What is Act No. 167 / 1998 Coll.?

Act No. 167 / 1998 Coll., on addictive substances and on the amendment of certain other laws — Law on addictive substances and on the amendment of certain other laws.

When it became Act No. 167 / 1998 Coll. effectiveness?

Act No. 167 / 1998 Coll. became effective 01.01.1999.

Is Act No. 167 / 1998 Coll. still valid?

Yes, Act No. 167 / 1998 Coll. is still valid and effective.

How many times was it Act No. 167 / 1998 Coll. amended?

Act No. 167 / 1998 Coll. has 38 time versions of the text.

Act No. 167 / 1998 Coll. - Law on addictive substances and on the a...

167

THE LAW

of 11 June 1998

on addictive substances and on amending some other laws

Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

HLAVA I

INTRODUCTORY PROVISIONS

§ 1

Subject matter

(1) This Act provides for:

(a) the treatment, export, import and transit operations of addictive substances;

(b) the treatment of products containing an addictive substance, of products containing an addictive substance and of that substance of category 1 pursuant to the directly applicable European Union drug precursor regulation (1) (hereinafter referred to as "category 1 substance") and medicinal products containing that substance of category 1, their export, import and transit operations;

(c) the cultivation of poppy, hemp and coca and the export, import and disposal of macaquin; and

(d) the treatment of psychomodulatory substances and psychoactive substances included.

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

§ 2

Terms

(1) For the purposes of this Act:

(a) addictive substances of narcotic substances and psychotropic substances of natural or synthetic origin which have a psychoactive effect while being listed in some of the Annexes 1 to 7 to the Government's Ordinance on the List of Addictive Substances, with the exception of cannabis extract and tincture, which contains a maximum of 1% of the substances of the tetrahydrocaninol group and fulfils the safety condition of the General Product Safety Act;

(b) a solution or mixture in any physical state containing an addictive substance or an addictive substance and a scheduled substance of category 1 or a medicinal product containing that substance of category 1, with the exception of a solution or mixture containing a substance of hemp extract and tincture containing not more than 1% of the substances of the tetrahydrocannabinol group; the substance cannabis extract and tincture must contain the solution or mixture in such a quantity that it cannot be misused or easily available or economically extracted from the solution or mixture. Such a solution or mixture must comply with the safety condition of the General Product Safety Act,

(c) all above-ground parts (except seeds) of poppy seed (Papaver somniferum L.) and their powder after harvesting, with the exception of whole poppy plants including capsules intended for ornamental purposes;

(d) a hemp flowering or fruitful peak of a plant of the genus hemp (Cannabis) or an upper part of a plant of the genus hemp with a tip included;

(e) hemp for the therapeutic use of hemp which is intended by the manufacturer for therapeutic purposes in humans or for processing for that purpose;

(f) a hemp plant for therapeutic use of a hemp plant grown for the production of hemp for therapeutic use;

(g) a plant of technical hemp, a plant of the genus hemp, from which hemp containing not more than 1% of the substances of the tetrahydrocaninol group may be obtained, or from seeds of the varieties listed in the Common Catalogue of Varieties of Agricultural Plant Species (2f), and technical hemp from a plant of technical hemp,

(h) the production of cannabis by a process consisting in the extraction of cannabis from a hemp plant;

(i) the coca bush all species of the Erythroxylon family and the coca leaf leaves of the coca bush, except for the leaves from which all ecgonin, cocaine and other ecgonin alkaloids have been extracted, 2a)

(j) the export or import of addictive substances, preparations containing them and the macaquin of their physical transfer from one country to another, 2a), 2c)

(k) cannabis extract for therapeutic use of extract produced from cannabis for therapeutic use intended for the preparation of individually prepared medicinal production2g) under the conditions of good manufacturing practice of manufacturers of active substances under the Drug Act;

(l) psychomodulatory substances of the new psychoactive substances 2h) and other substances with psychoactive effect which do not pose a serious risk to public health or the risk of serious social impacts on individuals and society and are also listed in the Government Regulation on the list of psychomodulators and their products;

(m) the production of psychomodulatory substances for cleaning, sorting, processing, packaging and other treatment of psychomodulatory substances for marketing;

(n) the placing on the market of psychomodulators of any supply of psychomodulators to the final consumer;

(o) the distribution of psychomodulators to purchase them for resale and sale; the placing on the market of psychomodulators is not considered as distribution,

(p) by unit packaging of the psychomodulatory substance, the individual packaging of the psychomodulatory substance placed on the market;

(q) the import of psychomodulators by physical transfer to the Czech Republic;

(r) the export of psychomodulators by physical transfer outside the Czech Republic;

(s) classified psychoactive substances of new psychoactive substances which, in the light of scientific knowledge, cannot be excluded from serious health and social risks while being included in the Government Regulation on the list of classified psychoactive substances and products thereof,

(t) psilocybin for the therapeutic use of psilocybin, which is intended for human therapeutic purposes by the manufacturer.

