art_11__para_1

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

1. Member States in whose territory the clinical trial takes place shall enter in a European database, accessible only to the competent authorities of the Member States, the Agency and the Commission: extracts from the request for authorisation referred to in Article 9(2); any amendments made to the request, as provided for in Article 9(3); any amendments made to the protocol, as provided for in point a of Article 10; the favourable opinion of the Ethics Committee; the declaration of the end of the clinical trial; and a reference to the inspections carried out on conformity with good clinical practice.

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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.