The Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993

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.