Article 26

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 competent authority of the Member State concerned shall ensure by means of inspections that the legal requirements relating to proprietary medicinal products are complied with. Such inspections shall be carried out by officials representing the competent authority who must be empowered to: (a) inspect manufacturing or commercial establishments and any laboratories entrusted by the holder of the authorization referred to in Article 16 with the task of carrying out checks pursuant to Article 5 (b); take samples; examine any documents relating to the object of the inspection, subject to the provisions in force in the Member States at the time of notification of this Directive and which place restrictions on these powers with regard to the descriptions of the method of preparation.

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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.