substances referred to in
Annexes 1 to 7 of regulation the Government about a list of substance abuse,
(b)) with a solution or mixture, in any physical condition that contains
the addictive substance or the addictive substance, and substance of category 1 or
a medicine according to the law on medicinal products containing that substance
category 1,
(c) makovinou all of the above-ground parts) (excluding seed) poppy (Papaver
somniferum l.), as well as their chips after harvesting, with the exception of whole
poppy plants including capsules, intended for ornamental purposes,
d) cannabis flowering or its vrcholík plants of the genus cannabis
(Cannabis) or above-ground part of the plant of the genus cannabis, part of which is
vrcholík,
e) coca bush of the genus Erythroxylon all kinds of bushes and a sheet of coca leaves
from the coca bushes, with the exception of sheets, from which was extracted all the ekgonin,
cocaine and other alkaloids, ekgoninové ^ 2a)
f) export or import of addictive substances, preparations containing them, and
poppy concentrate their physical movement from one State to another.) ^ ^ 2a, 2 c)
TITLE II
TREATMENT OF ADDICTIVE SUBSTANCES AND PREPARATIONS
§ 3
Treatment of addictive substances and preparations
(1) the treatment of addictive substances and preparations ' means
and) research, production, processing, consumption, storage, supply and use of
addictive substances and preparations,
(b)) the buying and selling of addictive substances and preparations, as well as the acquisition and
loss of other material or contractual rights associated with them,
brokering such contracts and representation in their conclusion.
(2) Addictive substances listed in annex No. 3 or 4 Government regulation of
list of addictive substances and preparations containing them can be used
only limited research, scientific and very limited therapeutic
purposes set out in the authorization to the treatment. Other addictive substances and
preparations containing them can only be used for therapeutic,
the scientific, training, veterinary purposes or for other purposes to
with the permission of the Ministry of health.
section 3a
cancelled
§ 4
The authorization to the treatment
For the treatment of addictive substances and preparations it is necessary to permit
treatment, unless otherwise provided by this act otherwise.
§ 5
Treatment of addictive substances and preparations without permission to treatment
(1) the Addictive substances listed in Appendix 1, 2, 5, 6 or 7 of regulation
Governments on the list of substances and preparations containing them or healing
preparations containing scheduled substances of category 1 may without a permit to
treatment
and) to purchase, shriveled and store the persons providing pharmaceutical care ^ 2e)
only for the operation of pharmacies,
b) disposing of, if they are not held, of the person authorized to do so under
a special law, ^ 3)
(c)) to prepare the pharmaceutical forms in pharmacies or pharmacists
pharmaceutical assistants under the supervision of a pharmacist.
(2) preparations containing addictive substances listed in Schedule 1, 2, 5, 6
or 7 Government regulation about the list of addictive substances and medicinal products
containing scheduled substances of category 1 may, without the authorisation of the treatment
and) only for provision of health services to acquire, shriveled and
store providers of health services or persons carrying
device providing residential social services,
(b)) only for the provision of health care to acquire, shriveled and store
a natural or legal person authorized to perform the professional veterinary
activities,
c) prescribe doctors in provision of health services in the
health care facilities and in facilities providing social services,
d) use for therapeutic purposes, doctors and other health care
workers in health care facilities beds and ambulatory care and in
devices providing residential social services or doctors who
they have concluded a contract on the prescribing of medicinal products to health
insurance company,
e) to prescribe and use for the purpose of veterinary treatment veterinary
doctors, ^ 4)
f) according to the physician filled out and signed form (the recipe-based
"the recipe") or providers of health care services or order
natural and legal persons authorized to provide veterinary care
(hereinafter referred to as "requisition") to prepare and issue the pharmacists in pharmacies,
g) accept in pharmacies, pharmacists or pharmaceutical assistants under
the supervision of a pharmacist,
h) acquire, even by proxy, based on doctor issued prescription,
store and use according to the issued of the recipe for their own physical
of the person,
I) to acquire, even in the representation, based on a recipe of the veterinary
doctor or acquire from a natural or legal person entitled to exercise
veterinary activities, store and use in accordance with the issued recipe
or according to the set of diagnosis for the purposes of the provision of veterinary care
natural and legal persons,
j) acquire, shriveled, store, transport and use, the contracting authorities and
the investigator in preparing and conducting a clinical trial of human
drugs under a special law, ^ 5)
k) acquire, shriveled, store, transport or use of contracting authorities
or the investigator in the preparation or conduct of the trial
veterinary drugs under special legislation. ^ 5a)
(3) the authorization to the treatment does not require transport substance abuse and
preparations, carried out for the person who is entitled to the treatment
addictive substances and preparations.
(4) without the authorization of the treatment can be transported in means of transport
intended for international transport limited quantities of products containing
addictive substances listed in annex No. 2, 6 or 7 of the Decree of the Government of
list of addictive substances and medicinal products containing those substances
category 1 for first aid and for urgent cases.
(5) the permit is not required to obtain treatment, storage, and
processing of the cannabis plant, which can contain up to 0.3% of substances in
the Group tetrahydrokanabinolů, and only for the purposes of industrial hemp,
technical and gardening, as well as the trade in cannabis for these purposes.
(6) the authorisation for treatment is not required for the activity of the public authorities in the
the framework of their competence, for the operation of territorial self-governing units in
under their delegated responsibilities and in ensuring the local
a matter of public policy in their individual scope and for
the activities of the army of the Czech Republic, police of the Czech Republic, the General
inspection of security forces, the prison service of the Czech Republic and Customs
administration of the Czech Republic in the performance of their duties.
(7) authorization for treatment is not required for the activities of legal entities or
natural persons who establish judicially Toxicology lab,
the laboratory of the health institutes, specialized diagnostic,
research and teaching departments of universities and specialized
diagnostic and scientific-research of the Academy of Sciences of the Czech
States, the list of which the Ministry of health shall lay down by Decree.
Application for inclusion to this list and a request for amendment of the particulars referred to in
the list shall be made on a form issued by the Ministry of health.
(8) any changes to the information specified in the list referred to in paragraph 7 is a person
included in the list shall forthwith in writing inform the Ministry of
the health sector.
(9) the authorization to the treatment is not required for a person operating a pharmacy,
which shall take, and stored the addictive substances listed in the annexes to
No. 3 and 4 Government regulation about the list of substance abuse with a view to their
delivery of the persons referred to in paragraph 7.
(10) the Addictive substances listed in annex No. 3 or 4 Government regulation of
list of addictive substances and preparations containing them may without a permit to
treatment of disposing of, if they are not stored, the person on the basis of
consent granted regional authority ^ 3). To grant consent shall inform the
Regional Office, which has granted approval, the Ministry of health. This
information is given on a form issued by the Ministry of health.
§ 6
cancelled
§ 7
The Ministry of Health decree may lay down other cases in which
to the treatment of addictive substances and preparations to which does not require a permit to
treatment.
§ 8
The issuance of permits to the treatment
(1) a permit issued by the Ministry of health to treatment. Authorisation to
treatment is not issued if the person fails to comply with the requirements for the application
in accordance with paragraph 6.
(2) the authorization to the treatment of warrants only to the activities referred to therein, and
in the case of a permit to manufacture, can be determined by the highest
the allowable volume of production of addictive substances or products. The release of the new
the authorization to the treatment of existing authorization expires for the treatment.
(3) the authorization to the treatment of addictive substances and preparations shall be issued
for a maximum period of 5 years.
(4) the authorization to the treatment is non-transferable.
(5) the authorisation to treatment may only be issued legal or natural
to the person who established the responsible person. This does not apply if the physical
person-entrepreneur proves that complies with the responsible
a person of this Act.
(6) an application for the authorization to the treatment is given on a form issued by the
The Ministry of health. The application shall be
and, a copy of) the original or officially certified copy of the decision confirming the
the authorization to the treatment of drugs according to the law on pharmaceuticals or certificate of
compliance with the conditions for the performance of veterinary therapeutic and preventive activities
under the law on Chamber of veterinary surgeons,
(b)) evidence of integrity, if it is not possible under section 8a of the paragraph. 4,
c) proof of business permit,
(d)) the document containing the property owner's consent to the activities
referred to in the request,
e) contract for professional veterinary activities, if this activity
exercised,
f) proof of the provisions of the responsible person referred to in paragraph 5,
g) proof of medical fitness under section 18,
h) proof of professional competence pursuant to § 7 para. 1,
I) Declaration by the applicant that, in the case of activities which comes
into direct contact with addictive substances and preparations will be elected
the appropriate way to their security pursuant to section 10 and 11,
(j) a description of the intended production technology), in respect of an application for authorisation to
the production of addictive substances and preparations.
(7) the person to whom the permit expires the treatment and intends to also
continue to treat addictive substances and preparations is required to pass the
The Ministry of health request for the issue of a new permit for treatment
no later than 6 weeks before the expiry date of the authorization to the treatment.
(8) any changes to the information provided in the application for a licence to
treatment is a person to whom authorisation was granted to the treatment required to
the Ministry of health in writing without delay.
(9) in the case of changes to the information provided in the application for a licence to
treatment related to the changes
and no longer permitted activities) or their extension,
(b)) in the name, location, legal status and identification number of the person, if it is a
a legal person, or
(c)) domicile and place of business, if different from the residence, in the case of
a natural person,
the person wishing to make these changes to submit to the Ministry of
health care a new application for the issue of permits to the treatment.
(10) the breaches of obligations arising from this Act or from the
decision issued on its basis, as well as incorrect
or incomplete information in the application for the authorization to the treatment, you may
The Ministry of health to decide on the withdrawal of the authorization to the treatment.
Ministry of health permission to treatment to be withdrawn if the
the permit holder has been finally convicted of a criminal offence, the factual
the nature of the activities related to this. ^ 5 d)
(11) if the natural or legal person to exercise the activity, to
that authorisation was granted to her treatment, it shall notify the
immediately to the Ministry of health that the authorization to the treatment of your
cancels the decision. Request for cancellation of the authorization to the treatment is served on
a form issued by the Ministry of health.
(12) if the Ministry of health of the withdrawal of the authorisation to
treatment or the new treatment, issued the permit, or by its decision
the authorization to the treatment of cancelled, shall be determined in the decision of the time-limit for the implementation of operations
associated with the termination of the activities and the way it has with addictive
substances and preparations.
(13) a person who has been issued a new authorisation for treatment, is required to
return invalid authorization to the treatment of the Ministry of health up to 14
days from the date of acquisition of legal power of the new authorisation for treatment. This
the obligation also applies to persons to whom the residence permit expires
the treatment referred to in paragraph 7 and which already do not intend to continue to treat
with addictive substances and preparations; the deadline for returning the invalid permit
the treatment is 14 days from the date of expiry of the authorization to the treatment.
