art_7__para

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

Notwithstanding the provisions of Chapter IV and of Article 21 of Directive 65/65/EEC, Member States may require that the proprietary medicinal product shall be labelled so as to indicate on the container and/or outer packaging and/or on the package leaflet other requirements essential to safety or for the protection of public health, including any particular precautions to be taken in using the product and any other warnings based on the results of the clinical trials and pharmacological tests mentioned in point 8 of Article 4, second paragraph, of Directive 65/65/EEC, or resulting from experience in the course of use of the proprietary medicinal product after marketing. CHAPTER III Committee for Proprietary Medicinal Products

National law under this provision

2 national measures recorded under this provision, in 1 form — sign in to view the analysis.

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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.