Title and commencement
1. These Regulations may be cited as the Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993 and shall come into force on 29th October 1993.
2.—(1) In these Regulations—
“the Act” means the Medicines Act 1968;
“application” means a request for the grant of a product licence and shall comprise all the documents submitted in support of it, and “applicant” shall be construed accordingly;
“Directive 81/852” means Council Directive 81/852/EEC on 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 products(3) amended by Council Directive 87/20/EEC(4) and Commission Directive 92/18/EEC(5);
“Directive 90/677” means Council Directive 90/677/EEC extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products(6);
“immunological product” means a veterinary medicinal product used in order to produce active or passive immunity or to diagnose the state of immunity, to which Directives 81/851 and 90/677 apply;
“product licence” means a product licence in relation to a veterinary medicinal product to which Directive 81/851 applies;
“standard provisions for licences” means the relevant standard provisions prescribed by regulations under section 47(1) of the Act(7); and
“veterinary medicinal product” has the meaning assigned to that expression in Directive 81/851 and for the purposes of these Regulations shall be treated as a medicinal product within the meaning of section 130 of the Act.
(2) In these Regulations any reference to a numbered regulation or Schedule shall be construed as a reference to the regulation or Schedule so numbered in these Regulations.
Form and manner of application
3.—(1) Every application shall be made in writing in the English language and shall be signed by the applicant.
(2) The applicant shall supply to the licensing authority four copies of each application, and shall supply a further twenty-two copies if the licensing authority so directs.
(3) Where the application, or any part thereof, has been translated from another language, the applicant shall supply to the licensing authority one copy of such application or part, as the case may be, in the original language if the licensing authority so directs.
Requirements as to application
4.—(1) Subject to paragraphs (2) and (3) below, an applicant for a product licence shall submit to the licensing authority the particulars and documents required by Articles 5 and 5a of Directive 81/851 and—
(a)if the application is in respect of a veterinary medicinal product other than an immunological product, shall comply with the requirements set out in Schedule 1, or
(b)if the application is in respect of a veterinary medicinal product which is an immunological product, shall comply with the provisions of Article 2 of Directive 90/677 and the requirements set out in Schedule 2.
(2) An applicant shall not be required, by virtue of paragraph 10 of Article 5 of Directive 81/851, to provide the results of toxicological and pharmacological tests and clinical trials if he can demonstrate that he is entitled, subject to the provisions of that paragraph, to the benefit of any of sub-paragraphs (a)(i) to (iii) thereof.
(3) Paragraph (2) above shall not apply where the applicant claims the benefit of Article 5.10(a)(iii) of Directive 81/851, unless the product authorised within the European Economic 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.
Supplementary provisions as to application
5.—(1) The applicant shall in making his application—
(a)take account of the guidance published by the European Commission referred to in the first paragraph of the Introduction to the Annex to Directive 81/852, and
(b)include all information relevant to the evaluation of the product to which the application relates, whether favourable or unfavourable, including all relevant details of any incomplete or abandoned test or trial relating to the product,
and shall confirm in writing that he has done so.
(2) The applicant shall confirm in writing that he has complied with the requirements of the Animals (Scientific Procedures) Act 1986(8) which are relevant to his application.
(3) The applicant shall state which, if any, of the standard provisions for licences it is desired shall be excluded or modified in relation to any product licence granted as a result of the application.
(4) The licensing authority may require the applicant to submit such samples as they may specify—
(a)of the veterinary medicinal product, its active ingredients and its intermediate products or other constituent materials for testing by a laboratory designated for the purposes of Article 9.2 of Directive 81/851, in order to ensure that the applicant’s control testing methods within the meaning of Article 5.9 of that Directive are satisfactory, or
(b)of substances necessary to verify the analytical detection methods to trace residues proposed in the application documents in pursuance of Article 5.8 of that Directive.
6. The Regulations set out in Schedule 3 are hereby revoked in so far as they relate to applications for product licences for veterinary medicinal products.
Parliamentary Under Secretary of State,
Department of Health
21st September 1993
Parliamentary Under Secretary of State, Scottish Office
21st September 1993
Secretary of State for Wales
24th September 1993
In witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on
Minister of Agriculture, Fisheries and Food
20th September 1993.
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this
F. A. Elliott
23rd day of September 1993.
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this
W. J. Hodges
30th day of September 1993.