art_13__para_3

3. Member States shall take all appropriate measures to ensure that the qualified person referred to in Article 21 of Directive 75/319/EEC, without prejudice to his relationship with the manufacturer or importer, is responsible, in the context of the procedures referred to in Article 25 of the said Directive, for ensuring: in the case of investigational medicinal products manufactured in the Member State concerned, that each batch of medicinal products has been manufactured and checked in compliance with the requirements of Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use (12), the product specification file and the information notified pursuant to Article 9(2) of this Directive; in the case of investigational medicinal products manufactured in a third country, that each production batch has been manufactured and checked in accordance with standards of good manufacturing practice at least equivalent to those laid down in Commission Directive 91/356/EEC, in accordance with the product specification file, and that each production batch has been checked in accordance with the information notified pursuant to Article 9(2) of this Directive; in the case of an investigational medicinal product which is a comparator product from a third country, and which has a marketing authorisation, where the documentation certifying that each production batch has been manufactured in conditions at least equivalent to the standards of good manufacturing practice referred to above cannot be obtained, that each production batch has undergone all relevant analyses, tests or checks necessary to confirm its quality in accordance with the information notified pursuant to Article 9(2) of this Directive. Detailed guidance on the elements to be taken into account when evaluating products with the object of releasing batches within the Community shall be drawn up pursuant to the good manufacturing practice guidelines, and in particular Annex 13 to the said guidelines. Such guidelines will be adopted in accordance with the procedure referred to in Article 21(2) of this Directive and published in accordance with Article 19a of Directive 75/319/EEC. Insofar as the provisions laid down in (a), (b) or (c) are complied with, investigational medicinal products shall not have to undergo any further checks if they are imported into another Member State together with batch release certification signed by the qualified person.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-03 · Text as adopted (Official Journal); later amendments are not incorporated in this text.