§ 8a
Integrity
(1) the authorization to the treatment may be issued only to a natural person of good repute,
that has permanent residence in the territory of the Czech Republic, or good repute
a legal person with a registered office in the Czech Republic. The condition of permanent residence
or offices in the Czech Republic shall not apply in the case of a person who
has a permanent residence permit or residence, place of business, residence,
Central Administration, principal place of business or
organizational folder in the territory of another Member State of the European Union,
Contracting State to the agreement on the European economic area or the Swiss
the Confederation.
(2) the integral for the purposes of this Act, a person who was not
convicted for an intentional or negligent criminal act committed in
with regard to the treatment of addictive substances or preparations.
(3) the integrity of the shows
and an excerpt from) criminal record, not older than 3 months
1. for natural persons with permanent residence or other place of residence on the territory
The United States,
2. in the case of a natural person is or was a national of another
the Member State of the European Union or in another Member State of the European Union
has or had a place of residence,
3. for legal entities established on the territory of the Czech Republic,
(b) a similar statement from the document), criminal records
1. for natural persons with permanent residence or other place of residence outside
the territory of the Czech Republic and at the physical person in the last 5 years
continuously resided outside the territory of the Czech Republic for more than 6
months; document comparable to extract from the criminal register must be
issued by the competent authority of the State of permanent or other residence of this
persons, States in which this person in the past 5 years
continuously resided for more than 6 months, and a State which is not
the same as the State of permanent residence or other residence of that person and this
the person is its citizen,
2. in the case of a legal person located outside the territory of the Czech Republic; document
similar to the extract from the criminal register must be issued to
the legitimate authority of the State of the registered office,
(c) a sworn declaration of integrity)
1. in the case of a natural person, the State of permanent residence or other residence
natural persons and the State, where the natural person in the last 5 years
the 24-hour visa, the document referred to in subparagraph (b)); affidavit of
integrity must be made before a notary public or by the competent authority
the State of permanent or other residence of that person and States in which the
This person in the past 5 years continuously resided for a period longer
than 6 months,
2. in the case of a legal person, does not make the State of the seat of the legal person document
referred to in subparagraph (b)); affidavit of integrity must be made
before a notary public or by the competent authority of the State of residence.
(4) in order to demonstrate the integrity of the persons referred to in paragraph 3 (b). and)
1 and 3, the Ministry of health provides under a special legal
prescription ^ 5f) an extract from the criminal register. Extradition request listing
of convictions and an extract from the criminal register with
to be transmitted in electronic form, in a manner allowing remote
access. The Ministry of health may obtain any other
supporting documents, where necessary to verify the information referred to in paragraph
3.
§ 9
The responsible person
(1) a person who is treated with addictive substances and preparations with a basis of
the authorization to the treatment, you must have a responsible person has all the
period of validity of the authorization to the treatment. This does not apply when the issue was
the authorization to the treatment dispensed from the provisions of the responsible person referred to in section 8
paragraph. 5 the second sentence of this Act.
(2) the responsible person is responsible and for recording and documentation) the prescribed
This Act, (b)) for the implementation of reporting obligations prescribed by this
by law.
(3) the responsible person can be appointed a natural person as permanent
the stay on the territory of the Czech Republic. The condition of permanent residence in the Czech
the Republic does not apply in the case of a citizen of a Member State of the European Union
or a citizen of the United States that does not have in the territory of the Czech Republic
the stay. This person must meet prerequisites General, medical and vocational
eligibility.
(4) medical requirements, the responsible person shall carry a medical
opinion, that on the day of the provisions of the responsible person is not older than 3 months.
Opinion on the medical certificate issued by examining physician based on
the result of the medical examination or other professional examinations. For
medically qualified person responsible cannot be recognized by a person who
was reason to suspect that, in the exercise of this function would be jeopardised
her health or life, or that could arise in the performance of functions
the persons responsible in relation to the health of that person to the
threat to the health or life of other persons.
(5) the responsible person can be appointed only a staff member
the ratio of the agreed on a fixed weekly working time, or companion
a public company, the general partner of a limited partnership,
Managing Director of a limited liability company, Member of the Board of the joint stock
companies or cooperatives, Member of the Administrative Council of the community
company or representative.
(6) a person issued a permit to the treatment, is required to ensure
that the activities to which the permit is required treatment will not be
carried out without the consent of the responsible person.
(7) countersigned by the responsible person
and a request for authorization) to the treatment,
(b)), the application for an export permit or import permit,
c) reporting in the context of compliance with the obligation under this
the law.
(8) the responsible person, who is not an employee, and may waive the exercise of his
function by written notification to the person for whom the function of the person responsible
It performs.
(9) If a responsible person or person fulfilling its function under section 8 (2).
5 temporarily unable to perform its function, shall designate the person to whom it was
authorization to the treatment, without delay, a representative of the responsible person.
Appointment of a representative of the responsible person and end its function must be
immediately communicated in writing on a form issued by the Ministry of
the health sector. A representative of the responsible person must meet the prerequisites
General, medical, and professional competence laid down in this law for the
the responsible person.
(10) the person responsible fails to comply with the prerequisites or is
other reasons are permanently unable to carry out their function or gives up
performance of his duties, is the person to whom the permit was issued to the treatment,
shall within 10 days to appoint a new person and ask
The Ministry of health about the change permission to the treatment. The change request
the authorization to the treatment is given on a form issued by the Ministry of
health and countersigned by the responsible person composed it.
§ 10
Storage
(1) the Addictive substances and preparations must be stored in locked
rooms whose walls, ceilings, floors, Windows and doors are from
material znesnadňujícího penetration to the inventory of substances or in
non-communicable lockable boxes made of steel or special to
purpose made device into the locked inextricably docked
the walls, ceiling or floor made from solid materials (for example,
brick or concrete panels).
(2) the keys to the rooms in which they are stored and addictive substances
products may only be supplied to the designated persons and must be stored
separately from keys from other rooms in the building.
(3) Storage of addictive substances and preparations, as well as the production equipment to the
their production or cultivation must be protected against loss, theft
and abuse, especially 24-hour physical security, and appropriate
technical means (fencing, electronic security devices
etc.).
(4) the obligations referred to in the preceding paragraphs may not be fulfilled in the
storage, which is not subject to authorisation for the treatment. Storage in
these cases, however, it must be ensured, so that the inventory of substances
unauthorised persons do not have access. In healthcare facilities, in
establishments providing social services and for the persons authorized to
the provision of veterinary care must be stored in non-communicable
lockable metal crates of addictive substances referred to in annex 1,
3, 4 or 5 of regulation the Government about the list of addictive substances and preparations is
containing a.
§ 11
To the right
(1) the Addictive substances listed in annex No. 1, 3, 4 or 5 of regulation of the Government of
list of addictive substances and preparations containing them may be
transported only in metal containers or in
specially designed luggage bearing locking mechanism
or in an enclosed space vehicles, adjusted to
to avoid leakage of these substances outside of the enclosed space. When their
loading, transport and unloading the carrier must ensure continuous
surveillance. Transport routes must be intermittently changed and must not be
disclosed to the public.
(2) Addictive substances listed in annex No. 1, 3, 4 or 5 of regulation of the Government of
list of addictive substances and preparations containing them must be in transit
marked in such a way that it is possible to determine that this is the
substances and preparations, with the designation must be made in such a
way that unauthorized persons could not figure out what was transported.
§ 12
Shop
Addictive substances and preparations can be passed or sold only to persons
entitled to dealing with them. The same applies to the transfer of other
the rights associated with addictive substances and preparations.
section 13 of the
The forms for the recipes and requisitions with blue stripe
(1) the medicinal product in accordance with the law on medicinal products (hereinafter referred to as "medicinal
preparation "), which contains an addictive substance or substance
category 1, may be issued to a person at the pharmacy, which has not been issued
the authorization to the treatment, only on the recipe, requisition, or no prescription with
restrictions under the law on pharmaceuticals ^ 6a). In the case of a medicinal product,
that contains an addictive substance referred to in annex No. 1 or 5 of regulation
Governments on the list substance abuse, may be issued only on a prescription or
requisition marked blue stripe, oriented from bottom left to
the upper right corner, or exclusively on electronic recipe, where
so the law on pharmaceuticals ^ 6). If this is about a medicine that contains
the addictive substance referred to in annex No. 1 or 5 Government regulation about the list
substance abuse and which is also included in annex 8 of regulation
Governments on the list substance abuse, may be issued in a pharmacy on prescription
or requisition without marking the blue line.
(2) the forms of recipes and requisitions with a blue stripe designating the ordinal
numbers of the form and the code municipal office municipality with extended powers,
that is issued, are subject to registration.
(3) the forms of recipes and requisitions with a blue stripe and can order
remove from the locally competent municipal office municipality with extended
scope only the persons mentioned in § 5 para. 2 (a). a) and b) of this
the law through their authorised representatives. The next time you use
keep a register of such persons.
(4) the production and distribution of recipes and requisitions with a blue stripe secure
municipal authorities of municipalities with extended powers.
(5) income, inventories, supply, return and the depreciation of the returned
the forms of recipes and requisitions with a blue stripe lead the municipal authorities of municipalities with
extended powers. As part of this registration is done by the annual
counting on the last day of the calendar year.
(6) the Debased forms of the recipes or requisitions with a blue stripe are
the persons referred to in § 5 para. 2 (a). a) and b) of this Act are required to
deliver municipal office municipality with extended powers, which issued it.
(7) persons who no longer, fulfil the conditions set out in § 5 para. 2
(a). a) and b) of this Act, are required to surrender through
their appointed representatives of the unused or degraded forms of recipes
or requisitions with a blue stripe in the 5 days of Municipal Council of the municipality with extended
coverage that is issued. About the takeover cast forms issues
Municipal Office municipality with extended competence certificate.
(8) when the death of a person, that were released with recipes or requisition forms
blue stripe authorised agent or directly to the municipal authority of the
extended powers, is the one who lived with the deceased in the joint
households, is obliged to deliver these forms within 10 days from the date of death
authorized representative, if this is about a person who pursued an activity in a
employment relationship or similar relationship, in other cases, the municipal
the Office of the municipality with extended competence.
(9) the distribution, returns, liquidation and keeping records about the recipes and
requisitions with a blue stripe regulates special legislation. ^ 6b)
(10) a medicine that contains an addictive substance or listed
substance in category 1, shall not be issued repeatedly to one recipe.
