Draft DECISION OF THE EEA JOINT COMMITTEE amending Protocol 37 and Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement - Draft common position of the Community

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. Article 101 of the EEA Agreement provides for EEA EFTA association in the work of certain committees when it is called for by the good functioning of that EEA Agreement.

2. The Committee for Orphan Medicinal Products (Regulation (EC) No 141/2000 of the European Parliament and of the Council) does not fall clearly under any of the categories defined in Articles 81, 99 and 100. However, the work of the Committee is closely related to the work of the European Agency for the Evaluation of Medicinal Products and to that of the Committee for Proprietary Medicinal Products (Second Council Directive 75/319/EEC) and it would be appropriate to provide for a similar participation in it.

The EEA EFTA States' participation in the two above mentioned bodies is based on the EEA Joint Committee Decision No 74/1999 of 28 May 1999 (OJ L 284, 9.11.2000, p. 65). The modalities proposed for the EFTA participation in the Committee for Orphan Medicinal Products are the same as the corresponding modalities laid down in that Decision.

3. The EEA Joint Committee should therefore adopt the attached decision to amend Protocol 37 and Annex II to the EEA Agreement by including Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products into Protocol 37 containing the list provided for in Article 101.

4. The proposal includes adaptations to the act extended to the EEA which introduce changes that are more than mere technical adjustments.

5. Article 1(3)(a) of Council Regulation (EC) No 2894/94 concerning the arrangements for implementing the EEA Agreement envisages that the Council establish the Community position for decisions extending Community legislation with substantial changes.

6. The Council is requested to approve the attached draft decision for adoption by the EEA Joint Committee. The Commission would hope to be able to put forward the position of the Community in the EEA Joint Committee in November 2002.

Draft DECISION OF THE EEA JOINT COMMITTEE amending Protocol 37 and 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 Articles 98 to 101 thereof,

Whereas:

(1) Annex II to the Agreement was amended by Decision of the EEA Joint Committee No ... of... [1].

[1] OJ L ...

(2) Protocol 37 to the Agreement was amended by Decision of the EEA Joint Committee No ... of ... [2].

[2] OJ L ...

(3) Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products [3] was incorporated into the Agreement by Decision of the EEA Joint Committee No 68/2001 [4].

[3] OJ L 18, 22.1.2000, p. 1.

[4] OJ L 238, 6.9.2001, p.14

(4) The EFTA States concerned shall be associated with the work of the Committee for Orphan Medicinal Products.

(5) It is necessary to amend Protocol 37 to the Agreement, which lists committees to the work of which experts from EFTA States shall be associated when it is called for by the good functioning of the Agreement.

(6) It is necessary to amend Annex II to the Agreement in connection with the amendment of Protocol 37 in order to specify the detailed arrangements of association,

HAS DECIDED AS FOLLOWS:

Article 1

The following point shall be inserted in Protocol 37 (containing the list provided for in Article 101) to the Agreement:

'14. Committee for Orphan Medicinal Products (Regulation (EC) No 141/2000 of the European Parliament and of the Council).'

Article 2

The following shall be added in point 15m (Regulation (EC) No 141/2000 of the European Parliament and of the Council) of Chapter XIII of Annex II to the Agreement:

'The provisions of the Regulation shall, for the purposes of the present Agreement, be read with the following adaptation:

The EFTA States shall be fully associated with the work of the Committee for Orphan Medicinal Products. The detailed arrangements of participation for the representatives of EFTA States shall be in accordance with the provisions of Article 4 of the Regulation. Such representatives will, however, not participate in the voting and their positions shall be recorded separately. The position of Chairman shall be reserved for a member nominated by a Member State of the Community. The internal rules of procedure of these committees shall be amended in order to give full effect to the EFTA States' participation.

The EFTA States shall contribute financially to the work of the Committee in accordance with Article 82(1)(a) of the Agreement.'

Article 3

This Decision shall enter into force on..., provided that all the notifications under Article 103(1) of the Agreement have been made to the EEA Joint Committee [5].

[5] [Constitutional requirements indicated.][No constitutional requirements indicated.]

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, .

For the EEA Joint Committee

The President

The Secretaries to the EEA Joint Committee