Regulation No 37 / 1950 Coll.
Regulation on the security of the production and import of valuable medicines
Valid
Effective from 20.04.1950
37.
Regulation of the Minister for Health
of 6 April 1950
on the security of the production and import of valuable medicines.
In agreement with the Minister of Industry pursuant to § 2 (4) of Act No. 271 / 1949 Coll., on the production and distribution of pharmaceuticals:
General provisions.
In order to ensure the production and import of valuable medicines,
(a) when drawing up a production and import plan in the field of pharmaceuticals, account shall be taken of the need for medicines (Section 2);
(b) as a general rule, only those types of mass-produced drugs that are included in the schedule of the need for medicines can be produced and imported (Sections 3 to 10); and
(c) the quality of medicines is checked (§ 11 to 15).
The plan for the need for medicines (hereinafter referred to as the plan) shall be drawn up by the Ministry of Health for each year.
Mass-produced drugs.
(1) Except as provided for in Section 7, only those types of mass-produced drugs included in the plan are permitted to be produced and imported.
(2) The mass-produced medicines are simple or composite drugs in finished form and in uniform presentation. Simple or composite diagnostic products and disinfectants used in the course of medical care, provided they are in finished form and in uniform form, shall also be considered mass-produced under this Regulation.
The Ministry of Health will include a mass-produced drug in the plan if, according to the current state of science, there is evidence of medicinal effects and if it is needed to provide health care. It shall take into account in particular whether the mass-produced drug overtakes the medicinal effect, stability or other properties of the medicinal product prepared at the pharmacy, or whether the mass-produced drug constitutes an economic or facilitate the supply of the medicinal product.
(1) The Ministry of Health decides to include a mass-produced drug in a proposal or from an official authority.
(2) A proposal for the inclusion of a mass-produced drug may be made by:
(a) the manufacturer, if it is a national drug,
(b) the importer, if it is a medicine manufactured abroad.
(3) The proposal referred to in paragraph 2 shall specify:
(a) the indication under which the medicinal product is to be put into circulation; if the medicine is marked with a trade mark, proof of its registration shall be attached;
(b) the exact composition of the drug as a percentage of the weight, after the content of the active substances expressed by biological units in one cubic centimetre or per dose (piece);
(c) a clinical opinion on the efficacy of the medicinal product or on the professional literature on the medicinal effects of its active substances;
(d) a prescription for checking the quantity and quality of active substances or for biological efficiency or for professional literature.
(4) The design referred to in paragraph 2 shall be accompanied by one sample of the medicinal product in an interim package containing the text of the package and, where appropriate, by additional samples and material for the examination. Where a medicinal product is manufactured in a foreign State in which the manufacture and sale of medicinal products are subject to an authorisation procedure, proof shall also be provided that the manufacture and sale of the medicinal product has been authorised in that State or that the medicinal product is put into circulation in a foreign State.
If the public health interest so requires, the Ministry of Health may impose conditions on the inclusion of a mass-produced drug in the plan.
(1) In cases of special consideration, the Ministry of Health may, with the agreement of the Ministry of Health, also produce or import types of mass-produced medicines not included in the plan.
(2) Paragraph 4 to 6 shall apply mutatis mutandis to the consent referred to in paragraph 1.
The mass-produced drugs may only be put into circulation with the labelling, composition, dosage and presentation as included in the plan, or their production and import authorised. The Ministry of Health may allow derogations from the provisions of the first sentence.
If under the general legislation another person is not responsible, he / she shall be responsible for the contents, quality and presentation of the package of the mass-produced drug
(a) the manufacturer, if it is a domestic medicine,
(b) the importer, if it is a foreign medicine.
The Ministry of Health may, for health or economic reasons, release a mass-produced drug from the plan and, in urgent cases, prohibit its putting into circulation.
Drug control.
(1) In addition to the quality control of pharmaceuticals carried out by national drug manufacturing companies, the national drug distribution company and pharmacies, the quality of all pharmaceuticals is also controlled by the state health administration.
(2) The State Health Administration controls
(a) in particular the quality of medicinal products for which biological control is required in the national drug manufacturing undertakings and medicinal products for which defects have been detected in the control of the bulk components of the national drug distribution undertaking or in pharmacies;
(b) in the wholesale components of the national drug distribution undertaking, the quality of the medicines sold; and
(c) in pharmacies, in particular, the quality of medicines prepared under the veterinary prescription.
(1) The Ministry of Health shall carry out the control of pharmaceuticals in the national drug manufacturing undertakings and in the wholesale components of the national drug distribution undertaking, by its own authorities, the State Health Institute or other authorities of the State Health Administration, which shall entrust this control.
(2) The rules on the inspection of pharmacies apply for the control of pharmaceuticals.
(1) The authorities of the State Health Administration carrying out the control of medicinal products referred to in Article 12 (1) are entitled to withdraw samples of medicinal products in the quantities necessary for their examination. Samples shall be taken on behalf of the manufacturer, if they are domestic or the importer, if they are foreign.
(2) In order to ensure the timely control of the medicinal products referred to in Article 12 (1), the Ministry of Health may require national pharmaceuticals manufacturing undertakings and national drug distribution undertakings to send lists and samples of pharmaceuticals produced or imported to the State Health Institute at regular intervals.
The authorities of the State Health Administration carrying out the control of medicinal products referred to in Article 12 (1) shall ensure that the performance of the control does not interfere with the operation of the undertakings and shall also be obliged to keep the confidentiality of production secrets provided that they are informed when carrying out the inspection. The obligation to remain silent does not cease to exist by the person who carried out the control of the medicinal products.
The Ministry of Health shall prohibit the further production or putting into circulation of defective production series if the checks carried out prove necessary.
Transitional and final provisions.
The mass-produced drugs whose manufacture and sale has been authorised under Government Regulation No. 26 / 1926 Coll., on the production and trade of medicinal specialities in pharmacies but not included in the 1950 Plan, shall be prohibited from further manufacture or import.
All measures under this Regulation concerning medicinal products, medical, medical and diagnostic devices and other veterinary medical needs, including supervision of their production and distribution, shall be taken by the Ministry of Health in agreement with the Ministry of Agriculture.
The proceedings and omissions which are contrary to the provisions of this Regulation are punishable by Article 16 of Act No. 271 / 1949 Coll.
This Regulation shall enter into force on the day of its publication.
Zaporocký v. r.
Plojhar v. r.
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Regulation Information
| Citation | Regulation No. 37 / 1950 Coll., on the security of the production and import of valuable medicines |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 20.04.1950 |
|---|---|
| Effective from | 20.04.1950 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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