Regulation 4 Form and manner of application
Every application for a marketing authorisation by the Ministers shall be made to them in accordance with this regulation.
The application shall be in writing, in the English language and signed by the applicant.
The applicant shall supply four copies of each application, and shall supply a further twenty-two copies if the Ministers so direct.
The application shall be—
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
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.
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.
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.
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.
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.
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.