What is Full text of Act No. 466 / 2004 Coll.?

Full text of Act No. 466 / 2004 Coll., Act No. 167 / 1998 Coll., on addictive substances and on the amendment of certain other laws, as seen from subsequent amendments — Full text of Act No. 167 / 1998 Coll., on addictive substances and on the amendment of certain other laws, as shown by later amendments.

When it became Full text of Act No. 466 / 2004 Coll. effectiveness?

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Is Full text of Act No. 466 / 2004 Coll. still valid?

Yes, Full text of Act No. 466 / 2004 Coll. is still valid and effective.

Full text of Act No. 466 / 2004 Coll. - Full text of Act No. 167 / 1998 Coll., o...

466

PRESIDENT OF THE GOVERNMENT

Announces

full version of Act No. 167 / 1998 Coll., on addictive substances and on the amendment of certain other laws, as is apparent from the amendments made by Act No. 354 / 1999 Coll., Act No. 117 / 2000 Coll., Act No. 132 / 2000 Coll., Act No. 57 / 2001 Coll., Act No. 185 / 2001 Coll., Act No. 407 / 2001 Coll., Act No. 320 / 2002 Coll., Act No. 223 / 2003 Coll. and Act No. 362 / 2004 Coll.

THE LAW

on addictive substances

Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

HLAVA I

INTRODUCTORY PROVISIONS

§ 1

Scope of the law

(1) This Act provides for:

(a) the treatment of addictive substances, of products containing addictive substances (hereinafter referred to as "preparations"), of certain substances used in the manufacture or processing of addictive substances (hereinafter referred to as "precursors") and of auxiliary substances, their export, import and transit operations, 1)

(b) the cultivation of poppy, hemp and coca and the export and import of macaroni.

(2) This Act does not apply to the treatment of precursors and auxiliaries (1a) contained in:

(a) medicines in pharmaceutical form, (2) with the exception of medicines containing ephedrine and medicines containing more than 30 mg of pseudoephedrine per unit of pharmaceutical form,

(b) in other products, where the composition of such products is such that precursors and excipients contained therein cannot be easily used or re-obtained in an easy-to-use manner, as provided for in the immediately binding regulation of the European Communities. (1a)

§ 2

Terms

For the purposes of this Act:

(a) substance addicts and psychotropic substances listed in Annexes 1 to 7 to this Law;

(b) a solution or mixture in any physical state containing one or more addictive substances;

(c) by precursor, the substance listed in Annex 9 to this Act, as well as a solution, mixture or natural product in any physical state containing one or more of the substances listed in Annex 9 to this Act, except those listed in Section 1 (2) of this Act;

(d) an excipient substance listed in Annex 10 or Annex 11 to this Act, as well as a mixture or natural product in any physical state containing at least one such substance, except those listed in Section 1 (2) (b) of this Act, 1a)

(e) the poppy seed of all the above-ground parts (except seeds) of the poppy seed (Papaver somniferum) and their pulp,

(f) hemp blossoming or fruiting plants of hemp (Cannabis) or the above-ground part of hemp with a peak;

(g) the coca bush all types of Erythroxylon shrub and the coca leaf leaves of the coca shrub with the exception of the leaves from which all ecgonin, cocaine and other ecgonin alkaloids have been extracted, 2a)

(h) the final consignee of the substances listed in Annexes 9 to 11 to this Act, any natural person or legal person under an immediately binding regulation of the European Communities, 2b)

(i) placing on the market the supply of substances listed in Annexes 9 to 11 to this Law produced in the countries of the European Community to a third party or for free circulation in the countries of the European Community, whether for consideration or free of charge;

(j) the export or import of addictive substances and preparations involves their physical transfer from one State to another. 2a), 2c)

HLAVA II

PRECIOUS AND ASSISTANT PREPARATIONS

§ 3

Treatment of substances and preparations

(1) Treatment of addictive substances and preparations means:

(a) research, production, processing, collection, storage, supply and use of addictive substances and preparations;

(b) the purchase and sale of addictive substances and preparations, as well as the acquisition and waiver of other rights in kind or in obligation associated with them, the brokering and representation of such contracts when they are concluded.