(11) the Ministry of defence and the Ministry of Finance issued for
medical and veterinary equipment belonging to their scope
the forms for the recipes and requisitions with a blue line indicating the code corresponding
of the Ministry. For the management of these forms shall apply mutatis mutandis to the provisions of
paragraphs 2 to 8, with the place of the local authority of the municipality with extended
scope ensures that activities of the Ministry of defence or
The Ministry of finance.
§ 14
Disposal of waste and excess and unusable substance abuse and
products
(1) not applicable addictive substances and preparations, as well as the waste is
containing, must be disposed of. The person performing the disposal
unusable addictive substances and preparations and wastes containing about
It will draw up the writing.
(2) the disposal of unusable addictive substances and preparations, as well as
waste containing the drug, which are governed by a special legal
^ Regulation. 6 c)
(3) the disposal of unusable addictive substances and preparations, as well as
waste that contains that are not medicine under a special
^ 6) of the Act, may be carried out only in the presence of a representative of the regional office.
The person performing the disposal of it will draw up a record, which shall be signed by
the present representative of the regional office.
(4) in the treatment of inoperable addictive substances and preparations,
as well as waste containing, proceed as in the
management of hazardous wastes, including the keeping of records referred to in
the law governing waste disposal.
§ 15
Bans
It shall be prohibited
and) place the addictive substances and preparations in customs warehouses, free
zones and free warehouses, ^ 7)
(b)) to send addictive substances and preparations
1. by post as ordinary post,
2. through mailboxes, or
3. persons who are not entitled to treat them,
(c)) to pass in any manner to a person other mushrooms of the genus psilocybe
(Psilocybe)
(d)) to obtain opium from opium poppy (Papaver somniferum l.),
(e)) out of resin and fabric from the Group tetrahydrokanabinolů
from the cannabis plant (genus Cannabis), which does not affect the obtaining of such
substances for medical use or scientific purposes under the conditions laid down
This Act and the law on pharmaceuticals ^ 6)
f) advertising on addictive substances and preparations (EOU) support
the public under the law governing the regulation of advertising.
section 16 of the
cancelled
TITLE III
ELIGIBILITY FOR THE TREATMENT OF ADDICTIVE SUBSTANCES AND PREPARATIONS
§ 17
General eligibility
(1) the activities for which the permit is required for the treatment, as well as
activities referred to in § 5 para. 1 (b). and), para. 2 (a). a) and b) and para.
6, and which comes into direct contact with addictive substances and
products may carry on only the blameless individuals eligible for
legal capacity and over 18 years of age. Integrity is demonstrated by the way according to the
section 8a.
(2) the Assumptions referred to in paragraph 1 must also comply with the physical
persons who directly controls the execution of the activities referred to in paragraph 1.
section 18
Medical fitness
(1) the activities for which the permit is required for the treatment, as well as
activities referred to in § 5 para. 1 (b). and), para. 2 (a). a) to (g)) (a).
6, and which comes into direct contact with addictive substances and
preparations must not engage in physical person in whose body is
present an addictive substance, if it is not the presence of addictive substances
because the doctor prescribed treatment.
(2) the Assumptions referred to in paragraph 1 must also comply with the physical
persons who directly controls the execution of the activities referred to in paragraph 1.
(3) staff persons taking the activities referred to in paragraphs 1 and
2 shall undergo a medical examination at the employer's challenge
to detect the presence of drugs in the body.
§ 19
The competence of the
(1) as the responsible person can appoint a natural person who
She graduated from the master's degree programme in one of the following
areas:
and) pharmacy,
(b)) General Medicine, dental medicine, dentistry,
(c)) chemistry, or
d) veterinary medicine.
(2) any person who carries out the activity for which the permit is required
treatment, as well as the activities referred to in § 5 para. 1 (b). (a)) 2
(a). a) and (b)), and which comes into direct contact with addictive
substances and preparations shall be obliged to ensure that the natural persons who
When these activities are in direct contact with addictive substances
and products or that directly govern these activities have gained knowledge about
the nature and the effects of these substances and how to deal with them.
TITLE IV
EXPORT, IMPORT AND TRANSIT OPERATIONS
section 20
The export of addictive substances and preparations
(1) to each individual export of addictive substances and preparations is
need to enable the Ministry of health (hereinafter referred to as "export
enable the ").
(2) an export permit is not required
and for export) of proprietary medicinal products containing
addictive substances listed in Schedule 1, 2, 5, 6, 7 or 8 of the regulation of the Government
about the list of addictive substances or medicinal products containing listed
substances of category 1 if they are exported by a doctor in order to provide
first-aid or veterinarian to provide emergency
veterinary care during the transport of animals or of a natural person for his own
use in the quantity and the type corresponding to the length of the path and health
According to the set state diagnosis,
(b)) to be exported products referred to in annex No. 8 on the list of government regulations
addictive substances or medicinal products containing those substances
category 1, if the export is carried out by a person who has been issued a
permits for the handling of products listed in annex 8 of Regulation No.
Governments on the list of addictive substances or medicinal products containing
scheduled substances of category 1,
(c) to export a limited quantity of) preparations containing addictive substances
listed in annex No. 2, 5, 6, 7 or 8 of the regulation of the Government about the list
addictive substances or medicinal products containing those substances
category 1 in means of transport intended for international traffic in
the purpose of providing first aid or assistance in cases of emergency,
(d)) for export of proprietary medicinal products containing
addictive substances listed in Schedule 1, 2, 5, 6, 7 or 8 of the regulation of the Government
about the list of addictive substances or medicinal products containing listed
substances of category 1 if they are exported for the purposes of health and
the veterinary service units of the army of the United States operating in the
abroad,
e) for export of the cannabis plant, which can contain up to 0.3% of the substances
tetrahydrokanabinolů group for industrial, technical and horticultural
purposes.
(3) the export permit may be issued only on presentation of import
permit issued by the State, which is to be implemented the export, or consent
the relevant State authority of the State where you want to export, if effected
This State does not require an import permit; It must not be exceeded
the limit laid down by the International Bureau for control of narcotic substances for
the country imports ^ 8a).
(4) one copy of the export authorization shall send the Ministry of health
the competent authority of the State in which the export takes place.
(5) A copy of the export permit must be passed to the Customs Office,
which decides on release of the goods in the shipment. This Customs Office in it
indicate information about the items in the shipment.
section 20a
cancelled
section 20b
cancelled
section 21
Imports of addictive substances and preparations
(1) to each individual importation of addictive substances and preparations is
need to enable the Ministry of health (hereinafter referred to as "import
enable the ").
(2) the import permit is not required
and to import proprietary) medicinal products containing
addictive substances listed in Schedule 1, 2, 5, 6, 7 or 8 of the regulation of the Government
about the list of addictive substances or medicinal products containing listed
substances in category 1, if they are imported by a doctor in order to provide
first-aid or veterinarian to provide emergency
veterinary care during the transport of animals or of a natural person for his
use in the quantity and the type corresponding to the length of the path and health
According to the set state diagnosis,
(b)) to the importation of products referred to in annex No. 8 on the list of government regulations
addictive substances or medicinal products containing those substances
category 1, if imports are entering a person who has been issued a
permits for the handling of products listed in annex 8 of Regulation No.
Governments on the list of addictive substances or medicinal products containing
scheduled substances of category 1,
(c) to import a limited number of) preparations containing addictive substances
listed in annex No. 2, 5, 6, 7 or 8 of the regulation of the Government about the list
addictive substances or medicinal products containing those substances
category 1, in international transport in order to provide
the first assistance or help in emergencies
(d)) to the importation of the cannabis plant, which can contain up to 0.3% of the substances
tetrahydrokanabinolů group for industrial, technical and horticultural
purposes,
e) for importation of proprietary medicinal products containing
addictive substances listed in Schedule 1, 2, 5, 6, 7 or 8 of the regulation of the Government
about the list of addictive substances or medicinal products containing listed
substances in category 1, if they are imported by the Czech Army units
After the end of the Republic or to reduce their exposure abroad as
the balance of stocks, which have been for their activities.
(3) the Office shall decide on the release of the goods in the consignment, it shall
for a copy of the import permit, information about the items in the shipment and the date
release and send it to the Ministry of health.
(4) after the importation of the export Department of health returns
authorisation of the State which issued it, with a note about the actually imported
a lot of addictive substances and preparations.
section 22
Common provisions concerning exports and imports
(1) on the issue of an export permit or an import permit is not a legal
claim. Export permit or import permit is non-transferable and
is transferred to a legal successor.
(2) an application for an export permit or for an import permit shall be made on
a form issued by the Ministry of health. Changes to the data referred to in
application for the issuance of an export permit or import authorisation is a natural
or legal person shall be obliged to inform in writing the Ministry of health
not later than 5 days from the date when the changes occurred.
(3) the import permit is issued for a period of 3 months or at the request of the importer
You may also go for less. The period of validity of the export permit
According to the Ministry of health shall lay down the period of validity of the import
the authorization of the State on whose territory it is to be effected, if the exporter exports
requests a shorter period. If you export or import at this time
does not take place, the person to whom it was issued export permits or import
permit required to promptly notify the Department of it
health and return all copies of the Ministry of health
an export permit or import authorisation, including an indication of the reason why
to import or export has not taken place. The Ministry of health will return
export authorisation of the State which issued it, with a note that imports
materialized, or notify the non-export of the State on whose territory the
exports were allowed the Ministry of health.
(4) irrespective of whether it is for export or import, the consignment must be
always accompanied by an export permit, unless under the law of the State
the origin of the shipments, the export authorisation is required or determined by the different
the official procedure. Failure to comply with this obligation shall be carried out to ensure ^ 9)
or withdrawal ^ 10) shipments.
(5) on the export of addictive substances and preparations the Declaration on
placing goods under export procedure lodged with the Customs Office locally
of the place of residence or place of business of a natural person or
seat of the legal person. Furthermore, the export authorisation shall be presented according to section 20,
20a and 20b of this Act, if under this Act must be issued.
(6) upon import of addictive substances and preparations the Declaration on
the release of goods for free circulation or with the economic
effects filed with the Customs Office competent according to the place of residence or
the place of business of a natural person or the seat of the legal person. Additionally,
submit an import permit pursuant to § 21 of this Act, if it must be
under this Act is issued.
(7) the Ministry of health will decide on the refusal of requests for extradition
an export permit or import permit, of the suspension, withdrawal
or cancellation of an export permit or import permit, if this is
about
a) illicit trafficking in accordance with international treaties to which the United
Republic is bound,
(b) placing false information or) nedoplnění incomplete data in the request
an export permit or import authorisation within the prescribed period,
c) breach of the obligations arising from this Act or decision
issued on its basis, or
(d) the holder of the authorization to the treatment of) been convicted of an offence,
the facts related to this activity, unless he
looks as if he has been convicted.
