Decree of the Ministry of Health of the Czech Socialist Republic No. 43 / 1987 Coll.
Decree of the Ministry of Health of the Czech Socialist Republic on the registration and reimbursement of mass-produced medicinal products
Valid
Effective from 01.07.1987
43
DECLARATION
Ministry of Health of the Czech Socialist Republic
of 7 May 1987
on the registration and reimbursement 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:
Subject matter of registration
(1) In order to ensure the production and import of medicines, (1) in particular in terms of their quality, efficiency and safety, in line with the current knowledge of medical science and the needs of health care, registration of mass-produced medicinal products is carried out. 1)
(2
(3) Registration of mass-produced medicinal products is decided by the Ministry of Health of the Czech Republic, in agreement with the Ministry of Agriculture and Nutrition of the Czech Republic.
(1) The following medicinal products manufactured in bulk and in uniform form (hereinafter referred to as "products") are subject to registration:
(a) simple and compound products intended to protect or restore health, to relieve disease symptoms or to affect physical functions in humans or animals, including dental and blood products;
(b) sera, vaccines and biological diagnostic preparations which come into contact with the human organism, the production, import and use of which is subject to the approval of the chief hygienist of the Czech Socialist Republic;
(c) diagnostic preparations and disinfectants which come into contact with a human or animal organism;
(d) products of synthetic polymers and high molecular organic compounds intended for short or long term contact with human or animal organisms (e.g. as carriers of medicinal products, surgical suture material),
(e) veterinary biopreparations for which the Ministry of Agriculture and Nutrition of the Czech Republic is responsible for production and distribution.
(2) Registration shall not be subject to:
(a) products imported in a maximum of five packages or for an individual patient per treatment course, products imported as samples solely for the special purpose of scientific, research and control institutes or preventive treatment, and gift consignments of products sent from abroad directly to the address of the patient or keeper of the animal;
(b) cosmetic products where the composition of the active substances should not include them in the preparation;
(c) disinfectant, disinfectant and exterminator products intended for use other than in humans or animals.
Application for registration
(1) The application for authorisation (individually for each of its pharmaceutical forms) is submitted by the manufacturer. The application, including supporting documents, shall be lodged at least in duplicate with the State Institute for Drug Control, 2) which shall process and prepare the evidence for the registration of medicinal products. If the manufacturer does not have its registered office in the territory of the Czechoslovak Socialist Republic, the application for registration of the product on his behalf is submitted by the branch of the Health Supply Company in Prague, or by another organisation designated for that purpose by the Ministry of Health of the Czech Socialist Republic (hereinafter referred to as the Ministry).
(2) The application for authorisation of a product shall contain the following particulars and supporting documents:
(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, for veterinary products, including the species of animals for which it is intended;
(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 and secondary (auxiliary) substances must be indicated by the correct chemical, generic or international names,
(d) indications and contraindications for the use of the product, or interactions with the concomitant use of other products and known adverse reactions;
(e) the technical documentation of the manufacturer containing the complete test rules and technical literature on the testing of the preparation, including a quantity of samples sufficient to carry out at least three complete analyses according to the documentation submitted;
(f) detailed reports on the results of the pharmacological and / or immunopharmacological and immunological, 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 data on the adverse effects of the products;
(g) in the case of veterinary products, particulars of the presence of residues in the organism and of livestock products as well as of the withdrawal periods after which those products may be used in human nutrition;
(h) the expiry date of the product as documented by the stability study.
(3) The manufacturer shall attach two samples of the final preparation of the preparation, including package leaflet and promotional material.
(4) If the application for registration does not have the required formalities, the Ministry shall invite the applicant to remove it within the prescribed time limit and shall also instruct the applicant how important it may be not to remedy the deficiencies in the proceeding. 3)
Control of products
Products for which registration is requested shall be subjected to laboratory and, where appropriate, clinical examination at clinical or other health centres. These workplaces are determined by the Ministry; the Ministry of Agriculture and Nutrition of the Czech Socialist Republic.
Marketing Authorisation
(1) At the end of the registration procedure, the Ministry of the Marketing Authorisation shall issue a marketing authorisation if it finds out all the particulars referred to in Section 3; it shall do so for veterinary products after prior approval by the Ministry of Agriculture and Nutrition of the Czech Republic. On the basis of a marketing authorisation issued, the Ministry shall register the product.
(2) The marketing authorisation is valid for five years from the time of the marketing authorisation. The Ministry shall draw the attention of the applicant to this fact one year before the expiry date of the registration.
(3) The register is kept by the Ministry.
(4) Registration, renewal and erasure of registration are published in the Ministry Bulletin.
Deleting registration
(1) The Ministry decides to cancel the marketing authorisation of the product
(a) if the manufacturer of the registered product so requests,
(b) if serious adverse reactions or other properties not in accordance with the marketing authorisation decision given are identified,
(c) if it is found that the authorisation resulting from registration has been misused,
(d) if the manufacturer of the registered product does not request an extension of the marketing authorisation until six months before the expiry of the marketing authorisation.
(2) For veterinary products, they will do so after prior approval by the Ministry of Agriculture and Nutrition of the Czech Republic.
Reimbursement of registration costs
(1) The reimbursement of the costs of registration shall be fixed at a flat-rate amount and shall be charged to the registrant.
(2) The flat-rate amount includes the costs of drawing up expert Opponent opinions on the supporting documents submitted, the costs of routine laboratory inspection and the use of equipment and materials in its implementation.
(1) The flat-rate reimbursement of costs per product (one pharmaceutical form) is:
| za registraci přípravku | 2000 Kčs, |
| za prodloužení registrace | 1000 Kčs. |
(2) Where an application for registration or extension is submitted on behalf of a foreign manufacturer by a health supply company or another organisation designated by the Ministry, the flat-rate payment shall be increased by the amount of Kčs 300.
In addition to the lump sum provided for in Section 10, the costs of any clinical examination of the product or its special laboratory inspection may also be charged to the registrant in special cases.
Final provision
The Ministry may authorise the importation and use of a product for exceptional import purposes without prior registration. 4) For exceptional import of veterinary medicinal products after prior approval of the Ministry of Agriculture and Nutrition of the Czech Republic.
They shall be deleted:
a) Decree of the Ministry of Health of the Czech Socialist Republic No. 81 / 1969 Coll., on the registration of mass-produced medicinal products,
(b) Directive No. 14 / 1984 of the Ministry of Health of the Czech Socialist Republic MZ ČSR on reimbursement of costs associated with the registration of a mass-produced medicinal product (register in amount of 22 / 1984 Coll.).
This Decree shall take effect on 1 July 1987.
Minister:
Prof. MUDr. Prohlo, CSc., Rev.
1) The definition of "medicine" and "mass-produced medicinal product" is given in the Czechoslovak Pharmacopoeia - 4th edition, whose binding obligation in the Czech Socialist Republic is established by Decree of the Ministry of Health of ČSR No. 10 / 1987 Coll.
2) Article 11 of the Statute of the State Institute for Drug Control No 3 / 1982 MZ ČSR.
3) Paragraph 19 (3) of Act No. 71 / 1967 Coll., on Administrative Procedure (Administrative Regulation).
4) Paragraphs 20 (2) and 62 (1) of Act No. 20 / 1966 Coll., on the care of the health of the people.
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Regulation Information
| Citation | Decree of the Ministry of Health of the Czech Socialist Republic No. 43 / 1987 Coll., on the registration of mass-produced medicinal products and the reimbursement of the costs associated with it |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 25.05.1987 |
|---|---|
| Effective from | 01.07.1987 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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