Marketing Authorisations for Veterinary Medicinal Products Regulations 1994
| Jurisdiction | UK Non-devolved |
| Citation | SI 1994/3142 |
1994 No. 3142
MEDICINES
The Marketing Authorisations for Veterinary Medicinal Products Regulations 1994
Made 5th December 1994
Laid before Parliament 9th December 1994
Coming into force 1st January 1995
The Minister of Agriculture, Fisheries and Food and the Secretary of State, being Ministers designated1for the purposes of section 2(2) of the European Communities Act 19722in relation to medicinal products, acting jointly, in exercise of the powers conferred on them by the said section 2(2), hereby make the following Regulations:
Title, commencement and interpretation
1.—(1) These Regulations, which implement parts of:
Council Directive 81/851/EECon the approximation of the laws of the Member States relating to veterinary medicinal products3;
Council Directive 81/852/EECon the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products4;
Council Directive 90/676/EECamending Directive 81/851/EECon the approximation of the laws of the Member States relating to veterinary medicinal products5;
Council Directive 90/677/EECextending the scope of Directive 81/851/EECon the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products6;
Commission Directive 91/412/EEClaying down the principles and guidelines of good manufacturing practice for veterinary medicinal products7;
Commission Directive 92/18/EECmodifying the Annex to Council Directive 81/852/EEC8;
Council Directive 92/74/EECwidening the scope of Directive 81/851/EECon the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products9;
Council Regulation 2309/93/EEC laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products10; and
Council Directive 93/40/EECamending Directives 81/851/EECand 81/852/ EEC on the approximation of the laws of the Member States relating to veterinary medicinal products11;
may be cited as the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 and shall come into force on 1st January 1995.
(2) These Regulations shall apply in respect of products to which Council Directive 81/851/EECapplies by virtue of article 2 of that directive, including products intended for the uses set out in article 3 of that directive, but do not apply to products specified in article 1.3 or 1.4 of Council Directive 90/677/EEC.
(3) These Regulations shall apply to homeopathic veterinary medicinal products other than those specified in article 7 of Council Directive 92/74/EEC.
(4) In these Regulations, unless the context otherwise requires, any expressions used have the meaning they bear in Council Directives 81/851/EECand 90/677/EECand Council Regulation 2309/93/EEC;
“the appropriate committee” has the meaning assigned by section 4(6) of the Medicines Act 196812;
“the commission” means the Medicines Commission established by the Medicines Act 1968;
“marketing authorisation” means an authorisation to place on the market a veterinary medicinal product to which these Regulations apply;
“the Ministers” means the Minister of Agriculture, Fisheries and Food, the Secretary of State concerned with health in England and the Secretaries of State for Wales and Scotland, the Department of Agriculture for Northern Ireland and the Department of Health and Social Services for Northern Ireland.
(5) Any function conferred on the Ministers under these Regulations may be performed by any one of those Ministers acting alone or by any two or more of them acting jointly.
(6) Any reference in these Regulations to a directive is to that directive as amended.
Circumstances in which these Regulations do not apply
2.—(1) These Regulations shall not apply to the placing on the market of veterinary medicinal products prepared extemporaneously in the circumstances described in article 4.4(c) of Council Directive 81/851/EEC.
(2) These Regulations shall not apply to the placing on the market of veterinary medicinal products under sections 32 to 39 of the Medicines Act 1968.
(3) These Regulations shall not apply to any product which by virtue of regulation 19(1) below continues to have a product licence under section 7 of the Medicines Act 1968 so long as that licence remains in force.
Placing veterinary medicinal products on the market
3. No person shall place on the market, or have in his possession for the purposes of placing on the market, any veterinary medicinal product unless a marketing authorisation (or, in the circumstances described in article 4.1, third paragraph of Council Directive 81/ 851/EEC, an allowance within the terms of that paragraph) has been granted—
(a) by the Ministers, or
(b) in accordance with Council Regulation 2309/93/EEC,
and it is placed on the market in accordance with such authorisation or allowance.
