Article 39

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. As regards the authorizations referred to in Article 16 issued before the expiry of the time limit laid down in Article 38, Member States may grant an additional period of one year to the undertakings concerned to enable them to comply with the provisions of Chapter IV. 2. Within 15 years of the notification referred to in Article 38, the other provisions of this Directive shall be applied progressively to proprietary medicinal products placed on the market by virtue of previous provisions. 3. Member States shall notify the Commission, within three years following the notification of this Directive, of the number of proprietary medicinal products covered by paragraph 2, and, each subsequent year, of the number of these products for which a marketing authorization referred to in Article 3 of Directive 65/65/EEC, has not yet been issued.

← art_38__para · All articles · 1. →

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