Article 23 of the
Transit operations
(1) the transit operation must not be implemented without presentation of an export
the permit and shipment must always be accompanied by an export permit, unless the
According to the law of the State of origin of the consignment, the export authorisation does not require
or other official procedure is established. Failure to comply with this obligation shall
executes the ensure ^ 9 ^ 10) or withdrawal) of the shipment.
(2) the consignment shall not be unloaded during transport from the transport vehicle.
(3) the obligation referred to in paragraph 2 may not be fulfilled upon transit
the operation carried out by air, if the plane can land on the territory of the United
of the Republic.
TITLE V OF THE
HEMP, COCA, OPIUM POPPY AND THE SAME
section 24
Cannabis, coca and opium poppy
(1) it shall be prohibited
a) grow the plants species and varieties of hemp (Cannabis genus) that can
contain more than 0.3% of the substances from the Group of tetrahydrokanabinolů, with
exception of cultivation on the basis of the license granted under this Act;
the ban does not apply to the cultivation of varieties of the cannabis plant (genus Cannabis)
for research purposes, for breeding new varieties and for maintaining the
genetic diversity of scientific and research institutions established
the law or the State specified in the authorisation for the treatment
(b)) to grow plants of the genus Erythroxylon (Coca shrub)
(c)) to grow varieties of opium poppy (Papaver somniferum l.), which may, in
the dry matter of the capsules contain not more than 0.8% of morphine; prohibition does not apply
on the cultivation of varieties of opium poppy (Papaver somniferum l.) for research and
experimental purposes, for the cultivation of new varieties of plants, and for maintaining the
genetic diversity of plants by scientific and research institutions.
(2) the person cultivating opium poppy (Papaver somniferum l.) or a person who
makovinu is processed or stored, is also obliged to immediately notify the
the locally competent Department of the police of the Czech Republic all suspected
circumstances, in particular the entry of foreign people to the stand, cutting, the poppies
the theft of the poppies or unusual orders, which indicate that the same
can be used for the illicit manufacture of drugs.
(3) the same produced in the territory of the Czech Republic must be exported
or is incapacitated or is processed so that it contained the addictive substance
It was not possible to use or obtain by any technological means.
§ 24a
(1) to grow cannabis for therapeutic use can just such a legal or
entrepreneurial natural person who has been granted a license for this activity
The State Institute for drug control. Licensee may grow
cannabis for medicinal use, only if he has granted permission to
treatment of addictive substances and preparations.
(2) the grant of the licence is carried out the State Institute for drug control
selection procedure carried out under other legislation ^ 14). Selective
the proceedings will be held as two-wheel. For the first round of qualifying is determined
the assumptions of the specifications and technical conditions, including the rules
proper production practice, in which the candidate proceeds to
in the second round. The course may be just such a person, who proves
prerequisites ensure that grow hemp standardized procedure
leading to a defined content of active ingredients of cannabis and consistent quality
produced cannabis. In the second round of the selection procedure is a fundamental
evaluation criterion of the advertised price of the produced cannabis, whose weight in the
the determination of the terms of reference for the assessment of bids must be in the
relation to the partial assessment criteria at least 75%. In procurement
conditions may be limited to a maximum number of persons who may be
granted a license. The State Institute for drug control license grants
None of the candidates if the price offered, plus the implied
costs under section 24b para. the last 2 sentences, will exceed the price of hemp
for medicinal use, available from other countries; for the purpose of market research
does the State Institute for drug control before the second round of the selection
the management of demand in countries that can of cannabis for medicinal use
export, whose parameters are matched to a tender to
the amount of cannabis and the content of active substances.
(3) a Licence is granted after the selection procedure for a period of not more than 5
years of age. In the license of the State Institute for drug control will define the area in which the
the hemp will grow. If it is to end the period of validity of license grant
or is not sufficient if grown cannabis for medicinal use, announces
the new selection process, with a license can be granted.
(4) the person to whom the licence was granted for the cultivation of cannabis for therapeutic
use, is required to
and) to ensure growing and processing suitable for indoors
this purpose,
(b)) to secure the areas where cultivation, harvesting and processing
out against abuse,
(c)) to ensure that all activities in connection with the cultivation, harvest and
processing has been logged,
(d)) at any time allow State Institute for drug control, without the prior
notification to check all of that space for cultivation and
processing, and make him the activity logs and more
the relevant documentation; for the rights and obligations and
of persons shall apply other legislation ^ 15) Likewise,
(e)) to ensure that all plant waste was stored out of the way
laid down in section 10 and the process at its own expense for this person in a manner
laid down in section 14; for vegetable waste shall be considered a hemp
does not conform to the contract documents and the technical conditions laid down pursuant to
paragraph 2,
(f) comply with conditions laid down) referred to in paragraph 2.
(5) in the event that the State Institute for drug control detects a violation of
obligations imposed under paragraph 4 a person which has been granted a license to
the cultivation of cannabis for medicinal use, the licence shall be withdrawn by her.
section 24b
(1) Cannabis grown and harvested in accordance with the conditions laid down
under section 24a of para. 2 is the person to whom the licence was granted shall be obliged to
convert exclusively to the State Institute for drug control. This conversion
provide proof of certificate of quality issued by the control laboratory, whose activity
It is allowed under the law on pharmaceuticals ^ 6). The State Institute for drug control
buy hemp harvested not later than 4 months after the harvest. On the transfer of
contracts shall be concluded written sales contract, the details of which are accurate
specifications for medical use of cannabis harvest, putting his
quantity, quality and the determination of the purchase price, which may not exceed the price
offered in the second round of the selection procedure and must be in the
to what extent were the technical terms of the tendering procedure pursuant to §
paragraph 24A. 2. Hemp is passed formally received.
(2) during transport the harvested hemp must be ensured, that the supply of
It will not be misused in any way and will be delivered exclusively to the operators of a pharmacy
for the preparation of medicinal products. Between the State Institute for drug control
and operator of pharmacies on the transfer of cannabis concludes a written purchase
the contract, for the details of the provisions of paragraph 1 shall apply
Similarly, and hemp is passed also formally received. The purchase price when you
converting hemp to operators of pharmacies is the price subject to the factual
regulate prices under other legislation ^ 16). Its basis is
the purchase price for which cannabis was the trade-off from the person that was
granted a license. The purchase price when converting hemp the pharmacy provider
is a non profit, increased by the costs associated with the takeover of hemp from the person
that the licence was granted, with ensuring transport cannabis and its
protection against abuse during this transport, the costs associated with
storage and the costs associated with the passing of hemp to the operator
the pharmacy.
§ 25
Export and import of poppy concentrate
(1) to the export or import of poppy concentrate requires an export permit
poppy concentrate or licences to poppy concentrate. A request for the issue of an export
permit or import permit shall be made on a form issued by the
The Ministry of health.
(2) an export permit poppy concentrate and an import permit issued by poppy concentrate
The Ministry of health, which is also entitled to authorisation issued
may be withdrawn if there is reason to suspect that there has been a breach of the obligations
arising from this Act or of the decision issued on its basis
or that it is illicit trafficking in accordance with international treaties, which
the Czech Republic is bound. An export permit may be issued for a period of poppy concentrate
It was designed for more exports. An import permit may be issued on poppy concentrate
the time specified in it for more imports. Otherwise, in the issuance and withdrawal of
an export permit and a permit to import poppy concentrate poppy concentrate shall apply
the provisions of Title 4.
TITLE VI OF THE
THE OBLIGATION AND REGISTRATION
section 26
The obligation on the basis of the authorization to the treatment
(1) persons who are entitled to be treated with drugs and
preparations on the basis of the authorization to the treatment are required to transmit
The Ministry of health on forms issued by the Ministry of
health care in writing or in electronic form, signed by a recognized
electronic signature under special legislation. ^ 10a)
and at the end of February) the previous calendar year annual reports on the manufacture,
the cultivation and consumption of addictive substances and preparations, about the disposal of
stores with them and about the status and movement of their stock, if these persons in
the past calendar year shall not treat with these substances, it is sufficient that
the fact, in writing, notify the Ministry of health,
(b)) to the end of April, an estimate of the production, cultivation and importation of the substance abuse and
preparations in the next calendar year; for the products listed in the annex
# 8 Government regulation about the substance list shall indicate only an estimate of the
production; in the case above the initial estimate of production and
the import of these persons are obliged to estimate production and importation without delay
increase; These estimates may be adapted ^ 10b) by the International Bureau for the
Narcotics Control Board ^ 2a),
c) the 15th day of the following month, the monthly returns on imports and
exports of addictive substances and preparations for the previous calendar month, with
exception of those mentioned in annex No. 8 or medicinal products with
containing scheduled substances of category 1.
(2) the Notification obligation also applies to persons handling
addictive substances and preparations referred to in § 5 para. 7. The following persons are
be obliged to supply the Ministry of health the data referred to in paragraph 1.
(3) the persons who are entitled to be treated with drugs and
preparations on the basis of the authorization to the treatment, and persons who for
their activity does not require authorisation for the treatment of addictive
substances and preparations according to § 5 para. 7, are obliged to inform the
the Ministry of health immediately
and of the theft of drugs) and preparations,
(b)) of the special circumstances, such as unusual orders and
transactions with these substances,
(c)) on the basis of his application for further details relating to the
the activities of which are subject to authorisation for treatment.
(4) upon termination of the activities to which the permit is required treatment
or in the case of persons according to § 5 para. 7, is the person that this activity
It carried, required to submit within 30 days from the termination of the activities of the extraordinary
reporting to the extent specified in paragraph 1 (b). and die).
entrepreneurial natural person who has been issued a permit to the treatment,
obligation to submit a special report shall be transferred pursuant to paragraph 1. and) on
the responsible person or its representative and in the case that these persons
cannot meet this obligation, then passes to the administrator of the heritage.
section 27 of the
The obligation of persons operating a pharmacy
(1) a person operating a pharmacy shall be obliged to forward to the State Institute for the
drug control by the end of February, the annual report for the previous calendar year
on the status and movement of stocks of addictive substances listed in Appendix 1 or 5
the Government Decree on the list of substance abuse, as well as products
containing, with the exception of the products listed in annex 8 of Regulation No.
Governments on the list substance abuse. The annual report shall be filed on form
issued by the State Institute for drug control in writing or in electronic
the form signed by a recognized electronic signature under a special
legislation. ^ 10a) if these persons during the past calendar year with
These substances shall not treat, it is sufficient to notify this fact to the
The State Institute for drug control.
