art_9__para_8

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use · European Union

8. In consultation with Member States, the Commission shall draw up and publish detailed guidance on: the format and contents of the request referred to in paragraph 2 as well as the documentation to be submitted to support that request, on the quality and manufacture of the investigational medicinal product, any toxicological and pharmacological tests, the protocol and clinical information on the investigational medicinal product including the investigator's brochure; the presentation and content of the proposed amendment referred to in point (a) of Article 10 on substantial amendments made to the protocol; the declaration of the end of the clinical trial.

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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.