(2) The addicts listed in Annex 3 or 4 to this Act and preparations containing them may be used only for scientific and very limited therapeutic purposes as defined in the authorisation for treatment. Other addictive substances and preparations containing them may only be used for therapeutic, scientific, educational, veterinary or other purposes under the permission of the Ministry of Health.

§ 3a

Treatment of precursors and excipients

(1) Treatment of precursors means:

(a) production and marketing of precursors, including activities related thereto;

(b) the export, import and transit of precursors referred to in the immediately binding regulation of the European Community2d) from or into the customs territory of the European Community.

(2) Treatment of excipients means:

(a) the manufacture and placing on the market of the excipients listed in Annex 10 to this Law or mixtures thereof, except potassium permanganate;

(b) the export from the customs territory of the European Communities of the excipients referred to in the immediately binding regulation of the European Communities (2d), the importation of those substances into or transit through that customs territory of those substances.

(3) For the treatment of auxiliary substances, registration under Section 16 of this Act is required, unless otherwise provided for in this Act.

§ 4

Authorisation for treatment

The treatment of addictive substances, preparations and precursors requires authorisation for treatment, unless otherwise provided for in this Act.

§ 5

Treatment of addictive substances and preparations without authorisation

(1) The addicts listed in Annex 1, 2, 5, 6 or 7 to this Act and preparations containing them or preparations containing ephedrine and pseudoephedrine may, without authorisation for treatment:

(a) to acquire, detain and store persons operating a pharmacy (2e) only for the operation of a pharmacy;

(b) dispose, if not stored, of persons authorised to do so under the special legislation.3)

(2) Products containing addictive substances listed in Annex 1, 2, 5, 6 or 7 to this Act, and preparations containing ephedrine and pseudoephedrine may, without authorisation for treatment:

(a) only for the provision of health care to acquire, desist and store persons operating medical or institutional welfare facilities;

(b) only for the provision of veterinary care to acquire, retain and store natural or legal persons authorised to carry out professional veterinary activities;

(c) prescribe doctors when providing health care in health and social care establishments;

(d) use for therapeutic purposes doctors and other healthcare professionals in sleeper and outpatient health care establishments and in institutional welfare establishments;

(e) prescribe and use for veterinary purposes by veterinary surgeons, 4)

(f) according to the medical form completed and signed (hereinafter referred to as "the recipe") or the orders of natural and legal persons authorised to provide health care or veterinary care (hereinafter referred to as "the letter") to prepare and issue pharmacists in pharmacies,

(g) to take over and prepare pharmaceuticals in pharmacies by pharmacists or pharmaceuticals under the supervision of a pharmacist;

(h) to be acquired, including on behalf of, on the basis of a doctor given the recipe, by a natural person, on the basis of his or her own use,

(i) to acquire, including on behalf of, on the basis of a veterinary prescription, or to acquire from a natural or legal person authorised to carry out veterinary activities, to retain and use according to the prescription issued or the diagnosis provided for for in the provision of veterinary care by natural and legal persons;

(j) to acquire, retain, store, transport and use contracting entities and examiners in the preparation and conduct of a clinical trial of medicinal products for human use under a special law, 5)

(k) to acquire, retain, store, transport or use contracting entities or examiners in the preparation or conduct of a clinical trial of veterinary medicinal products under specific legislation. (a)

(3) The authorisation for treatment shall not be required for the transport of addictive substances, preparations and precursors by a person authorised to handle addictive substances, preparations and precursors.

(4) Without authorisation for treatment, limited quantities of products containing addictive substances listed in Annex 2, 6 or 7 to this Act and preparations containing ephedrine and pseudoephedrine may be transported in means of transport for international transport for first aid and for emergencies.