(2) upon termination of the activities of the pharmacy ^ 10 c) is a person that this activity
operated, shall submit, within 30 days from the termination of the activities of the State
Institute for drug control special reports within the range specified in the
paragraph 1.
§ 27a
(1) a person operating a pharmacy and drug distributors ^ 10 d) are required to
not later than 10. January calendar year report of the Institute for State
control of veterinary Biologicals and medicaments (hereinafter referred to as "the animal health
the Institute ") subscription of preparations containing addictive substances listed in the annexes to
No 1 and 5 Government regulation about the list of addictive substances, with the exception of
products listed in annex No. 8 on the list of government regulation of addictive
substances, veterinarians for the previous calendar year. The message is
Veterinary Institute on a form served lished.
(2) the animal health Department of the Ministry of health is obliged to forward to the
end of February calendar year report for the previous calendar year
consumption of products containing addictive substances in annexes no. 1
and 5 Government regulation about the list of addictive substances, with the exception of products
referred to in the annex to Decree-Law No 8 of the list of addictive substances,
veterinary surgeons.
section 28
cancelled
section 29
Reporting to the people producing opium poppy or cannabis
People growing opium poppy or cannabis a total area larger than 100 m2
are required to pass the report locally competent Customs Office under the
the place of production, in writing or in electronic form, signed by a recognized
electronic signature under special legislation ^ 10a)
and the end of May)
1. assessment of land sown with poppy seeds or cannabis varieties for harvest in
the calendar year, including the name of the varieties used ^ 10 g), numbers
parcel number, name, and cadastral territory ^ 10 h), or identification
soil block numbers, or the part of the soil block land parcel ^ 10i)
2. an estimate of the acreage of the land on which it will be grown opium poppy or cannabis in
the next calendar year,
(b)) in the vegetation and harvest or during the disposal of harvested
data on the area of poppy concentrate land and how the destruction of opium poppy,
poppy concentrate left on land or harvested or hemp, including the name of
registered varieties used ^ 10 g), parcel number, name, and numbers
cadastral territory ^ 10 h) or identification number of the soil block
where applicable, a part of the soil block, evidence of soil ^ 10i), no later than 5
days before performing their disposal; If the person cultivating opium poppy
reverse does not remove the makovinu coming from the treated seeds, passes
obligation to transmit reports during the disposal of poppy concentrate on a person who
cleaning poppy seeds,
(c)) to the end of December of the calendar year
1. assessment of land that have been sown with poppy seed or hemp varieties, assessment
the land from which the harvested opium poppy or cannabis, including the name of
used the registered variety, ^ 10 g) parcel number, name, and numbers
cadastral territory, ^ 10 h) or identification number of the soil block
Alternatively, the part of the soil block land parcel ^ 10i)
2. the quantities harvested poppy concentrate, hemp, poppy seed and seed
hemp,
3. the weight, the year of harvesting poppy concentrate or hemp sold or otherwise
the converted and new identification of the acquirer.
section 30
The obligation in the export and import of poppy concentrate
Anyone who has carried out the export or import of poppy concentrate, it shall transmit the
The Ministry of health to the fifteenth day of the first month
calendar quarter, quarterly reports on the export or import of poppy concentrate
in the previous quarter. Quarterly reports shall be submitted on the form
issued by the Ministry of health in writing or in electronic form
signed by a recognized electronic signature under a special legal
^ 10a) of the code.
section 31
Form of reports
(1) a Report shall be made on forms issued by the Ministry of
health care, except for the information referred to in section 27, which serves to
Forms issued by the State Institute for drug control, with the exception of
information according to § 27a, which shall be made on forms issued by the
The animal health Institute, and except for the information referred to in section 29, in writing
or in electronic form, signed by a recognized electronic signature
under special legislation. ^ 10a)
(2) the Ministry of finance and the Ministry of agriculture shall issue a decree
model of form for the reporting of people producing opium poppy or cannabis (section 29)
and how to fill in and the management of the said form.
§ 32
Record keeping and documentation
(1) for the treatment of addictive substances and preparations, as well as their
imports and exports are leading the way ^ 10j) evidence. The registration of
they are obliged to keep persons who carry out the activities for which it is necessary to
the authorization to the treatment of the export permit or import permit,
persons who operate a health facility, the person operating the
device providing residential social services, persons who provide
veterinary care, and the persons referred to in § 5 para. 6 and in § 5 para. 7.
(2) the details and content of the evidence and documentation, their types, forms of
management of documentation and the method of storage and verification provides
The Ministry of Health decree.
§ 33
Retention of documentation
(1) documents relating to the treatment of addictive substances and
products and their exports and imports must be kept for a period of 5 years.
(2) details of how and when the retention of documentation down
The Ministry of Health decree.
TITLE VII
REVIEW
§ 34
Inspectors
(1) the checking of compliance with the obligations arising from this Act and of the
decision issued on its basis shall carry out
and) authorized employees
1. the Ministry of health,
2. The State Institute for drug control in matters relating to pharmacies and
treatment with cannabis for medicinal use,
3. regions of inclusion in the regional office, if it is not about control of pharmacies, and
Furthermore, in matters relating to the inspection referred to in section 13 and 14,
4. The animal health Institute,
(b)) members
1. the police of the Czech Republic,
2. the customs administration of the Czech Republic in matters relating to poppy cultivation
linseed and hemp and in matters relating to compliance with the obligations arising from article 11,
(hereinafter referred to as "inspectors").
(2) inspectors are authorized to make unannounced inspections in advance.
(3) an inspector is required to demonstrate the audit work with the card
issued by one of the authorities referred to in paragraph 1.
(4) an inspector in the performance of the inspection work shall be entitled to
and land) to enter into objects and rooms,
(b) require an explanation of the facts) and the production of documents and
documents,
(c)) to take copies of papers and documents and statements from them, and if so
do so, and at the same time it is necessary to perform the scan, remove and
documents,
(d)) to the extent strictly necessary for the implementation of control samples.
(5) if requested in writing, the person shall provide the controlled inspection authority
samples taken for compensation of production or acquisition costs.
(6) the inspector shall consult with the controlled person of the shortcomings detected in the
control and the method and time limit for their removal. On the progress and outcome of the
the inspection, the inspector shall draw up a protocol.
(7) the Controlled persons are obliged to suffer the control and provide
the assistance needed to implement it.
(8) For the purposes of monitoring the cultivation of opium poppy or cannabis provide
cadastral offices customs data from the land registry free of charge.
§ 35
Checking on receipt of the
Everyone is obliged to when accepting the addictive substances and preparations examined,
If their quantity and type corresponds to the accompanying documents, and
significant irregularities immediately notify the police of the Czech Republic and
The Ministry of health.
TITLE VIII
ADMINISTRATIVE OFFENCES
section 36
Administrative offences
(1) a legal entity or individual entrepreneur is committed by the administrative
tort by
and) contrary to section 4 pursues an activity that requires a permit to
treatment, without this authorisation,
b) contrary to section 5 (3). 8 do not notify the Ministry of health change
the data referred to in the list,
c) contrary to section 8 (2). 2 manufactures addictive substances or preparations of
maximum available refund volume laid down in the authorization to the treatment,
(d)) in the application for the authorization to the treatment administered pursuant to section 8 (2). 6 shall be
incorrect or incomplete data,
e) contrary to section 8 (2). 7 absence of the Ministry of health in writing
an application for a new permit for treatment no later than 6 weeks prior to the
the expiry date of an existing authorisation for treatment,
f) contrary to section 8 (2). 8 do not communicate in writing to the Ministry of health
change of information contained in the request for authorization to the treatment,
g) has requested the release of the new permits for treatment in the case of some of the
changes to the data referred to in the request for authorization to the treatment provided for under section 8
paragraph. 9,
h) contrary to section 8 (2). 11 has not notified of termination of the activity to which it
the authorization to the treatment,
I) contrary to section 8 (2). 13 Department of health does not return void
the authorization to the treatment within 14 days from the date of acquisition of legal power of the new
the authorization to the treatment,
j) in violation of § 9 para. 9 to notify in writing the Ministry of health
appointment of a representative of the responsible person or termination of its functions,
k) in violation of § 9 para. 10 does not appoint a responsible person in the
the prescribed period or has requested the Ministry of health about the change
the authorization to the treatment,
l) contrary to section 10 of the stores of addictive substances and preparations, as well as
the equipment for their production or cultivation,
m) contrary to section 11 transports the addictive substances listed in the annexes 1,
2, 3 or 5 Government regulation about the list of addictive substances and preparations is
tagged,
n) contrary to section 12 of the passes or sells addictive substances and preparations or
other rights associated with addictive substances and preparations,
about) as the person referred to in § 5 para. 2 (a). a) or b) fails
debased forms of the recipes or requisitions with a blue stripe municipal
Office of the municipality with extended competence pursuant to § 13 para. 6,
p) as a person who no longer meets the conditions laid down in § 5 para. 2
(a). and) or (b)), does not relinquish unused or degraded forms
recipes or requisitions with a blue stripe within 5 days of the village Municipal Council
extended jurisdiction pursuant to § 13 para. 7,
q) contrary to § 14 para. 1 does not make a disposal of unusable
addictive substances and preparations or wastes containing,
r) contrary to section 15 (b). and) places the addictive substances and preparations in
customs warehouses, free zones or free warehouses
warehouses,
with the breach of any of the prohibitions), pursuant to section 15 (b). (b)),
t) contrary to section 20 (2). 1 take the addictive substances or preparations without
an export permit, in addition to growing cannabis for medicinal use, to
which the license
u) contrary to section 21 para. 1 takes the addictive substances or preparations without
import permit,
in the request) an export or import permit, in accordance with section 22 paragraph 1. 2
incorrect or incomplete information shall,
w) does not return the Ministry of health of the export or import authorisation
According to section 22 para. 3,
x) violates the ban to cultivate cannabis plant species or variety (genus
Cannabis), which can contain no more than 0.3% of the substances from the Group of
tetrahydrokanabinolů, pursuant to § 24 para. 1 (b). a), or
s) violates the ban to cultivate opium poppy varieties, which may, in the dry matter of the
capsules contain more than 0.8% of morphine, according to § 24 para. 1 (b). (c)).
