Article 12

Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products · European Union

1. If several applications submitted in accordance with Article 4 of Directive 65/65/EEC have been made for marketing authorization for a particular proprietary medicinal product, and one or more Member States have granted an authorization while one or more of the other Member States have refused it, one of the Member States concerned may bring the matter before the Committee. The same shall apply where one or more Member States have suspended or revoked the marketing authorization while one or more other Member States have not done so. 2. The Committee shall consider the matter and give a reasoned opinion within 120 days at the most. 3. The opinion of the Committee shall only deal with the grounds on which authorization was refused, suspended or revoked. The Committee shall forthwith inform the Member States concerned of its opinion or, in the event of a divergence, of the opinions of its members. 4. The Member States concerned shall give notice within 30 days of the action they intend to take following the Committee's opinion.

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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.