(5) No authorisation for the acquisition, storage and processing of hemp for industrial purposes (for fibres and seeds) and for experimental purposes, as well as for trade in hemp for those purposes shall be required.

(6) No authorisation for treatment shall be required for the activities of state bodies within their competence, for the activities of local self-governing bodies within their delegation and for the provision of local public order matters within their own competence and for the activities of the Army of the Czech Republic, the Police of the Czech Republic and the Customs Administration of the Czech Republic in the performance of their tasks.

(7) No treatment is required for the activities of legal or natural persons setting up judicial toxicology laboratories, laboratories of health institutions, specialised diagnostic, research and teaching centres of universities and specialised diagnostic and scientific research centres of the Czech Academy of Sciences, the list of which is established by the Ministry of Health by decree. The application for inclusion in this list shall be made using a form issued by the Ministry of Health.

(8) The authorisation for treatment shall not be required for persons operating a pharmacy who acquire, withhold and store addictive substances listed in Annexes 3 and 4 to this Act for the purpose of supplying them to the persons referred to in paragraph 7.

§ 6

Treatment of precursors without a treatment permit

(1) Precursors may:

(a) acquire, delay, process and store persons operating a pharmacy only for the operation of a pharmacy;

(b) to take over and prepare pharmaceuticals in a pharmacy under the supervision of a pharmacist;

(c) dispose, if not stored, of persons authorised to do so under the special legislation.3)

(2) No authorisation shall be required for the activities of public authorities within their competence, for the activities of local authorities within their delegation and for the provision of local public order matters within their own competence, for persons representing customs procedures, 5b), 5c) for storage deponents 5c) and for the activities of the Army of the Czech Republic, the Police of the Czech Republic and the Customs Administration of the Czech Republic in the performance of their duties.

(3) Authorisation for treatment is not required for the activities of persons referred to in Article 5 (7).

§ 7

The Ministry of Health may provide by decree for further cases where no authorisation for treatment is required for the treatment of addictive substances, preparations and precursors.

§ 8

Issue of a treatment permit

(1) The treatment permit is issued by the Ministry of Health. There is no legal right to issue a treatment permit.

(2) The authorisation for treatment only authorises the activities listed therein and, in the case of an authorisation for manufacture, the maximum volume of production of addictive substances, preparations or precursors may be specified therein. Changes in or extensions of authorised activities may only be made on the basis of a new authorisation for treatment. By issuing a new authorisation for treatment, the existing authorisation for treatment shall cease.

(3) Authorisation for treatment is granted for a period of 5 years. Where the applicant so requests, a treatment permit may be issued for a shorter period.

(4) The authorisation for treatment is non-transferable.

(5) A right of treatment may be granted only to a natural person who is resident in the Czech Republic or to a legal person established in the Czech Republic. The condition of permanent residence or registered office in the Czech Republic does not apply if it is a citizen of a Member State of the European Union, a citizen of the Czech Republic who does not reside in the Czech Republic, or a legal person established in a Member State of the European Union. The legal person shall be required to demonstrate the integrity of natural persons registered as authorised to act for it; a legal person who is not registered shall demonstrate the integrity of natural persons who are identified in the instruments of incorporation as authorised to act as such. For the purposes of this law, integrity is understood as the fact that a natural person has not been convicted of an intentional offence or of a malpractice offence involving the treatment of addictive substances, precursors and medicinal products. The integrity shall be demonstrated by an extract from the Register of Penalties not earlier than 3 months.

(6) A treatment permit may be issued only to a legal or natural person who has appointed the responsible person. This is not the case if the natural person proves that he meets the requirements imposed on the person responsible by this law.

(7) The application for authorisation for treatment shall be made using a form issued by the Ministry of Health. Where authorisation is sought for the manufacture of addictive substances, preparations and precursors listed in Annex 9 to this Act, the application shall be accompanied by a technical regulation of the intended production.

(8) The person who terminates the authorisation for treatment and intends to continue to treat addictive substances, preparations and precursors shall be required to submit to the Ministry of Health an application for a new authorisation for treatment no later than 6 weeks before the expiry of the authorisation for treatment.