(2) a legal entity or individual entrepreneur is committed by the administrative
tort by
and growing as a person), opium poppy or the person handling or
to notify immediately the police holding the makovinu of the Czech Republic
the circumstances pursuant to § 24 para. 2,
b) contrary to section 24 para. 3 inactivate or reflects the makovinu poppy
field vyprodukovanou on the territory of the Czech Republic,
c) contrary to section 25 para. 1 ride or makovinu without the import export
or export permit
(d)) in the application for an export permit or a permit to import poppy concentrate
poppy concentrate according to § 25 para. 1 indicate incorrect or incomplete data,
e) as the person who is authorised to deal with addictive substances and
preparations on the basis of the authorization to the treatment, fail to comply with any of the
reporting obligations pursuant to section 26 paragraph 1. 1 or 3, or in the report shall be
incorrect or incomplete data,
(f)) as a person, that its action does not require a licence to
treatment of addictive substances and preparations according to § 5 para. 7, fails to comply with
one of the reporting obligations in accordance with § 26 para. 2,
g) contrary to section 30 does not pass the Ministry of health to the 15th
the first day of the month following the calendar quarter quarterly
reports on the export or import of poppy concentrate in the previous quarter, or in
reports indicate incorrect or incomplete data,
(h) fails to fulfil any of the obligations) under § 32 para. 1 or § 33 para. 1,
I) fails to comply with the control or the obligation of notification under section 35, or
(j)) does not use the names of addictive substances and preparations according to § 42.
(3) a legal entity or individual entrepreneur, which provides
Pharmacy, health services, committing an administrative offense further by
and) contrary to section 27 para. 1 does not pass to the State Institute for drug control
by the end of February, the annual report for the previous calendar year and status
movement of stocks of addictive substances listed in Appendix 1 or 5 of regulation
Governments on the list of addictive substances, including products containing,
exception of those mentioned in annex No. 8 on the list of government regulations
substance abuse,
b) contrary to section 27 para. 1 shall indicate in its annual reports on the status and movement of
stocks of addictive substances listed in Appendix 1 or 5 of regulation of the Government of
list of addictive substances, including products containing them, with the exception of
products listed in annex No. 8 on the list of government regulation of addictive
substances, for the previous calendar year of incorrect or incomplete information, or
c) in contravention of section 27 para. 2 upon termination of the activities of the pharmacy does not pass
The State Institute for drug control of emergency status report and movement
stocks of addictive substances listed in Appendix 1 or 5 of regulation of the Government of
list of addictive substances, including products containing them, with the exception of
products listed in annex No. 8 on the list of government regulation of addictive
substances, or in the report indicate incorrect or incomplete data.
(4) a legal entity or individual entrepreneur, which provides
Pharmacy, health services or distributes pharmaceuticals, is guilty of an
the administrative offense further by
and) contrary to section 27a para. 1 does not report to a 10. January of the calendar year
Veterinary Institute of preparations containing addictive substances collection
referred to in annexes 1 and 5 Government regulation about the list of addictive substances,
with the exception of those listed in annex No. 8 on the list of government regulations
substance abuse, veterinarians for the previous calendar year, or
b) contrary to section 27a para. 1 shall indicate in the report about the subscription products
containing addictive substances referred to in annexes 1 and 5 of the regulation of the Government
about the list of addictive substances, with the exception of the products listed in annex No.
8 Government regulation about the list of substance abuse, for veterinarians
the previous calendar year of incorrect or incomplete information.
(5) a legal entity or individual entrepreneur, which cultivates opium poppy
or hemp on a total area larger than 100 square meters, is guilty of an administrative
tort by
and) contrary to section 29 does not fulfil the obligation, or
(b)) provide inaccurate or incomplete information in the reports referred to in section 29.
(6) a legal entity or individual entrepreneur, which was awarded to the
the licence for the cultivation of cannabis for medicinal use, is guilty of an administrative
tort by breach of an obligation under section 24a of para. 4 (b). and), (b)),
(c)), d), (e)), or (f)) or under section 24b para. 1.
§ 37
Penalties
(1) for the administrative offence under § 36 odst. 1 shall be imposed to
and 500 000 CZK), in the case of an administrative offence referred to in subparagraph (b)), (c)), e) to (h)),
j) to q)), x) or y),
(b)) 1 000 000 CZK in the case of an administrative offence referred to in subparagraph (d)), i, t)))
or w),
(c) Eur 10 000 000), in the case of an administrative offence under (a)), r) or s).
(2) an administrative offence under § 36 odst. 2, fined the 500 000 CZK.
(3) for the administrative offence under § 36 odst. 3, fined the
and 500 000 CZK), in the case of an administrative offence under (a)), and (c)),
(b)) 1 000 000 CZK in the case of an administrative offence referred to in subparagraph (b)).
(4) for the administrative offence under § 36 odst. 4, fined the
and 500 000 CZK), in the case of an administrative offence under (a)),
(b)) 1 000 000 CZK in the case of an administrative offence referred to in subparagraph (b)).
(5) an administrative offence under § 36 odst. 5, fined the
and 500 000 CZK), in the case of an administrative offence referred to in subparagraph (b)),
(b)) 1 000 000 CZK in the case of an administrative offence under (a)).
(6) for the administrative offence under § 36 odst. 6, imposed to 1 000 000
CZK.
§ 38
Forfeiture of things
For the administrative offence under section 36, you can save the confiscation of substance abuse and
products, equipment, and materials needed for their manufacture or
growing, if the perpetrator belongs to an administrative offense and
and) were for committing an administrative offense intended,
(b)) have been used to an administrative offence,
(c) committing an administrative offense) were obtained, or
(d)) they were acquired as a matter of administrative tort obtained.
§ 38a
Prevents things
cancelled
If no saved confiscation referred to in § 38, you can decide that the
such a thing works, if the offender belongs, which can't be for administrative
offence to prosecute, or does not belong to the perpetrator of the administrative offense or his
does not belong in full, and if required by the safety of persons, property or other
the general interest.
§ 39
Misdemeanors
(1) a natural person cultivating opium poppy or cannabis a total area larger
than 100 m2 is guilty of an offence by
and fails to comply with the notification obligations of) section 29,
(b)) provide inaccurate or incomplete information in the reports referred to in section 29.
(2) for the offense referred to in paragraph 1 (b). and you can impose a fine to a) 100 000
And for the offense referred to in paragraph 1 (b). (b) impose a fine to a can) 200
000. You can control the page block for the offense referred to in paragraph 1 save
a fine of up to CZK 5,000.
section 40
Common provisions
(1) a legal person for an administrative offence is not liable if he proves that
made every effort, that it was possible to require that the infringement of the
a legal obligation is prevented.
(2) in determining the amount of the fine on a legal person shall take account of the seriousness of the
the administrative offense, in particular, the way a criminal offence and its consequences, and
the circumstances under which it was committed.
(3) the liability of a legal person for an administrative offense shall cease, if the
competent administrative authority about him has commenced proceedings in the 5 years from the day on which the
aware of it, but not later than 10 years from the date on which the administrative
offence has been committed.
(4) administrative offenses under § 36 odst. 1 and 2, with the exception of the administrative
offences under § 36 para. 1 (b). l) and q), committed in the health
facilities including a pharmacy, according to § 36 odst. 1 (b). m), o), p, r)), x) and
s) and in accordance with § 36 odst. 2 (a). a), b), (h) and (i))), in the first instance
discusses the Ministry of health.
(5) administrative offenses under § 36 odst. 1 (b). l), o), p) and (q)) and under section
paragraph 36. 2 (a). h) and (i)), committed in a medical facility outside of the
Pharmacy, in the first instance dealt with regional office.
(6) administrative offenses under § 36 odst. 1 (b). l) and (q)) and pursuant to § 36 odst.
2 (a). h) and (i)), committed in a pharmacy, and in accordance with § 36 odst. 3 (b). a), (b))
and (c)) and in accordance with § 36 odst. 6 in the first instance dealt with the State Institute of
drug control.
(7) administrative offenses under § 36 odst. 1 (b). m), r), x and y)), section 36
paragraph. 2 (a). a) and b) and in accordance with § 36 odst. 5 (b). a) and b) and misdemeanors
pursuant to § 39 para. 1 (b). a) and b) in the first instance hearing of the customs
administration of the Czech Republic.
(8) for administrative offences pursuant to § 36 odst. 4 (b). a) and b) in the first instance
discusses the Health Institute.
(9) The liability for the acts, which took place in the business
person ^ 10 p) or in direct connection with it shall be subject to the provisions of
This law on liability of legal persons and sanctions.
(10) the Fines collected and enforced by the authority that is saved. The decision on the
the imposition of fines can be done within 5 years after the expiry of the period specified for their
payment.
(11) income from fines imposed by the Ministry of health, the customs
authorities, the State Institute for drug control, the Veterinary Institute is
State budget revenue. Income from the fines imposed on the regional authority is
the income of the region.
TITLE IX OF THE
PROVISIONS COMMON, TRANSITIONAL AND FINAL
§ 41
The relationship of the special legislation
Provisions of specific laws relating to substance abuse
and preparations remain intact. ^ 11)
section 41a
cancelled
§ 42
In all official documents, commercial documents and forms
must be used in the names of the substance according to the annexes to the regulation of the Government of
list of substance abuse. In the case of proprietary medicinal products
^ 11b products) with their names indicate only the registered name.
§ 43
Interaction of State bodies
(1) the ministries and other central administrative authorities shall cooperate with the
The Ministry of health to the extent arising from their scope
in the preparation of documentation for
and international organizations about the treatment) with addictive substances and preparations,
(b)) new proposals for inclusion of substances between the addictive substances to the annexes
the Government Decree on the list of substance abuse.
(2) the regional offices shall be communicated to the Ministry of health to the end of February for the
previous calendar year data on addictive substances and preparations
destroyed in accordance with § 14 para. 3.
(3) the authorities of the customs administrations of the United States are required to communicate to the police
United States individual reports people producing opium poppy or
hemp in accordance with section 29 as follows:
and information according to § 29) (a). and) to 10. June of the calendar
of the year,
(b) the information referred to in section 29) (a). (b)).
(4) the Customs authorities are obliged to transmit to the Directorate-General of customs
individual reports of people producing opium poppy or cannabis pursuant to § 29
as follows:
and information according to § 29) (a). and) to 10. June of the calendar
of the year,
(b) the information referred to in section 29) (a). (b)) shall, without delay,
(c) the information referred to in section 29) (a). (c)) until 31 December 2006. March for the previous calendar
year.
(5) the Directorate-General of customs says the Ministry of agriculture data
and according to section 29 (a)). 20.) June of the calendar year,
(b) under section 29 (a)). (b)) to 31. March for the previous calendar year,
(c) according to section 29 (a)). (c)) to 30. April for the previous calendar year
Forms issued by the Ministry of agriculture.
(6) the Directorate-General of customs says Ministry of health data
and according to section 29 (a)). 20.) June of the calendar year,
(b) under section 29 (a)). (c)) to 30. April for the previous calendar year
Forms issued by the Ministry of health.
