Article 37

1. After an authorization has been issued in accordance with this Regulation, the person responsible for placing the veterinary medicinal product on the market shall, in respect of the methods of production and control provided for in points 4 and 9 of the second paragraph of Article 5 of Directive 81/851/EEC, take account of technical and scientific progress and make changes that may be required to enable the veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods. The aforementioned person must apply for approval for these changes in accordance with this Regulation. Upon a request from the Commission, the person responsible for placing the veterinary medicinal product on the market shall also review the analytical detection methods provided for in point 8 of the second paragraph of Article 5 of Directive 81/851/EEC and propose any changes which may be necessary to take account of technical and scientific progress. 2. The person responsible for placing the veterinary medicinal product on the market shall forthwith inform the Agency, the Commission and the Member States of any new information which might entail the amendment of the particulars and documents referred to in Articles 28 and 31 or in the approved summary of the product characteristics. In particular the aforementioned person shall forthwith inform the Agency, the Commission and the Member States of any prohibition or restriction imposed by the competent authorities of any country in which the veterinary medicinal product is marketed and of any other new information which might influence the evaluation of the benefits and risks of the veterinary medicinal product concerned. 3. If the person responsible for placing the veterinary medicinal product on the market proposes to make any alteration to the information and particulars referred to in Articles 28 and 31, he shall submit an application to the Agency. 4. The Commission shall, in consultation with the Agency, adopt appropriate arrangements for the examination of variations to the terms of a marketing authorization. These arrangements shall include a notification system or administrative procedures concerning minor variations and define precisely the concept of 'a minor variation'. These arrangements shall be adopted by the Commission in the form of an implementing Regulation in accordance with the procedure laid down in Article 72.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.