anx_ANNEX__cpt_1__cpt_4__point_4__text_2

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

‘Article 10a 1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use, referred to in Article 121(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use OJ L 311, 28.11.2001, p. 67. . 2. Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC OJ L 184, 17.7.1999, p. 23.’. shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

← anx_ANNEX__cpt_1__cpt_4__point_4__text_1 · All articles · 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. →

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