(9) Any changes to the information contained in the application for a treatment permit shall be communicated in writing to the Ministry of Health without delay.

(10) (c) the Ministry of Health may decide to withdraw the authorisation for treatment. The Ministry of Health shall withdraw the authorisation for treatment if the holder of the authorisation has been convicted of a criminal offence the nature of which is linked to that activity. 5d)

(11) If a natural or legal person ceases to carry out an activity for which a treatment permit has been granted, he shall immediately notify the Ministry of Health which shall revoke the treatment permit by decision. An application for revocation of a treatment permit shall be made using a form issued by the Ministry of Health.

(12) Where the Ministry of Health decides not to issue a treatment permit or to issue a new treatment permit or to revoke a treatment permit by its decision, it shall specify in the decision the time limit for carrying out the cessation of operations and the way in which addictive substances, preparations and precursors are to be handled.

§ 9

Person responsible

(1) A person handling addictive substances, preparations and precursors on the basis of a treatment authorisation must have a responsible person designated throughout the period of validity of the treatment authorisation. This is not the case if the provision of the responsible person under the second sentence of Paragraph 8 (6) of this Act has been waived when the authorisation was granted.

(2) Person responsible

(a) for the records and documentation prescribed by this law;

(b) for the fulfilment of the reporting obligations laid down by this law.

(3) The person responsible may be appointed a natural person with permanent residence in the Czech Republic. The condition of permanent residence in the Czech Republic does not apply if it is a citizen of a Member State of the European Union or a citizen of the Czech Republic who does not reside in the Czech Republic. This person must fulfil the conditions of general, health and professional competence for the treatment of addictive substances.

(4) The medical fitness of the responsible person shall be demonstrated by a medical assessment which shall not be more than 3 months old on the day of the provision of the responsible person. The medical assessment shall be carried out by the medical assessor on the basis of the result of a medical examination or any other professional examinations. In cases where the person responsible is an employee in the employment relationship, the assessor is a doctor of the preventive care plant, in other cases a registered practitioner. A person who has a reasonable suspicion that his or her health or the life of other persons would be at risk in the performance of his or her duties may not be recognised as a competent person.

(5) The person responsible may only be appointed as a member of a staff member in an employment contract for a specified week's working time, or as a member of a public company, an associate of a limited partnership, a manager of a limited liability company, a member of the board of directors of a public limited company or a cooperative, a member of the board of directors of a public utility company or a procurer.

(6) The internal rules issued by a person who is obliged to appoint a responsible person must ensure that the activities for which authorisation for treatment is required cannot be carried out without the consent of the responsible person.

(7) The responsible person shall co-sign:

(a) an application for a treatment permit;

(b) an application for an export permit or import authorisation;

(c) reports submitted in the context of the fulfilment of reporting obligations under this Act.

(8) The person responsible who is not an employee may renounce his duties by means of a written notification to the person for whom he carries out the duties of responsible person.

(9) Where the responsible person or person carrying out his or her function under Paragraph 8 (6) is temporarily unable to perform his or her duties, the person who has been granted the authorisation shall immediately appoint a representative of the responsible person. The provisions of the representative of the responsible person and the termination of his duties shall be communicated without delay in writing to the Ministry of Health. The representative of the responsible person shall comply with the general, health and professional qualifications laid down by this law for the responsible person.

(10) If the responsible person no longer fulfils the conditions laid down, or for other reasons is permanently unable to perform his or her duties or renounces his or her duties, the person who has been granted a treatment permit shall be obliged to appoint a new responsible person within 10 days and request the Ministry of Health to change the treatment permit. The application for a change of treatment permit shall be made on a form issued by the Ministry of Health and shall be co-signed by the newly appointed responsible person.