(2) The implementing legislation for cannabis extracts for therapeutic use provides for methods of production of cannabis extract for therapeutic use, the analytical methods used for testing active substances, the conditions for labelling and storage of cannabis extract for therapeutic use, as well as the way in which it is processed as a feedstock when preparing individually prepared medicinal products under the Drug Act.

HLAVA II

PREPARATION OF COPPER PRODUCTS AND 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 and production of hemp;

(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 the Government Ordinance on the list of addictive substances and preparations containing them may only be used for limited research, 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.

(3) By way of derogation from Section 4, psilocybin for therapeutic use may be used for limited therapeutic purposes in accordance with this Act in psychiatric hospitals and psychiatric hospitals which are directly under the responsibility of the Ministry of Health and in psychiatric centres of outpatient, stationary or berth care which are part of hospitals under the direct responsibility of the Ministry of Health, only by a doctor with specialised competence in the specialisation of psychiatry or special specialisation in the extension field of medical psychotherapy, who will exercise special supervision under § 33l. Psilocybin for therapeutic use may be used on the basis of a permit in medical institutions which are not directly covered by the Ministry of Health.

§ 4

Authorisation for treatment

For the treatment of addictive substances and preparations, authorisation for treatment shall be required, 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 the Government Ordinance on the list of addictive substances and preparations containing them or medicinal products containing Category 1 substances may, without authorisation for treatment:

(a) acquire, delay and store persons providing medical care 2e) only for the operation of a pharmacy;

(b) dispose, if not stored, of persons authorised under a special law, 3)

(c) prepare pharmaceuticals or pharmaceutical assistants under the supervision of the pharmacist.

(2) Products containing addictive substances listed in Annex 1, 2, 5, 6 or 7 to the Government Regulation on the list of addictive substances and medicinal products containing that substance, category 1, may, without authorisation for treatment:

(a) only for the provision of health services to acquire, desist and store health service providers;

(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 services;

(d) use for therapeutic purposes doctors and other healthcare professionals in hospital and outpatient care and in residential social services establishments or doctors who have a contract for the prescription of medicinal products with a health insurance company;

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

(f) prepare and supply pharmacists at the pharmacy on the basis of a prescription;

(g) to take over pharmaceuticals or pharmaceutical assistants under the supervision of a pharmacist;

(h) for own use:

1. acquire, including on a representative basis, on the basis of a recipe issued under the Drug Act (hereinafter referred to as the "recipe") natural persons,

2. acquire natural persons on the basis of equipment provided by the health service provider under the Law on Medicines,

3. to acquire, in the case of authorised medicinal products containing a scheduled substance, category 1 under the conditions laid down in the marketing authorisation, a natural person,

4. store and use according to a prescription issued or by a natural person's doctor,

(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, 5a)

(l) to store persons operating facilities providing residential social services.

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

(4) Without authorisation for treatment, limited quantities of products containing addictive substances listed in Annex 2, 6 or 7 to the Government Ordinance on the list of addictive substances and medicinal products containing category 1 scheduled substance may be transported in international transport vehicles for the provision of first aid and for emergencies.

(5) Authorisations for the treatment of plants of technical hemp or of technical hemp, in particular for industrial, food, cosmetic, technical or garden purposes, shall not be required.

(6) No authorisation is required for the activities of state bodies within their competence, for the activities of territorial authorities within their delegation and for the provision of local matters of public order within their own competence and for the activities of the Army of the Czech Republic, the Police of the Czech Republic, the General Inspection of Security Corps, the Prison Services 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. A request for inclusion in this list and a request for modification of the information contained in the list shall be made using a form issued by the Ministry of Health.

(8) Any changes to the information contained in the list referred to in paragraph 7 shall be notified in writing to the Ministry of Health without delay.

(9) The authorisation for treatment shall not be required for persons operating a pharmacy that acquires, withdraws and stores addictive substances listed in Annexes 3 and 4 to the Government Ordinance on the list of addictive substances for the purpose of supplying them to the persons referred to in paragraph 7.

