Decree of the Ministry of Health of the Slovak Socialist Republic No. 102 / 1969 Coll.
Decree of the Ministry of Health of the Slovak Socialist Republic on the registration of mass-produced medicinal products
Valid
Effective from 01.09.1969
102
DECLARATION
Ministry of Health of the Slovak Socialist Republic
of 30 July 1969
on the authorisation of mass-produced medicinal products
The Ministry of Health of the Slovak Socialist Republic provides in agreement with the Ministry of Agriculture and Nutrition and the Ministry of Finance of the Slovak Socialist Republic pursuant to § 20 (2), § 62 (1) and § 70 (1) (c) of Act No. 20 / 1966 Coll., on the care of the health of the people:
(1) In order to ensure the production and import of medicines in accordance with the current knowledge of medical science and the needs of health care, registration of mass-produced medicinal products is hereby established.
(2
(1) The following medicinal products manufactured in bulk in finished form and in uniform presentation (hereinafter referred to as "products") are subject to registration:
(a) simple and compound preparations intended for the protection or restoration of health, for the relief of disease symptoms, for affecting physiological functions in humans or animals, including dental preparations, blood preparations and veterinary biopreparations, the production, distribution and import of which are under the supervision of the Ministry of Agriculture and Nutrition of the Slovak Socialist Republic;
(b) diagnostic preparations and disinfectants which come into contact with a human or animal organism.
(2) Registration shall not be subject to:
(a) sera, vaccines and biological diagnostic preparations for which the main hygienist of the Slovak Socialist Republic has given his consent to manufacture, import and use;
(b) products imported in small quantities, products imported as samples for the sole purpose of the particular need of scientific, research and control organisations and institutes or facilities of preventive care and gift consignments of products sent from abroad directly to the address of the patient.
The application for marketing authorisation shall be submitted by the manufacturer to the Ministry of Health of the Slovak Socialist Republic (hereinafter referred to as the Ministry). If the manufacturer is not established in the territory of the Czechoslovak Socialist Republic, he shall submit an application for registration of the product on his behalf of the Medical Supplies, n., Bratislava, or the organisation designated by the Ministry.
The application for marketing authorisation shall include in particular:
(a) the name and address of the manufacturer and proof of his business authorisation;
(b) the label under which the product will be put into circulation, indicating the package size and the form of application;
(c) the composition of the preparation in precise weight or volume data and, where appropriate, the number of biological units per quantity unit; all main active or auxiliary substances shall be indicated by the correct chemical, generic and international names and drawings of the chemical formulas;
(d) indications and contraindications for use of the product,
(e) the manufacturer's technical documentation containing the complete test rules and technical literature on the testing of the preparation, including a quantity of samples sufficient for at least three complete analyses according to the documentation submitted;
(f) a detailed report on the results of the pharmacological, toxicological and clinical trials of the product, including the manufacturer's clinical documentation, indicating the name, profession and address of the test staff and the particulars of the side effects of the product;
(g) two samples of the preparation, including a package leaflet and promotional material.
(1) The products for which registration is requested are subject to laboratory and, where appropriate, clinical examination at clinical or research centres. This workplace is determined by the Ministry, for veterinary products in agreement with the Ministry of Agriculture and Nutrition of the Slovak Socialist Republic.
(2) The costs of registration, including the costs of laboratory and clinical inspection, are borne by the applicant.
(1) At the end of the registration procedure, the Ministry of Marketing Authorisation will issue veterinary products in agreement with the Ministry of Agriculture and Nutrition of the Slovak Socialist Republic. In the absence of evidence in the registration procedure to prevent registration, the Ministry shall at the same time authorise the registration of the product by this decision.
(2) Entry into the register is valid for five years from the date of the marketing authorisation. The validity of the registration may be extended by the Ministry if requested by the owner of the product registration number.
(1) The Ministry shall decide to cancel the registration even before the expiry of the period referred to in Article 6 (2):
(a) where the owner of the product registration number so requests,
(b) if adverse reactions or other non-compliant properties are identified with the product,
(c) if it is found that the authorisation resulting from the registration has been misused.
(2) For veterinary products, the Ministry will decide to cancel the registration in agreement with the Ministry of Agriculture and Nutrition of the Slovak Socialist Republic.
(1) The register is kept by the Ministry.
(2) The entries in the register, the renewal of the registration and its revocation are published in the Ministry Bulletin.
Registration of products under this Decree replaces the authorisation for the use of medicines and the approval of medicines under Sections 20 (2) and 62 (1) of Act No. 20 / 1966 Coll.
(1) The registration of domestic products whose production and use were authorised by the Ministry of Health of the Czechoslovak Socialist Republic before the entry into force of this Decree will be carried out by official authority.
(2) Registration of foreign products included in the Ministry's import plan for 1969 and 1970 will be carried out by the Ministry upon request in accordance with the second sentence of Section 3. The documents referred to in Paragraph 4, except for the documents referred to in (e), need not be submitted. The application shall be submitted within 3 months of the effective date of the order.
The Ministry may allow exemptions from the provisions of this Decree in cases of extremely important importance.
This decree shall take effect on 1 September 1969.
Minister:
Dr Zvara v. r.
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Regulation Information
| Citation | Decree of the Ministry of Health of the Slovak Socialist Republic No. 102 / 1969 Coll., on the registration of mass-produced medicinal products |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 27.08.1969 |
|---|---|
| Effective from | 01.09.1969 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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