§ 10

Storage

(1) The addicts, preparations and precursors must be stored in locked rooms, the walls, ceilings, floors, windows and doors of which are made of materials which make penetration into stored materials more difficult, or in non-portable steel lockable containers or in special purpose lockable devices which are inseparably anchored to walls, ceilings or floors made of solid materials (for example, bricks or concrete panels).

(2) Keys to rooms where addictive substances, preparations and precursors are stored can only be issued to designated persons and must be stored separately from keys to other rooms in the building.

(3) Staged addictive substances, preparations and precursors as well as manufacturing equipment for their production must be protected against loss, theft and abuse, in particular by continuous physical surveillance and appropriate technical means (fencing, electronic security equipment, etc.).

(4) The obligations referred to in the preceding paragraphs need not be fulfilled in storage for which no authorisation is required. However, storage in such cases must be ensured in such a way that unauthorised persons do not have access to stored substances. In medical establishments, social care establishments and for persons authorised to provide veterinary care, they shall be stored in non-portable lockable containers of a metal addictive substance listed in Annex 1, 3, 4 or 5 to this Act and the preparations containing them.

§ 11

Transport

(1) The addicts listed in Annex 1, 3, 4 or 5 to this Act, preparations containing them and precursors may only be transported in lockable metal containers or in specially designed luggage fitted with a lock mechanism or in a enclosed space of means of transport so that such substances cannot escape outside the enclosed space. During loading, transport and unloading, the carrier shall ensure continuous surveillance. Transport routes must be changed irregularly and must not be published.

(2) The substances referred to in Annex 1, 3, 4 or 5 to this Act, preparations containing them and precursors must be labelled in such a way that it can be ascertained that they are substances, preparations or precursors, the marking being made in such a way that unauthorised persons cannot determine what is being transported.

§ 12

Trade

(1) Narcotic substances, preparations and precursors may only be sold to persons authorised to handle them. The same applies to the transfer of other rights associated with addictive substances, preparations and precursors.

(2) Excipients listed in Annex 10 to this Act, with the exception of potassium permanganate, may be transmitted or sold only to persons who submit to the transmitting or selling a completed declaration to the customer in accordance with the immediately binding provisions of the European Communities. 5f)

(3) The obligation referred to in paragraph 2 shall not apply to persons who intend to transmit or sell any of the excipients listed in Annex 10 to this Act whose total quantity does not exceed the quantity laid down by the Ministry of Health in the calendar year of the decree.

(4) Persons intending to manufacture, import, export, transfer or sell precursors and excipients listed in Annex 10 to this Act are required to ensure that they are labelled before they are placed on the market. The label shall bear the name of the substance which must correspond to the annexes to this Act, 5g) and may bear its normal trade description; A similar designation is required in transit of precursors and excipients (Section 23).

§ 13

Formula forms and blue stripe requests

(1) Medicinal products (6) containing addictive substances and medicinal products containing ephedrine and medicinal products containing more than 30 mg pseudoephedrine per unit of pharmaceutical form may be issued in a pharmacy to a person who has not been authorised for treatment only for a prescription or a requisition. In the case of medicinal products containing addictive substances listed in Annexes 1 and 5 to this Act, the recipe or demand must be marked with a blue stripe from the lower left corner to the upper right corner. In the case of medicinal products containing addictive substances listed in Annexes 1 and 5 to this Act and listed in Annex 8 to this Act at the same time, they may be issued in a prescription pharmacy or a requisition without a blue stripe.

(2) Prescription forms and blue-striped applications bearing the serial number of the form and the code of the municipal office of the municipality of extended competence which issued them are subject to registration.

(3) Prescription forms and blue stripe applications may be ordered and withdrawn from the local competent municipal authority of the municipality with extended scope only by the persons referred to in § 5 (2) (a) and (b) of this Act through their authorised representatives. These persons shall keep a record of any further use.

(4) The production and distribution of recipes and requests with a blue stripe are provided by municipal authorities with extended scope.

(5) The municipal authorities of the municipalities with extended scope of registration shall keep a record of the expenditure, recovery and depreciation of returned recipes and blue-striped requests.

