lexiara

art_26__para

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);

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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.