Act No. 271 / 1949 Coll.

Law on the production and distribution of pharmaceuticals

Valid Effective from 01.01.1950
271.
Law
of 19 December 1949
on the production and distribution of medicines.
The National Assembly of the Czechoslovak Republic decided on the following Act:

Část I.

Basic provisions on the production and distribution of medicines.
§ 1.
In order to ensure the right of the people to health protection and successful treatment of valuable medicines, the production, import, export and distribution of medicines shall be governed by a plan forming part of the national economic plan.
§ 2.
(1) State and national manufacturing undertakings are exclusively entitled to manufacture medicines. The manufacture of medicines does not mean the preparation of medicines for their dispensation in small quantities (Section 5) for a doctor's or veterinarian's prescription.
(2) The management of the manufacture of pharmaceuticals is the responsibility of the Ministry of Industry, with the exception referred to in paragraph 3. The Ministry of Health shall supervise the production and import of medicines, which shall in particular guarantee their value.
(3) The Ministry of Health may, in agreement with the Ministry of Finance, set up a national company for the production of biopreparations and adjust its legal status and internal organisation within the limits of the provisions of Section 4. the management of the production of these medicines belongs to the Ministry of Health.
(4) Detailed provisions for the implementation of paragraphs 1 and 2 shall be laid down by the Minister for Health in agreement with the Minister for Industry.
§ 3.
(1) The Ministry of Health organises and manages the distribution of all medicines. This distribution shall be carried out by a national undertaking which shall establish and adapt its legal status and internal organisation within the limits of the provisions of Section 4 of the Ministry of Health in agreement with the Ministry of Finance by a decree in the Official Journal.
(2) The national undertaking referred to in paragraph 1 shall include parts of the assets of the national undertakings serving or intended for the operation of wholesale trade in pharmaceuticals or for the operation of pharmacies, the property of the existing constitutional pharmacies of the State and of the Central National Insurance Corporation, as well as assets which are or are intended for the operation of pharmacies and which have been acquired by the State of confiscation or otherwise.
(3) The assets of the Central National Insurance Corporation, incorporated in the undertaking referred to in paragraph 1, are the property of the Central National Insurance Corporation. Article 8 to 10 of the Decree of the President of the Republic of 24 October 1945, No 100 Coll., concerning the nationalisation of mines and certain industrial enterprises, as amended by the Decree amending it, shall apply mutatis mutandis.
(4) The provisions of Sections 12, 5, 6 and 42 of the Decree shall apply mutatis mutandis to the integration of property confiscated under the decree of the President of the Republic of 25 October 1945, No 108 Coll., and to the confiscation of enemy assets and National Recovery Funds.
§ 4.
National undertakings set up pursuant to Articles 2, 3 and 3 (1) shall be subject to a proportion of the liabilities attributable to them as taken over; The Ministry of Health shall decide which obligations are to be transferred in agreement with the Ministry responsible. The provisions of Sections III and IV of the Decree shall apply mutatis mutandis to the legal status of those national undertakings, to the employment and pay ratios of their employees and to the exemption from taxes, duties and levies and to the provisions of Sections II to VII of the Act of 11 March 1948, No 51 Coll., on the adjustment of certain financial ratios of national industrial and food undertakings, as amended by the legislation amending it.

Část II.

Pharmacy.
§ 5.
(1) Small-scale medicinal products and their preparation for this purpose are reserved for pharmacies, unless otherwise specified.
(2) In addition to pharmacies, only medicinal products which are used for purposes other than medical treatment may be issued, provided that the Ministry of Health so provides in agreement with the ministries of internal trade and nutrition by decree in the Official Journal.
§ 6.
(1) The State operates pharmacies within the national enterprise set up under § 3.
(2) The authorisation to set up a pharmacy is granted by the Regional National Committee under the guidelines of the Ministry of Health, which contain the principles for the establishment of a network of pharmacies.
§ 7.
A pharmacy operated within a national enterprise (Section 6) must be personally managed by a responsible trustee who:
a) is a self-righteous Czechoslovak citizen,
b) has the rank of master of pharmacy in Czechoslovakia,
(c) has carried out professional activities for a period of at least 3 years following the acquisition of that grade; and
(d) is fit for proper personal management of the pharmacy.
Detailed regulations will be issued by the Minister for Health in agreement with the ministers involved.
§ 8.
(1) A physical person operating a pharmacy on 31 December 1949 may continue to operate it only if the conditions set out in Article 7 are fulfilled mutatis mutandis.
(2) The authorisation of a physical person to operate a pharmacy expires
(a) the death of the righteous,
(b) surrender of authorisation;
(c) withdrawal of authorisation.
(3) The Regional National Committee shall withdraw authorisation,
(a) where a change in the network of pharmacies requires this;
(b) if the creditor does not comply with one of the conditions laid down in § 7 (a) to (c),
(c) where the holder is permanently unfit for proper personal management of the pharmacy,
(d) if he has seriously infringed any of the provisions of this law or the provisions issued on its basis,
(e) where he has been prohibited from pursuing the pharmaceutical profession by an final judgment.
(4) In order to avoid the social hardships which could result from the implementation of paragraph 3 (c), the Minister for Health may, by regulation, provide for derogations from its provisions.
§ 9.
(1) In a pharmacy, each person must be given medicine according to the relevant rules if the buyer pays them in cash or if the medicine is to be issued according to the document submitted to the account of the Central National Insurance Company, the carrier of military sickness care or the carrier of care provided under the Act of 18 July 1946, No. 164 Coll., on care of military and war damages and victims of war and fascist persecution; without payment or presentation of the said document, it shall be issued only if the medical (veterinary) prescription shows a risk of delay.
(2) The Ministry of Health issues, changes and supplements, as appropriate, a pharmacopoeia which contains rules on the types, characteristics, preparation, storage and testing of medicinal products that may be issued at the pharmacy, those that must be permanently in storage at the pharmacy, as well as those which may be issued only on prescription. The Ministry of Health shall declare in the Official Journal when and where the pharmacopoeia was issued and when it takes effect.
(3) The pharmaceutical rate for medicines issued in pharmacies is determined in accordance with the general rules on price formation.
(4) In an agreement with the Ministry of Internal Trade, the Ministry of Health will determine in the Official Journal which medical, nursing and diagnostic supplies and other medical supplies may be issued in pharmacies and which may be issued in pharmacies only.
(5) The Minister for Health may entrust other tasks to pharmacies, which they are equipped to carry out because of the nature of their main task (§ 5).
§ 10.
(1) The Minister for Health will make provision for the operation of pharmacies by regulation.
(2) Direct supervision of pharmacies shall be carried out by the Regional National Committees; They shall be supervised by the Ministry of Health.
§ 11.
The right to operate a pharmacy shall not be carried or smuggled, nor shall it be subject to execution.

