art_6__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

Where a leaflet is enclosed with the packaging of a proprietary medicinal product Member States shall take all appropriate measures to ensure that it applies to the product in question only. All the information given in the leaflet must be in accordance with the particulars and documents supplied pursuant to Article 4 of Directive 65/65/EEC and must be approved by the competent authorities. The leaflet must include at least the following information: (a) name and domicile or corporate name and domicile or registered place of business of the person responsible for marketing the product and, where applicable, of the manufacturer; Member State may require that a leaflet be included with the packaging.

National law under this provision

2 national measures recorded under this provision, in 2 forms — 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.