Article 12

Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products · European Union

All decisions taken pursuant to Articles 5, 6 or 11 shall state in detail the reasons on which they are based. A decision shall be notified to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force and of the time limit allowed for the exercise of such remedies. Authorisations to place a proprietary product on the market and decisions to revoke authorisations shall be published by each Member State in the appropriate official publication. CHAPTER IV Labelling of proprietary medicinal products

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.