Article 10

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, within a period of 120 days after the date of the forwarding referred to in Article 9 (2), no objection is notified to the Committee by the competent authorities of the Member States specified, the Committee shall formally record the fact and forthwith inform the Member States concerned. 2. Where a Member State considers that it is unable to authorize the marketing of the proprietary medicinal product, it shall forward its reasoned objection, within the said period of 120 days, on the basis of Article 5 of Directive 65/65/EEC.

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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.