Decision No 4/2002 of the Association Council, Association between the European Communities and their Member States, of the one part, and the Republic of Hungary, of the other part,

of 9 October 2002

bringing into operation the Annex on good laboratory practice of the Protocol to the Europe Agreement on conformity assessment and acceptance of industrial products

(2003/50/EC)

THE ASSOCIATION COUNCIL,

Having regard to the Europe Agreement establishing an Association between the European Communities and their Member States, of the one part, and the Republic of Hungary, of the other part(1),

Having regard to the Protocol to the Europe Agreement on conformity assessment and acceptance of industrial products(2), and in particular to section IV of the Annex on good laboratory practice for medicinal products for human use thereto,

Whereas:

(1) The entry into operation of the sectoral Annex on mutual recognition of results of conformity assessment in the field of good laboratory practice (GLP) for medicinal products for human use is conditional on a decision of the Association Council in the light of the mutual joint visits to Hungary according to the OECD pilot project on examination of national GLP compliance monitoring programmes.

(2) Such visits have taken place in a satisfactory way and the conditions are therefore in place for the entry into operation of the sectoral Annex,

HAS DECIDED AS FOLLOWS:

Sole Article

The Annex on mutual recognition of results of conformity assessment in the field of good laboratory practice for medicinal products for human use to the Protocol to the Europe Agreement on conformity assessment and acceptance of industrial products shall enter into operation on the first day of the second month following the adoption of this Decision.

Done at Brussels, 9 October 2002.

For the Association Council

The President

P. S. Møller

(1) OJ L 347, 31.12.1993, p. 2.

(2) OJ L 135, 17.5.2001, p. 37.