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Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Four · European Union

As regards Directive 2001/20/EC, the Commission should be empowered in particular to adopt principles relating to good clinical practice and detailed rules in line with those principles, to lay down specific requirements and to adapt certain provisions. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2001/20/EC, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

← 1.5. 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 OJ L 121, 1.5.2001, p. 34. · All articles · anx_ANNEX__cpt_1__cpt_5__text_2 →

Source: EUR-Lex (Cellar) · retrieved 2026-10-21 · Text as adopted (Official Journal); later amendments are not incorporated in this text.