COUNCIL DECISION

of 19 July 1999

concerning the conclusion of the Agreement on mutual recognition of OECD principles of good laboratory practice (GLP) and compliance monitoring programmes between the European Community and the State of Israel

(1999/662/EC)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 133 thereof, in conjunction with the first sentence of Article 300(2) and the first subparagraph of Article 300(3) and Article 300(4),

Having regard to the proposal from the Commission,

Whereas:

(1) the Agreement on mutual Recognition of OECD principles of good laboratory practice (GLP) and compliance monitoring programmes, initialled in Brussels on 16 January 1997, was negotiated by the Commission in accordance with its negotiating guidelines and should be approved;

(2) certain aspects of implementation have been assigned to the Joint Committee established by the Agreement, and in particular the power to amend certain parts of the two Annexes;

(3) it is necessary to lay down the internal procedures required for the proper functioning of the Agreement; the Commission should be empowered to make certain technical changes to the Agreement and to take certain decisions concerning its implementation,

HAS DECIDED AS FOLLOWS:

Article 1

The Agreement on mutual recognition of OECD principles of good laboratory practice (GLP) and compliance monitoring programmes between the European Community and the State of Israel is hereby approved on behalf of the Community.

The text of the Agreement and the Agreed Minutes are attached to this Decision.

Article 2

The President of the Council shall, on behalf of the Community, transmit the note provided for in Article 16 of the Agreement(1).

Article 3

1. The Commission, assisted by the Special Committee appointed by the Council, shall represent the Community in the Joint Committee provided for in Article 10 of the Agreement. After consulting the Special Committee, the Commission shall carry out the notifications, consultations and exchanges of information, shall make the requests for inspections and for participation in inspections, and, if need be, shall reply to requests, in accordance with Articles 3(2), 5(2), 6, 7, 9 and 12 of the Agreement and in Annex II thereto, and adopt the Decision provided for in Article 11(2) and (3) and the second sentence of Article 12.

2. The position of the Community within the Joint Committee, with regard to amendments to Annex I decided on in accordance with the second sentence of Article 4 of the Agreement and to amendments to Annex II decided on in accordance with Article 5 of the Agreement, shall be adopted by the Commission after it has consulted the Special Committee referred to in paragraph 1 of this Article.

3. All other decisions shall be taken by the Council, acting by a qualified majority on a proposal from the Commission.

Done at Brussels, 19 July 1999.

For the Council

The President

T. HALONEN

(1) The date of entry into force of the Agreement will be published in the Official Journal of the European Communities by the General Secretariat of the Council.