(6) Impaired recipes or requests with a blue stripe shall be handed over to the municipal authority of the municipality with the extended scope which issued them.

(7) Persons who have ceased to comply with the conditions laid down in § 5 (2) (a) and (b) of this Act are obliged to submit, through their authorised representatives, unused or degraded recipes or requests with a blue stripe within 5 days to the municipal authority of the municipality with extended scope which issued them. The municipal authority of the municipality shall issue a certificate of receipt of the forms submitted.

(8) In the event of the death of a person who has been issued with recipes or requests with a blue stripe authorised by a representative or directly by the municipal authority of a municipality with extended scope, the person who has lived with the deceased in the common household shall be obliged to submit the forms within 10 days of the date of death to the authorised representative if the person who has been engaged in an activity in employment or in a similar relationship, in other cases, to the municipal office of the municipality with extended scope.

(9) Specific legislation provides for the distribution, return, disposal and keeping of recipes and blue-striped vouchers. 6a)

(10) Medicinal products containing addictive substances and medicinal products containing ephedrine and pseudoephedrine cannot be re-issued per recipe.

(11) The Ministry of Defence and the Ministry of Finance issue prescription forms and blue-striped applications for health and veterinary establishments under their responsibility, indicating the Ministry's code. The provisions of paragraphs 2 to 8 shall apply mutatis mutandis to the handling of such forms, with the provision that the Ministry of Defence or the Ministry of Finance, instead of the Municipal Office of the Municipality with extended scope, provides the specified activities.

§ 14

Disposal of waste and excess and unused substance, preparations and precursors

(1) Useless addicts, preparations and precursors, as well as waste containing them, must be disposed of.

(2) The disposal of unused addictive substances, preparations and precursors, as well as waste containing them, which are medicinal products, is governed by specific legislation. (b)

(3) The disposal of unused addictive substances, preparations and precursors, as well as waste containing them, which are not medicinal under a special law, (6) can only be carried out in the presence of a representative of the Regional Office. The person carrying out the disposal shall write a record thereof, signed by a representative of the Regional Office present.

§ 15

Prohibitions

It shall be prohibited:

(a) place addictive substances and preparations in customs warehouses, free zones and free warehouses, 7)

(b) import and export precursors and excipients for the reasons set out in the immediately binding Regulation of the European Communities, 7a)

(c) send addictive substances, preparations and precursors

1. by post as ordinary consignments,

2. via mailboxes; or

3. persons who are not authorised to handle addictive substances,

(d) to transmit to another person in any way,

(e) to obtain opium from seed (Papaver somniferum),

(f) to obtain cannabis resin and substances from the group of tetrahydrocarbinols from the hemp plant (Cannabis genus),

(g) advertising of addictive substances, preparations and precursors.

§ 16

Registration of producers, exporters, importers and persons placing the active substances on the market

(1) Persons intending to produce, export, import, place on the market or deal with the transit of the excipients listed in Annex 10 to this Act, with the exception of the production and placing on the market of potassium permanganate, and persons intending to export the auxiliary substances listed in Annex 11 to this Act, are required to register with the Ministry of Health before commencing the activity. The application for registration shall be made in duplicate on forms issued by the Ministry of Health.

(2) The obligation referred to in paragraph 1 shall not apply to persons intending to export any of the excipients listed in Annex 11 to this Law whose total quantity does not exceed the quantity in a calendar year in accordance with the immediately binding regulation of the European Communities. (c)

(3) Registration may be issued only to natural or legal persons meeting the conditions laid down in Article 8 (5).

(4) Any changes to the data contained in the registration shall be communicated in writing to the Ministry of Health without delay.

(5) If a natural or legal person ceases to carry out an activity which has been the subject of registration, he shall immediately notify the Ministry of Health which shall cancel the registration.