(10) Narcotic substances listed in Annex 3 or 4 to the Government Ordinance on the list of addictive substances and preparations containing them may be disposed of, if not stored, by persons on the basis of consent granted by the Regional Authority.) The Ministry of Health shall inform the Regional Authority which granted the consent of the granting of the consent. This information shall be provided on a form issued by the Ministry of Health.

(11) Products containing addictive substances listed in Annex 2, 6 or 7 to the Government Ordinance on the list of addictive substances may be issued by pharmaceutical assistants at a pharmacy without authorisation on the basis of a request issued by a doctor under the Drug Act ("the requisition ').

(12) No authorisation for the maintenance of cannabis narcotic substances or other addictive substances derived from the processing of cannabis plants containing more than 1% of the substances of the tetrahydrokanabinol group by natural persons over 21 years of age for their own use shall be required.

(a) 100 g in his home, apartment or other living space, or accessories thereto (hereinafter referred to as "dwelling"); or

(b) 25 g outside its dwelling.

(13) The authorisation for treatment shall not be required for the cultivation, harvesting or processing of cannabis plants by natural persons over 21 years of age for their own use in total quantities of up to 3 cannabis plants, in immovable property owned or otherwise in their legal relationship.

§ 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 and preparations.

§ 8

Issue of a treatment permit

(1) The treatment permit is issued by the Ministry of Health. No authorisation shall be granted where a person fails to comply with the requirements laid down in paragraph 6 or the intended purpose of treatment of addictive substances or preparations is contrary to § 3 (2) or contrary to the public interest protected by this law or contrary to an international agreement governing the treatment of addictive substances to which the Czech Republic is bound.

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

(3) Authorisations for the treatment of addictive substances and preparations are issued for a maximum period of 5 years.

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

(5) An authorisation for treatment may be granted only to a legal or business person who has appointed the responsible person. This shall not apply if the natural person undertaking proves that he or she meets the requirements imposed on the person responsible by this law.

(6) The application for authorisation for treatment shall be made using a form issued by the Ministry of Health. The application shall be accompanied by:

(a) the original, a copy or an officially certified copy of the decision proving the authorisation for the treatment of medicinal products under the Medicines Act or the certificate of compliance with the conditions for carrying out veterinary medicinal and preventive activities under the Veterinary Chamber Act, where the treatment of addictive substances contained in medicinal products and medicinal substances under the Medicinal Products Act is the subject of an application);

(b) proof of integrity where the procedure laid down in Article 8a (4) is not possible;

(c) proof of the business permit;

(d) a document containing the consent of the property owner to the activities specified in the application;

(e) a contract on professional veterinary activities, where that activity is carried out;

(f) proof of the provision of the person responsible in accordance with paragraph 5;

(g) evidence of medical fitness of the responsible person in accordance with Article 9 (4);

(h) proof of professional competence of the responsible person in accordance with Article 19 (1);

(i) a statement by the applicant that, in the case of activities involving direct contact with addictive substances and preparations, the appropriate means of securing them shall be chosen in accordance with Sections 10 and 11;

(j) a description of the technology of the intended production as regards the application for authorisation for the manufacture of addictive substances and preparations;

(k) a statement by the applicant that the establishment referred to in the second sentence of Article 3 (3) which it intends to use for therapeutic purposes psilocybin for therapeutic use has ensured the presence of a physician with specialised competence in the specialisation field of psychiatry or in the specialisation field of medical psychotherapy, who will exercise special supervision under Section 33l.

(7) The person who terminates the authorisation for treatment and intends to continue to handle addictive substances and preparations is 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.

(8) 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.

(9) In the event of a change in the information contained in the application for a treatment permit concerning the change

(a) in already authorised activities or their extension;

(b) the name, registered office, legal form, if it is a legal person; or

(c) residence and place of business, if different from residence, if it is a natural person;

the person intending to make these changes must submit a new application to the Ministry of Health for a treatment permit.

(10) 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) The holder of a treatment permit which has been withdrawn may apply for a new treatment permit not earlier than two years after the date on which the decision to withdraw the treatment permit became final. This applies mutatis mutandis to a legal person whose statutory authority is the person who was the statutory authority of the holder of the authorisation for treatment when the validity of the authorisation for treatment was withdrawn.

(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) If 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 the substance and preparations are to be handled.

(13) A person who has been granted a new treatment permit shall be required to return an invalid treatment permit to the Ministry of Health within 14 days of the date on which the new treatment permit is acquired. This obligation shall also apply to persons who end up with a treatment permit pursuant to paragraph 7 and who no longer intend to handle addictive substances and preparations; the period for returning the invalid treatment permit shall be 14 days from the date of expiry of the treatment permit.

