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 (c. 83)

TITLE XII U.K. STANDING COMMITTEE

Article 120 U.K.

Any changes which are necessary in order to adapt Annex I to take account of scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 121(2).

[F1 Article 121 U.K.

1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use, hereinafter called ‘ the Standing Committee ’ , in the task of adapting to technical progress the directives on the removal of technical barriers to trade in the medicinal products sector.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC 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, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month.

4. The Standing Committee shall adopt its own rules of procedure which shall be made public.]

Textual Amendments

F1 Substituted by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.