Form and manner of application
4.—(1) Every application for a marketing authorisation by the Ministers shall be made to them in accordance with this regulation.
(2) The application shall be in writing, in the English language and signed by the applicant.
(3) The applicant shall supply four copies of each application, and shall supply a further twenty-two copies if the Ministers so direct.
(4) The application shall be—
(a)
(a) as specified in articles 5, 5a, 6 and 7 of Council Directive 81/851/EEC(or, in the case of an application for authorisation of a product already authorised in another member State, may be in accordance with article 17 of that directive) and in accordance with the Introduction to the Annex to Council Directive 81/ 852/EEC, or
(b)
(b) in the circumstances described in article 15.2 of Council Directive 81/851/EEC, shall be accompanied by all relevant data available to the applicant.
(5) If the application is in respect of a product which is not an immunological product the application shall in addition be in accordance with the requirements of Schedule 1 to these Regulations.
(6) If the application is in respect of an immunological product, the application shall in addition be in accordance with the provisions of article 2 of Council Directive 90/677/ EEC and the requirements of Schedule 2 to these Regulations.
(7) In the case of a product which the applicant intends to import from outside the European Economic Area, the application shall in addition be in accordance with article 25 of Council Directive 81/851/EEC.
(8) An applicant shall not be required, by virtue of paragraph 10 of article 5 of Council Directive 81/851/EEC, to provide the results of toxicological and pharmacological tests and clinical trials if he can demonstrate that he is entitled to the benefit of any of sub-paragraphs (a)(i) to (iii) thereof.
(9) The preceding paragraph shall not apply where the applicant claims the benefit of article 5.10(a)(iii) of Council Directive 81/851/EEC, unless the product authorised within the European Community to which the applicant refers has been so authorised for a period of not less than ten years before the making of the application.
Grant of an authorisation
5. The Ministers shall consider an application for, and where appropriate grant, a marketing authorisation for a veterinary medicinal product—
(a) in accordance with articles 4.2, 5b, 8 to 11, 15, 36.3, 40, 41, 42.1 and 43 of Council Directive 81/851/EEC, and, as appropriate, in accordance with article 12 of that directive and Title I, Part 4, Chapter II. 1, sixth paragraph of the Annex to Council Directive 81/852/EEC, or
(b) in the case of a product already authorised in another member State, in accordance with article 4.1, second paragraph, or articles 4.2, 8, 8a, 40 and 41 and Chapter IV of Council Directive 81/851/EEC,
and in both cases, where appropriate, in accordance with article 4 of Council Directive 90/677/EEC.
Duties on persons responsible for placing products on the market
6.—(1) After a marketing authorisation has been issued, the person responsible for placing a veterinary medicinal product on the market shall comply with:
(a)
(a) articles 5.2.13, 14, 15, 42.2, 42c, 42d and 43 to 48 of Council Directive 81/851/ EEC;
(b)
(b) the third paragraph of the introduction to the Annex to Council Directive 81/ 852/EEC and, if appropriate, the final paragraph of Title I, Part 4, Chapter II.1 and the final paragraph of Title I, Part 4, Chapter III, 2.1 of Council Directive 81/852/EEC;
(c)
(c) if appropriate, articles 2 and 3 of Council Directive 90/677/EEC;
(d)
(d) any direction given by the Ministers in accordance with article 37 of Council Directive 81/851/EEC; and
(e)
(e) the requirement in article 35 of Council Directive 81/851/EECto provide the data specified in that article.
(2) In addition to the requirements in the provisions referred to in the preceding paragraph relating to information to be provided on labels and package inserts, the holder of a marketing authorisation shall ensure that labels and package inserts—
(a)
(a) include the words “store out of reach of children”;
(b)
(b) include the following initials in a box within which there is no other written material:
(i) in the case of a product categorised under the Medicines Act 1968 as a medicinal product on prescription only (that is, a prescription only medicine), the capital letters “POM”;
(ii) in the case of a product categorised under that Act as a Pharmacy...
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