(7) the State Institute for drug control, and the Institute for State control
Veterinary Biologicals and medicaments
and shall inform the Ministry of health on an ongoing basis) of
1. received applications for registration of medicinal products containing
addictive substances,
2. breach of the obligations arising from this Act and the decision of the
issued on its basis,
(b) be transmitted to the Ministry of health on an ongoing basis) copies
final marketing authorisation for medicinal products containing
addictive substances,
(c)) shall transmit to the Ministry of health annual report pursuant to section 26 paragraph 1.
1 (b). and)
(d) inform the competent continuously) Regional Office for breach of duties
arising from this Act and the decisions taken on this
basis.
(8) the State Institute for drug control
and) perform the tasks for the State Agency for cannabis for medicinal use ^ 2a),
(b)) shall inform the Ministry of health on an ongoing basis and the police of the Czech
of the Republic of
1. the measures taken to secure the cultivation and processing of hemp for
medicinal use
2. licences granted for the cultivation of cannabis for medicinal use,
3. the breach of the obligations arising from this Act and decisions
issued on its basis,
(c)) shall carry out the obligation of notification to the Ministry of health under section
43A paragraph. 4 (b). (f)).
(d)) shall inform the Ministry of health about the checks carried out in
pharmacies and instituted administrative proceedings conducted on the basis of
violation of obligations established by this Act, to 30. April, 31.
July, 30. October and 31. January for the previous calendar quarter.
§ 43a
The scope of the public authorities
(1) the Ministry of health outside of the activities provided for by this Act
Furthermore, in the field of addictive substances and preparations,
and) decide on appeals against the decisions of the Regional Office
and the State Institute for drug control in the cases referred to in § 40 paragraph 2.
5 and 6,
(b)) provides to the International Narcotics Control Board
1. quarterly data relating to the import and export of narcotic drugs, ^ 11 c)
psychotropic substances ^ 11 d) of the annex to Decree-Law No. 5 on the list of
addictive substances and preparations containing these substances for the past 3
of the month
2. once a year to 30. June figures relating to the production, manufacture,
cultivation, consumption, stocks and seizures of narcotic drugs and quantities
preparations containing these substances for the previous calendar year, ^ 11e)
3. once a year to 30. June data on production, stocks,
imports and exports of psychotropic substances and of products containing these
substances for the previous calendar year, ^ 11f)
4. by 30 June. June estimate of necessary drugs, ^ 11 g) psychotropic
^ 11 h) substances and preparations containing these substances on the following
calendar year and their Add-ons ^ 11i) during the calendar year,
(c) cooperate with the competent authorities) State of the importer and the exporter.
(2) the police of the Czech Republic
and the Ministry of health about) informs all important
the facts necessary for their decisions under this Act,
in particular, about the theft of addictive substances and preparations and their attempts
theft,
(b) may at any time) is a remotely through a specified contact
the workplace in case of detection of cannabis or cannabis-containing product for
person to object to the request to the registry for medicinal products with restrictions
served according to the law on pharmaceuticals ^ 6), whether that person be conducted between
persons who have been issued individually prepared medicinal product with the
content of cannabis for medicinal use; such request register
without delay and free of charge, will match the desired value; in the case that it is
This person conducted between persons who have been issued individually
prepared a medicine containing cannabis for medicinal use,
Furthermore, the registry free of charge shall notify the date of issue and the total issued amount
individually prepared medicinal product containing cannabis for
therapeutic use.
(3) the authorities of the customs administration of the Czech Republic
and) indicate through the General Directorate of customs, the Ministry of
health of all relevant facts necessary for its
decisions under this Act, in particular on the ^ 11j) cases
ensure ^ 11o) addictive substances and preparations,
(b)) to provide, through the General Directorate of customs information about
imports or exports of addictive substances and products, the Ministry of
the health sector.
(4) the State Institute for drug control
and) grants the licence to grow hemp for medical use; This license
contains the entry area, parcel number, name, dimensions,
the name of the registered varieties used and the identification number of the soil
a block, or a part of the soil block as evidence of land use,
(b) consistency) checks the cultivation of cannabis for medicinal use, the terms of the
set out under section 24a of para. 2 and the consistency of processing and storage of hemp
for therapeutic use with the rules of good manufacturing practice and checks its
security against theft and misuse in the context of the protection of public health,
(c) the purchase of all crops produced) and harvested cannabis for
medicinal use, whose quality is accompanied by the certificate provided for in section 24b of paragraph 1.
1, no later than 4 months after the harvest,
d) exported cannabis for medicinal use, under the conditions laid down in this
by law,
e) ensures a safe storage, transport and distribution of cannabis for
therapeutic use, including by means of other persons on the basis of the Treaty,
f) announces the Ministry of health in writing or in electronic
the form of an advanced electronic signature signed by another legal
^ Regulation 10a)
1. by the end of February for the previous calendar year, the annual report on the quantities of
produced, processed, zneškodněného, adopted, issued by cannabis
for therapeutic use, including export, trade, health and movement of its inventory,
2. by the end of April, an estimate of the production of cannabis for medicinal use on
the following calendar year; that estimate may be adapted ^ 10b)
The International Bureau for control of narcotic substances ^ 2a),
3. the 15th day of the next calendar month monthly reports
on the export of cannabis for medicinal use, for the previous calendar month.
§ 44
Common provisions
Appeal lodged against the decision on the withdrawal of authorisation for the treatment of
the withdrawal of an export permit, import permit, on the withdrawal of the withdrawal
an export permit poppy concentrate and the withdrawal of licences to poppy concentrate has
suspensory effect.
§ 44a
For the regional authority or municipality of the village with
extended jurisdiction under this Act are transferred
the scope of the.
section 44b
Forms forms
Forms forms referred to in § 5 para. 7, § 8 para. 6 and 11, section 9
paragraph. 10, § 22 para. 2, § 25 para. 2, § 26 para. 1, § 27 para. 1, § 30,
§ 31 para. 1 and § 43 para. 6, including the annexes, which are an integral
part of the Ministry of health shall lay down by Decree, and also publish
manner allowing remote access.
§ 44 c
Powers of execution
(1) the Government shall determine by regulation
and) list
1. the narcotic drugs listed in Schedule I in accordance with the single Convention on
narcotic drugs and
2. other drugs, which is due to the extent of their
abuse or because they directly or indirectly jeopardize the health,
necessary to provide treatment on the basis of the authorization to the treatment, or is
for this reason, you must ensure that the medicinal products containing these
the substances were emitted in the pharmacy only on a prescription or requisition marked
blue stripe, oriented from bottom left to the top right corner,
(b)) list
1. the narcotic substances included in List II of the single Convention on
narcotic drugs and
2. other stupefying substances for which there is, because of the extent of their
abuse or because they directly or indirectly jeopardize the health,
must ensure that medicinal products containing these substances are
issued in a pharmacy on prescription or requisition without marking the blue line
(c)) list
1. the narcotic substances included in list IV in accordance with the single Convention on
narcotic drugs and
2. other stupefying substances for which there is, because of the extent of their
abuse or because they directly or indirectly jeopardize the health,
necessary to ensure that substances and preparations containing these other narcotic
substances have been used only to a limited research, scientific and very
limited therapeutic purposes defined in the authorization to the treatment,
(d)) list
1. psychotropic substances included in list I of the Convention
psychotropic substances and
2. other psychotropic substances, for which, because of the extent of their
abuse or because they directly or indirectly jeopardize the health,
necessary to ensure that substances and preparations containing these additional
psychotropic drugs were used only to limited research, scientific
and very limited therapeutic purposes defined in the authorization to the treatment,
e) list
1. psychotropic substances included in list II in accordance with the Convention on the
psychotropic substances and
2. other psychotropic substances, which is due to the extent of their
abuse or because they directly or indirectly jeopardize the health,
necessary to provide treatment on the basis of the authorization to the treatment, or is
for this reason, you must ensure that the medicinal products containing these
the substances were emitted in the pharmacy only on a prescription or requisition marked
blue stripe, oriented from bottom left to the top right corner,
f) the list of psychotropic substances included in the list (III) under the Convention on
psychotropic substances,
g) list
1. psychotropic substances included in the list (IV) under the Convention on
psychotropic substances and
2. other psychotropic substances, for which, because of the extent of their
abuse or because they directly or indirectly jeopardize the health,
must ensure that medicinal products containing these substances are
issued in a pharmacy on prescription or requisition without marking the blue line, and
h) list of the included in the list according to the single Convention on
narcotic drugs.
(2) the Government shall state the list by
and paragraph 1 (a)). and) in annex 1 to the regulation referred to in paragraph 1,
(b) paragraph 1 (a)). (b)) in annex 2 to the regulation referred to in paragraph 1,
(c) paragraph 1 (a)). (c)) in annex No. 3 to the regulation referred to in paragraph 1,
(d) paragraph 1 (a)). d) in annex 4 to the regulation referred to in paragraph 1,
e) to paragraph 1. e) in the annex 5 to the regulation referred to in paragraph 1,
f) to paragraph 1. (f)) in annex No 6 to the regulation referred to in paragraph 1,
(g) paragraph 1 (a)). g) in Appendix 7 to the regulation referred to in paragraph 1 and
(h)) to paragraph 1. h) in annex No. 8 to the regulation referred to in paragraph 1.
(3) the Ministry of agriculture to implement section 24 establishes by decree a list of
opium poppy varieties that meet the condition of maximum 0.8% content
morphine in the dry matter of the capsules, and the method of disposal of poppy concentrate.
§ 45
Transitional provisions
(1) the authorization to the treatment of drugs and psychotropic substances
or preparations and a special permit for export or import of narcotic drugs
or psychotropic substances or products issued under the existing
the regulations shall be construed as authorization to the treatment, an export permit, import
the authorisation, the authorisation to export or authorization to import poppy concentrate poppy concentrate
under this Act for a period of 6 months from the effective date of this Act.
(2) the procedure for the issue of permits to the treatment with drugs and
psychotropic substances or preparations and for the issue of a special permit to
export or import of narcotic drugs or psychotropic substances, or
According to present regulations, products ^ 13) which has not been lawfully
terminated the effective date of this Act, shall stop.
(3) manufacturers of auxiliary substances of category 2 and 3 according to the directly applicable
Regulation of the European communities are required to register with the
The Ministry of health (section 16) within 3 months from the effectiveness of this
the law.
PART TWO
cancelled
§ 46
cancelled
PART THREE
§ 47
Amendment to the Trade Licensing Act
Act No. 455/1991 Coll., on trades (Trade Act),
as amended by Act No. 234/1992 Coll., Act No. 586/1992 Coll., Act No.
273/1993 Coll., Act No. 303/1993 Coll., Act No. 38/1994 Coll., Act No.
