Decree of the Ministry of Health of the Czech Socialist Republic No. 81 / 1969 Coll.
Decree of the Ministry of Health of the Czech Socialist Republic on the registration of mass-produced medicinal products
Valid
Effective from 01.09.1969
81
DECLARATION
Ministry of Health of the Czech Socialist Republic
of 7 July 1969
on the authorisation of mass-produced medicinal products
The Ministry of Health of the Czech Socialist Republic provides, in an agreement with the Ministry of Agriculture and Nutrition of the Czech Socialist Republic and with other participating bodies pursuant to § 70 (1) (c) of Act No. 20 / 1966 Coll., on the care of the health of the people, for the implementation of § 20 (2) and § 62 of the same Act:
(1) In order to ensure the production and import of medicinal products in accordance with the current knowledge of medical science and the needs of health care, a registration of mass-produced medicinal products is introduced
(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 composite products intended to protect or restore health, to relieve disease symptoms or to influence physiological functions in humans or animals, including dental products, blood products and veterinary biopreparations, the production, distribution and import of which are subject to surveillance by the Ministry of Agriculture and Nutrition;
(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 chief hygienist of the Czech 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 institutes or treatment facilities, 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; the application shall be submitted to the Ministry of Health. If the manufacturer does not have its registered office in the territory of the Czechoslovak Socialist Republic, he shall submit an application for registration of the product on his behalf to the health supply industry in Prague or to an organisation designated by the Ministry of Health.
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 indication of the product under which it 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 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 product, including such quantity of the sample as is sufficient to carry out 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 packaging, including the package leaflet and promotional material.
(1) The products for which registration is sought are subject to laboratory control and, where appropriate, clinical control at clinical or research centres. These workplaces are determined by the Ministry of Health; for veterinary products, it does so in agreement with the Ministry of Agriculture and Nutrition.
(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 Health will issue a marketing authorisation; for veterinary products, they shall do so in agreement with the Ministry of Agriculture and Nutrition. A marketing authorisation shall be made subject to registration.
(2) Entry into the register is valid for five years from the date of the marketing authorisation.
The Ministry of Health decides to delete the registration of the product from the register,
(a) where the owner of the product registration number so requests,
(b) if adverse reactions or other non-compliant properties are identified for the product,
(c) if it is found that the authorisation resulting from registration has been misused,
(d) unless the holder of the marketing authorisation number requests an extension of the marketing authorisation.
For veterinary products, they will do so in agreement with the Ministry of Agriculture and Nutrition.
(1) The register is headed by the Ministry of Health.
(2) The entries in the register, the extension of registration and the deletion of entries are published in the Ministry of Health 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 import plan of the Ministry of Health for the years 1969 and 1970 will be carried out by the Ministry of Health upon request in accordance with the second sentence of Section 3. In this case, the documents referred to in Section 4 need not be submitted except for the documents provided for under point (e) of this paragraph. The application must be submitted within 3 months of the date of entry into force of the Order.
The Ministry of Health may allow exemptions from the provisions of this Decree in exceptional circumstances.
This Decree shall take effect on 1 September 1969.
Minister:
Dr Wolček v. r.
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Regulation Information
| Citation | Decree of the Ministry of Health of the Czech Socialist Republic No. 81 / 1969 Coll., on the registration of mass-produced medicinal products |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 21.07.1969 |
|---|---|
| Effective from | 01.09.1969 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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