Article 13

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

The Committee may set a time limit for a fresh examination on the basis of particulars relating to the conditions laid down in Articles 5, 11 or 20 of Directive 65/65/EEC obtained in the meantime by the Member States, in particular by those which have authorized the proprietary medicinal product.

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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.