(14) The Ministry of Health shall issue an authorisation for treatment at the request of a medical establishment in accordance with Article 3 (3), which shall demonstrate that at the date of application it fulfils the conditions under this Act for the administration of psilocybin for therapeutic use; The Ministry of Health shall withdraw the authorisation for treatment if the holder of the authorisation no longer fulfils the conditions for administration of psilocybin for therapeutic use.

§ 8a

integrity

(1) A right of treatment may be granted only to a legal person established in the Czech Republic or to a legal person established in the Czech Republic. The residence condition in the Czech Republic shall not apply if it is a person who has his place of business, registered office, central administration or principal place of business in the territory of another Member State of the European Union, the Contracting State of the Agreement on the European Economic Area or the Swiss Confederation.

(2) For the purposes of this Act, the righteous are those who have not been convicted of an intentional or negligent offence committed in connection with the treatment of addictive substances or preparations, psychomodulatory substances or psychoactive substances.

(3) The integrity is demonstrated

(a) an extract from the Register of Penalties, not more than 3 months old

1. in the case of a natural person with a permanent residence or other residence in the Czech Republic,

2. in the case of a natural person who is or has been a national of another Member State of the European Union or in another Member State of the European Union, has or has been resident; the extract must be accompanied by an annex in accordance with the Penal Register Act,

3. in the case of a legal person established in the Czech Republic,

(b) evidence of a similar statement from the Register of Penalties

1. for a natural person with a place of permanent residence or other residence outside the Czech Republic and for a natural person who has remained continuously outside the Czech Republic for a period of more than 6 months in the last 5 years; a document similar to the extract from the Register of Penalties must be issued for that purpose by the competent authority of the State of permanent or other residence of that person, of the States in which that person has been continuously present for more than 6 months in the last 5 years and of a State which is not the same as the State of permanent residence or other residence of that person, and that person is a citizen of that person;

2. in the case of a legal person established outside the Czech Republic; a document similar to the extract from the Register of Penalties must be issued for that purpose by the competent authority of the State of residence;

(c) an honest declaration of integrity

1. in the case of a natural person, unless the State of residence or other residence of the natural person and the State where the natural person has been present continuously during the last 5 years, the document referred to in point (b); an affidavit of integrity shall be made before a notary or an authorised authority of the State of permanent or other residence of that person and of the States in which that person has remained continuously for more than 6 months in the last 5 years;

2. in the case of a legal person, unless the State of the legal person's registered office issues the document referred to in point (b); a declaration of integrity must be made before a notary or an authorised authority of the State of residence.

(4) In order to demonstrate the integrity of persons referred to in paragraph 3 (a) (1) and (3), the Ministry of Health shall obtain an extract from the Register of Penalties under the special legislation 5f. An application for an extract from the Register of Penalties and an extract from the Register of Penalties shall be sent in electronic form in a way that allows remote access. The Ministry of Health may also obtain additional supporting documents if necessary to verify the information established in accordance with paragraph 3.

§ 9

Person responsible

(1) A person handling addictive substances and preparations on the basis of a treatment authorisation must have a responsible person established 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 Section 8 (5) of the Act was 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, medical and professional competence.

(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. 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 person who has been granted a treatment permit must ensure that the activities for which a treatment permit is required are not carried out without the consent of the person responsible.

(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 (5) 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 office shall be communicated without delay in writing on a form issued by 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) Addictive substances and preparations must be stored in locked rooms, the walls, ceilings, floors, windows and doors of which are made of materials which make penetration into stored substances more difficult, or in non-portable steel lockable containers or in special purpose lockable devices inseparably anchored to walls, ceilings or floors made of solid materials (for example, bricks or concrete panels).

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

(3) Staged addictive substances and preparations as well as manufacturing equipment for their production or cultivation 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 services establishments and 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 the Government Ordinance on the list of addictive substances and preparations containing them.

§ 11

Transport

(1) The addicts listed in Annex 1, 3, 4 or 5 to the Government Ordinance on the list of addictive substances and preparations containing them 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 as to prevent the release of such substances 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 addictive substances listed in Annex 1, 3, 4 or 5 to the Government Ordinance on the list of addictive substances and preparations containing them must be labelled on transport in such a way that it can be established that they are substances and preparations, the labelling being carried out in such a way that unauthorised persons cannot determine what is being transported.

§ 12

Trade

Narcotic substances and preparations may only be passed on or sold to persons authorised to handle them. The same applies to the transfer of other rights associated with addictive substances and preparations.

