Division 2.5 Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (codified version)

As regards Directive 2004/9/EC, the Commission should be empowered to adapt Annex I to technical progress and change the formula in Article 2(2). Since those measures are of general scope and are designed to amend non-essential elements of Directive 2004/9/EC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

Accordingly, Directive 2004/9/EC is hereby amended as follows:

1. 1..

   Article 6(3) shall be replaced by the following:

   ‘3.

   If the Commission considers that amendments to this Directive are necessary in order to resolve the matters referred to in paragraph 1, it shall adopt those amendments.

   Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;

2. 2..

   Article 7 shall be replaced by the following:

   ‘Article 7

   1.

   The Commission shall be assisted by the Committee established by Article 29(1) of Council Directive 67/548/EEC^f2, hereinafter “the Committee”.

   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, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

3. 3..

   Article 8(2) shall be replaced by the following:

   ‘2.

   The Commission shall adopt implementing measures for the following:

   (a)

   the adaptation of the formula referred to in Article 2(2);

   (b)

   the adaptation of Annex I to take account of technical progress.

   Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’