42/1994 Coll., Act No. 133/1994 Coll., Act No. 200/1994 Coll., Act No.
237/1995 Coll., Act No. 283/1995 Coll., Act No. 94/1996 Coll., Act No.
95/1996 Coll., Act No. 147/1996 Coll., Act No. 19/1997 Coll., Act No.
49/1997 Coll., Act No. 61/1997 Coll., Act No. 79/1997 Coll., Act No.
217/1997 Coll., Act No. 277/1997 Coll., Act No. 15/1998 Coll., Act No.
83/1998 Coll. and Act No. 157/1998 Coll., is amended as follows:
In section 3, paragraph 3. 3 the letter k) including footnote No. 21):
"the treatment of addictive substances), preparations containing them, and with
some of the substances used in the manufacture or processing of addictive substances
by a special Act, ^ 21)
21) Act No. 167/1998 Coll., on addictive substances and amending certain
other laws. ".
PART FOUR
cancelled
§ 48
cancelled
PART FIVE
§ 49
Amendment of the Act on administrative fees
Act No. 368/1992 Coll., on administrative fees, as amended by Act No.
10/1993 Coll., Act No. 72/1994 Coll., Act No. 85/1994 Coll., Act No.
273/1994 Coll., Act No. 36/1995 Coll., Act No. 118/1995 Coll., Act No.
160/1995 Coll., Act No. 301/1995 Coll., Act No. 151/1997 Coll., Act No.
305/1997 Coll. and Act No. 157/1998 Coll., is amended as follows:
In Tariff administrative fees for item 131a, 131b entry is inserted
to read as follows:
"Entry 131b
and treatment) drugs, psychotropic
substances, preparations and products containing certain substances is
used in the manufacture or processing narcotic drugs or
psychotropic substances Czk 3000.0-
(b)) a permit to import or export of narcotic drugs, psychotropic
substances, preparations containing them, some of the substances used
in the manufacture or processing of narcotic drugs or psychotropic substances
and for export of excipients, $ 500.0-
(c)) the authorization to export or import-$ 500.0-poppy concentrate ".
PART SIX
Cancelled
§ 50
cancelled
PART SEVEN
§ 51
The effectiveness of the
This Act shall take effect on 1 January 2000. on 1 January 1999.
Zeman in r.
Havel, v. r.
Tošovský in r.
Č. 1
cancelled
Č. 2
cancelled
Č. 3
cancelled
Č. 4
cancelled
Č. 5
cancelled
Č. 6
cancelled
Č. 7
cancelled
Č. 8
cancelled
Č. 9
cancelled
Č. 10
cancelled
Č. 11
cancelled
Selected provisions of the novel
Article. (II) Act No. 362/2004 Sb.
Transitional provisions
1. Initiated proceedings for the registration of which has not been lawfully terminated to
date of entry into force of this law shall be completed in accordance with existing
legislation.
2. Launched proceedings for penalties, which have not been lawfully terminated on the date of
entry into force of this law shall be completed in accordance with the existing laws,
regulations.
3. The obligation referred to in section 29 will meet the person for the first time in 2005.
4. the responsible person appointed before the date of entry into force of this Act
It is considered a responsible person under this Act.
Article II of law No 74/2006 Sb.
Transitional provision
The authorization to the treatment of addictive substances, and precursors
issued by the Ministry of health under Act No. 167/1998 Coll., on
the version in force until the date of entry into force of this Act, shall remain in
valid until the expiry of the period for which it was issued.
Article. (II) Act No. 273/Sb.
Transitional provision
The last calendar year in which you can grow and harvest varieties
opium poppy (Papaver somniferum l.) that can in the dry matter of the capsules
contain more than 0.8% of morphine is the calendar year following the
the year in which this law came into effect, with the exception of cultivation and
harvest varieties of opium poppy (Papaver somniferum l.) for research and
experimental purposes, for the cultivation of new varieties of plants, and for maintaining the
genetic diversity of plants by scientific and research institutions.
1) European Parliament and Council Regulation (EC) No 273/2004 of 11 March.
February 2004 on drug precursors, as amended.
2A) Decree No. 47/1965 Coll., on the single Convention on narcotic drugs, in
the texts of communication No. 458/1991, a Protocol on amendments to the single Convention on
narcotic drugs, 1961.
2 c) the Convention on psychotropic substances, the renowned under no 62/1989 Coll.
2D) Article. 1 (1). 2 of Council Regulation (EEC) No 3677/90.
2E) Law No 378/2007 Coll., on pharmaceuticals and on changes of some
related laws (law on medicinal products), as amended.
3) Act No. 125/1997 Coll., on waste, as amended.
4) § 25 para. 1 (b). and) of Act No. 87/1987 Coll. on veterinary care.
5 paragraph 33 et seq.). Act No. 79/1997 Coll.
5A) section 39 of Act No. 79/1997 Coll.
5B) § 107 para. 2 of Act No. 13/1993 Coll., as amended.
5 d) section 187, 187a, 188 and 188 a of Act No. 140/1961 Coll., the criminal act.
5E) Act No. 157/1998 Coll., on chemical substances and chemical
preparations and amending certain other acts, as amended
regulations.
5F) Act No. 266/1994 Coll., on criminal records, as amended
regulations.
6) Law No. 378/2007 Coll., on pharmaceuticals and on changes of some
related laws (law on medicinal products), as amended.
6a) § 39 para. 3 of the law No 378/2007 Sb.
6B) Decree No. 351/1997 Coll., laying down the method of prescribing
medicinal products, the particulars of prescriptions and their rules
the use of the.
6 c) section 50 of the Act No. 79/1997 Coll.
7) § 162, 162a and 220 of the Act No. 13/1993 Coll. as amended by Act No. 113/1997
SB.
7A) Article. 6 (1). 2 of Council Regulation (EEC) No 3677/90, as amended by regulation
Council Regulation (EC) no 988/2002.
Article 7 c). 1 (1). 1 of Commission Regulation (EEC) no 3769/92 of 21 December. December
1992 implementing and amending Council Regulation (EEC) No 3677/90, as amended by
Commission Regulation (EC) No 1232/2002.
8A) Decree No. 47/1965 Coll., as amended by communication No. 458/1991 Coll., Convention on the
psychotropic substances known for under no 62/1989 Coll.
8B) Council Regulation (EC) No 111/2005 of 22 December 2004. December 2004
laying down rules for the monitoring of trade in drug precursors between the
Community and third countries.
Commission Regulation (EC) No 1277/2005 of 27 June. July 2005
detailed rules for the regulation of the European Parliament and of the Council (EC)
No 273/2004 on drug precursors and for Council Regulation (EC) No 111/2005,
laying down rules for the monitoring of trade in drug precursors between the
Community and third countries.
9) § 309 to 311 of the Act No. 13/1993 Coll. as amended by Act No. 113/1997.
10) Act No. 283/1991 Coll., on the police of the Czech Republic, as amended by
amended.
10A) Act No 227/2000 Coll. on electronic signature and amending certain
other laws (the law on electronic signature), as amended
regulations. Government Regulation No. 304/2001 Coll., implementing Act No.
227/2000 Coll. on electronic signature and amending certain other
laws (the law on electronic signature).
10B) Article. 19 para. 2 and article. 21, art. 3 Decree No. 47/1965 Coll.
10 c) Law No. 160/1992 Coll., on health care in non-State
medical devices, as amended.
10 d) section 4 (4). 3 of Act No. 79/1997 Coll.
10 g) Act No. 218/2003 Coll., on marketing of seeds and plants
cultivated plants and amending some laws (law on the circulation of the seed and
seed), as amended.
10 h) Act No. 344/1992 Coll., on the land register of the Czech Republic
(Act), as amended.
10i) § 3a of Act No. 252/1997 Coll., on agriculture, as amended by Act No.
128/2003 Coll., Act No. 441/2005 Coll. and Act No. 291/2009 Sb.
10j) Decree No. 304/1998 Coll., as amended by Decree No 143/2000 Sb.
10n) Article. 2 (2). 4 Council Regulation (EEC) No 3677/90, as amended by regulation
Council Regulation (EEC) no 900/92.
10o) article 8 of Council Regulation (EEC) No 3677/90.
10 p) § 2 of the commercial code.
11) Eg. Act No. 79/1997 Coll., Act No. 40/1995 Coll., on regulation of
advertising and amending and supplementing Act No. 468/1991 Coll. on the operation of
radio and television broadcasting, as subsequently amended,
Act No. 13/1993 Coll. as amended, Act No. 563/1991
Coll., on accounting, as amended.
11A) article 18 of the United Nations Convention against illicit
trafficking in narcotic drugs and psychotropic substances, the renowned under no. 461/1991
SB.
11B) Act No. 79/1997 Coll., on pharmaceuticals and on changes and additions to the
some related laws, as amended.
11 c) Article. 1, 2, 13, 20 and 25 of Decree No. 47/1965 Coll.
11 d) Article. 1 and 2 of the Convention on psychotropic substances declared under no 62/1989
SB.
11e) Article. 1, 2, 13, 20 and 27 of Decree No. 47/1965 Coll.
11F) Article. 1, 2, 3, 12 and 16 of the Convention on psychotropic substances declared under
No 62/1989 Coll.
11 g) Article. 1, 12 and 19 of Decree No. 47/1965 Coll.
11 h) resolutions of the economic and Social Council of the United Nations
No 1981/7.
The implementation of the Convention on psychotropic substances of 1971.
Resolutions of the economic and Social Council of the United Nations.
1991/44.
Prevention of leakage of psychotropic substances list III and IV of the Convention on
psychotropic substances of 1971 to illicit channels in the international
trading.
11i) Article. 12 paragraph 1. 4 (a). 5 and article. 19 para. 3 Decree No. 47/1965 Coll.
11j) Article. 9. 1 Council Regulation (EEC) No 3677/90.
11 l) § 79 penal procedure.
11 m) Article. 5A paragraph 2. 3 Council Regulation (EEC) No 3677/90, as amended by regulation
Council Regulation (EEC) no 900/92.
11n) article 5 of Commission Regulation (EEC) No 3677/90, as amended by Council regulation
(EEC) no 900/92 and Council Regulation (EC) no 988/2002.
11o) § 309 to 312 of Act No. 13/1993 Coll.
12) Act No. 71/1967 Coll., on administrative proceedings (administrative code).
13) Government Regulation No 192/1988 Coll., on poison and some other substances
harmful to health, as amended.
14) Act No. 137/2006 Coll., on public procurement, as amended
regulations.
15) Act No. 553/1991 Coll. on State control, as amended
regulations.
16) Act No. 526/1990 Coll., on prices, as amended.
