The Marketing Authorisations for Veterinary Medicinal Products Regulations 1994

Products manufactured outside the European Economic Area

7.—(1) Where a product to which a marketing authorisation relates is to be imported from outside the European Economic Area, the holder of that authorisation shall comply with article 27(c) of Council Directive 81/851/EEC and shall obtain an undertaking, given by the manufacturer of the product, that the manufacturer will comply with the provisions of this regulation.

(2) The manufacturer shall comply with any conditions attached to the authorisation.

(3) The manufacturer shall comply with the provisions of paragraphs (a), (b) (d) and (e) of article 27 of Council Directive 81/851/EEC.

(4) In accordance with article 35 of Council Directive 81/851/EEC, the manufacturer shall give to the Ministers on request the data specified in that article.

(5) Subject to the following paragraph, the manufactuerer shall comply with the principles and guidelines of good manufacturing practice as set out in articles 4 to 14 of Commission Directive 91/412/EEC, and such principles and guidelines shall be interpreted in accordance with article 3, second paragraph of that directive.

(6) In order to comply with the provisions of article 12 of Commission Directive 91/412/EEC, the manufacturer shall ensure that the terms of the contract require that the contractor complies with the requirements of article 12.3 and 12.4 of that directive.