(6) The Ministry of Health shall decide, for the persons referred to in paragraph 1, to reject the application for registration or to suspend, withdraw or revoke the marketing authorisation already issued

(a) where false or incomplete information is found in the application for a marketing authorisation;

(b) in the event of a breach of obligations under this law or of a decision given under it; or

(c) where the holder of the registration has been convicted of a criminal offence the nature of which relates to that activity, unless he is regarded as not being convicted.

HLAVA III

ELIGIBILITY FOR PRECIOUS PRODUCTS, PRECIOUS PRODUCTS AND PRECIOUS PRODUCTS

§ 17

General eligibility

(1) The activities for which authorisation for treatment is requested, as well as those referred to in points (a), (2) (a) and (b) of Article 5 (2) and (6) and in points (a) and (2) of Article 6 (1) and in which addictive substances, preparations and precursors are brought into direct contact may only be carried out by natural persons eligible for legal action and older than 18 years. The integrity shall be demonstrated by an extract from the Register of Penalties not earlier than 3 months.

(2) The conditions referred to in paragraph 1 shall also be met by natural persons directly managing the activities referred to in paragraph 1.

§ 18

Health

(1) The activities for which authorisation for treatment is requested, as well as those referred to in points (a), (2) (a) to (g) and (6) and in points (a) and (2) of Article 6 (1) and in which substances, preparations and precursors come into direct contact with addicts are not to be carried out by natural persons in whose organism the substance is present unless it is the presence of an addictive substance because of a doctor prescribed treatment.

(2) The conditions referred to in paragraph 1 shall also be met by natural persons directly managing the activities referred to in paragraph 1.

(3) The staff of persons carrying out the activities referred to in paragraphs 1 and 2 are required to undergo a medical examination at the employer's request to detect the presence of an addictive substance in the organism.

§ 19

Professional competence

(1) A natural person who has achieved a university Master's degree in pharmacy, medicine, veterinary medicine or chemical technology may be designated as the responsible person.

(2) Anyone who carries out activities for which authorisation is required, as well as those referred to in Article 5 (1) (a) and (2) (a) and (b) and in Article 6 (1) (a), and where directly in contact with, or directly controlling, addictive substances, preparations and precursors is required, must ensure that natural persons who come into direct contact with, or directly control, such activities acquire knowledge of the nature and effects of such substances and their handling.

HLAVA IV

EXPORT, IMPORTATION AND TRANSIT OPERATIONS

§ 20

Exports of addictive substances and preparations containing them

(1) Each individual export of addictive substances and preparations is subject to the authorisation of the Ministry of Health ("export authorisation"). Such authorisation shall not replace the export authorisation in accordance with specific rules. 8)

(2) No export authorisation is required

(a) to export mass-produced medicinal products containing addictive substances listed in Annex 2, 6, 7 or 8 to this Act, or products containing ephedrine or pseudoephedrine, if they are exported by a doctor for the purpose of providing first aid or by a veterinarian for the purpose of providing urgent veterinary care for the transport of animals or by a natural person for his own use, in quantities and species corresponding to the length of the journey and medical condition as specified in the diagnosis;

(b) to export products listed in Annex 8 to this Act or products containing ephedrine or pseudoephedrine, where the export is carried out by a person authorised to treat the products listed in Annex 8 to this Act or preparations containing ephedrine or pseudoephedrine;

(c) to export a limited quantity of products containing addictive substances listed in Annex 2, 5, 6, 7 or 8 to this Act, or preparations containing ephedrine or pseudoephedrine in vehicles intended for international transport for the purpose of providing first aid or emergency assistance;

Citation	Full text of Act No. 466 / 2004 Coll., Act No. 167 / 1998 Coll., on addictive substances and on the amendment of certain other laws, as seen from subsequent amendments
Regulation Type	Declared full text
Author	-
Collection	Code of Laws

Date of Promulgation	13.08.2004
Effective from	-
Effective until	-
Status	Valid

Full text of Act No. 466 / 2004 Coll.

Full text of Act No. 167 / 1998 Coll., on addictive substances and on the amendment of certain other laws, as shown by later amendments

Contents