Article 19

Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products · European Union

1. In the cases referred to in Article 18 (2), the Committee shall consider the matter and shall deliver its reasoned opinion within 60 days from the expiry of the time limit laid down in Article 18. 2. The opinion of the Committee shall deal with the compliance of the veterinary medicinal product with the conditions set out in Article 11. The Committee shall forthwith inform the Member States concerned of its opinion or, in the event of dissension, of the opinions of its members. 3. The Member States concerned shall reach a decision on the application for marketing authorization not later than 30 days after the date on which the information provided for in Article 18 (1) or paragraph 2 hereof is given. They shall forthwith inform the Committee of their decision.

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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.