§ 13

Prescription and dispensing of medicinal products containing highly addictive substances

(1) A medicinal product containing an addictive substance listed in Annex 1 or Annex 5 to the Government Ordinance on a list of addictive substances which is not listed at the same time in Annex 8 to the Government Ordinance on the list of addictive substances may be prescribed by a physician and issued by a pharmacist only to:

(a) a recipe produced in electronic form (the "electronic recipe") marked "highly addictive substance,"

(b) a recipe with a blue stripe drawn up in paper form, in exceptional cases where the conditions laid down by the Law on Medicinal Products (17) are met, for the issue of a recipe in paper form; a recipe with a blue stripe cannot be prescribed and issued a medicinal product containing cannabis or psilocybin for therapeutic use; or

(c) a request with a blue stripe displayed in paper form.

(2) In the case referred to in paragraph 1 (a) or (b), when prescribing the medicinal product and the pharmaceuticals at the dispensary, a physician is required to instruct the patient or the person representing the patient in an appropriate manner that a medicinal product containing a highly addictive substance is prescribed and issued.

(3) A medicinal product containing an addictive substance listed in Annex 1 or 5 to the Government Ordinance on a list of addictive substances not listed at the same time in Annex 8 to the Government Ordinance on the list of addictive substances may be prescribed for the treatment of animals by a veterinarian solely for the provision of veterinary care and a pharmacist issued at a pharmacy only on:

(a) a recipe with a blue stripe displayed in paper form, or

(b) a request with a blue stripe displayed in paper form.

(4) Blue stripe recipes and vouchers are issued in the form of forms. Forms of recipes and requests with a blue stripe indicating the serial number of the form and the code of the municipal office with extended scope issued by the municipality shall be subject to registration.

(5) Prescription forms and blue-striped 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.

(6) The production and distribution of recipes and blue-striped forms are provided by the municipal authorities with extended scope.

(7) Receipts, stocks, output, return and depreciation of returned recipes and blue-striped applications are kept by the municipal authorities with extended coverage. An annual inventory shall be carried out within this register on the last day of the calendar year.

(8) 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.

(9) Persons who have ceased to comply with the conditions laid down in Article 5 (2) (a) and (b) of this Act are required to submit, through their authorised representatives, unused or invalidated 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.

(10) 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.

(11) The implementing act provides for:

(a) the model of the blue stripe recipe, which is displayed in paper form, and the model of the blue stripe demand, which is displayed in paper form,

(b) the particulars given on the blue-striped recipe, which shall appear in the paper form referred to in paragraph 1, its period of validity and the rules governing its use;

(c) the particulars indicated on requests with a blue stripe, which shall appear in paper form in accordance with paragraph 1, its period of validity and the rules governing its use;

(d) the rules and method of distribution, record keeping, return and disposal of recipes and blue stripe requests;

(e) the data on the blue-striped recipe, which shall be presented in paper form in accordance with paragraph 3, its period of validity, restrictions on the type and quantity of medicinal products for the treatment of animals prescribed therein and the rules for its use;

(f) data to be provided on requests with a blue stripe, which shall be presented in paper form in accordance with paragraph 3, its period of validity, restrictions on the type and quantity of medicinal products for the treatment of animals prescribed therein and the rules for its use.

(12) The Ministry of Defence shall issue, for health and veterinary establishments falling within its competence, recipes and blue-striped applications with the Ministry's code. The provisions of paragraphs 4 to 10 shall apply mutatis mutandis to the handling of such forms, with the Ministry of Defence providing, instead of the municipal office of the municipality with extended competence, the specified activities.

§ 14

Disposal of waste and surplus and unused addictive substances and preparations

(1) Unusable addictive substances and preparations as well as waste containing them must be disposed of. The person responsible for the disposal of unused addictive substances and preparations and waste shall make a note thereof.

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

(3) The disposal of unused addictive substances and preparations, 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.

Citation	Act No. 167 / 1998 Coll., on addictive substances and on the amendment of certain other laws
Regulation Type	-
Author	-
Collection	Code of Laws

Date of Promulgation	15.07.1998
Effective from	01.01.1999
Effective until	-
Status	Valid

Act No. 167 / 1998 Coll.

Law on addictive substances and on the amendment of certain other laws

Contents

ČÁST PRVNÍ

HLAVA I

§ 1

§ 2

HLAVA II

§ 3

§ 4

§ 5

§ 7

§ 8

§ 8a

§ 9

§ 10

§ 11

§ 12

§ 13

§ 14

Contents

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