Část III.

Transitional provisions.
§ 12.
(1) Radiated and freely available pharmacies are no longer of this real nature. Their operators shall be assessed as other persons operating a pharmacy on the day on which this Law takes effect.
(2) The Library Court, acting on a proposal from the Regional National Committee, will transpose this law in the land register for the deletion of real law relating to the previously radiated pharmacy.
§ 13.
(1) The smelting ratio for which the authorisation to operate the pharmacy is subject shall cease. Paragraph 8 (4) shall apply mutatis mutandis.
(2) The execution of an authorisation for the operation of a pharmacy shall be revoked by the competent court of its own motion.
(3) The right to operate a pharmacy for which bankruptcy has been declared before the application of this law ceases to be part of the bankruptcy nature.
(4) Authorisations for the operation of existing branches of public pharmacies are no longer valid.
§ 14.
(1) The Ministry of Health shall, in agreement with the Ministry of Labour and Social Welfare and Agriculture, provide for a decree in the Official Journal, to what extent and under what conditions doctors and veterinary surgeons are required to have in stock, prepare and issue medicines. The day this decree comes into effect will be the day when the authorisation to operate the existing domestic (in Slovakia) pharmacies of doctors and vets expires.
(2) Medical and nursing institutes, amphibians of the Central National Insurance Corporation (its organisational units) and veterinary hospitals and hospitals are entitled to have in place for the needs of treated hand-held pharmaceuticals.
§ 15.
Where and if this is required by the proper supply of the workers with the necessary medicines and where the conditions for the establishment of the pharmacy are not met, medicines may also be issued in the manner set out in Section 210 (2) of the Act of 15 April 1948, No. 99 Coll., on national insurance. Paragraph 10 (2) shall apply mutatis mutandis.

Část IV.

Final provisions.
§ 16.
The acts and omissions which are contrary to the provisions of this law or to the provisions laid down under it shall be punishable, if not by a criminal offence, by a fine of up to 100.000 CZK or by a prison (lock-up) within 6 months or both. At the same time, in the event of non-availability of the fine, a replacement sentence shall be imposed at the rate of guilt within 6 months. If both sentences are imposed at the same time, the prison sentence (lockdown), together with the replacement sentence, must not exceed 6 months.
§ 17.
All measures under this Act, including supervision, or under the regulations issued under it, shall be made by the Ministry of Health in agreement with the Ministry of Agriculture with regard to medicinal products, medical, medical and diagnostic aids and other medical supplies for veterinary purposes. The supervision of the production of vaccines, sera and diagnostic biopreparations for veterinary medicine, produced in institutes or other establishments subject to the Ministry of Agriculture, shall belong to that Ministry.
§ 18.
(1) The validity of any provisions contrary to this law is hereby revoked, where applicable. in particular, the Law of 18 December 1906, No 5 of 1907 on the treatment of pharmaceuticals and the provisions of the XVI Chapter of Article XIV / 1876 on the organisation of public health.
(2) If the implementing provisions issued under this Act are not effective, the existing implementing provisions shall apply mutatis mutandis, unless they are contrary to its provisions; Where reference is made to criminal provisions referred to in paragraph 1, the provisions of Paragraph 16 shall apply.
§ 19.
The provisions of this Act shall not apply to pharmacies and equipment which they establish, operate and be supervised by the military administration for their own use.
§ 20.
This Act shall take effect on 1 January 1950; It shall be implemented by the Minister for Health in agreement with the participating members of the Government.
Gottwald v. r.
Dr John v. r.
Zaporocký v. r.
Plojhar v. r.

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Regulation Information

CitationAct No. 271 / 1949 Coll., on the Production and Distribution of Drugs
Regulation Type-
Author-
CollectionCode of Laws
Date of Promulgation29.12.1949
Effective from01.01.1950
Effective until-
Status Valid
The regulation text is for informational purposes only.
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