Decision of the EEA Joint Committee

No 33/2002

of 19 April 2002

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area, as amended by the Protocol adjusting the Agreement on the European Economic Area, hereinafter referred to as "the Agreement", and in particular Article 98 thereof,

Whereas:

(1) Annex II to the Agreement was amended by Decision of the EEA Joint Committee No 13/2002 of 1 March 2002(1).

(2) 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(2) is to be incorporated into the Agreement,

HAS DECIDED AS FOLLOWS:

Article 1

The following point shall be inserted after point 15n (Commission Regulation (EC) No 847/2000) in Chapter XIII of Annex II to the Agreement:

"15o. 32001 L 0020: 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)."

Article 2

The text of Directive 2001/20/EC in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Communities, shall be authentic.

Article 3

This Decision shall enter into force on 20 April 2002, provided that all the notifications under Article 103(1) of the Agreement have been made to the EEA Joint Committee(3).

Article 4

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Communities.

Done at Brussels, 19 April 2002.

For the EEA Joint Committee

The President

P. Westerlund

(1) OJ L 110, 25.4.2002, p. 5.

(2) OJ L 121, 1.5.2001, p. 34.

(3) No constitutional requirements indicated.