Decision of the EEA Joint Committee No 140/2002 of 8 November 2002 amending Annex II (Technical regulations, standards, testing and certification) and Protocol 37 to the EEA Agreement
Date: 2002-11-08
Institutions: EEA Joint Committee
Subjects: drugs classification, market approval, medicinal product, pharmaceutical legislation

23.1.2003

EN

Official Journal of the European Communities

L 19/5

DECISION OF THE EEA JOINT COMMITTEE

No 140/2002

of 8 November 2002

amending Annex II (Technical regulations, standards, testing and certification) and Protocol 37 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 (cid:145)the Agreement(cid:146), and in
particular Articles 98 to 101 thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

Annex II to the Agreement was amended by Decision No 125/2002 of the EEA Joint Committee of
27 September 2002 (1).

Protocol 37 to the Agreement was amended by Decision No 83/1999 of the EEA Joint Committee
of 25 June 1999 (2).

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 No
68/2001 of the EEA Joint Committee (4).

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

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.

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:

(cid:145)14. Committee for Orphan Medicinal Products (Regulation (EC) No 141/2000 of

the European

Parliament and of the Council).(cid:146)

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:

(1) OJ L 336, 12.12.2002, p. 23.
(2) OJ L 296, 23.11.2000, p. 41.
(3) OJ L 18, 22.1.2000, p. 1.
(4) OJ L 238, 6.9.2001, p. 14.

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Official Journal of the European Communities

23.1.2003

(cid:145)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
to the EFTA States’
participation.

this committee shall be amended in order to give full effect

The EFTA States shall contribute financially to the work of the Committee in accordance with Article
82(1)(a) of the Agreement.(cid:146)

Article 3

This Decision shall enter into force on 9 November 2002, provided that all the notifications under Article
103(1) of the Agreement have been made to the EEA Joint Committee (*).

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

Article 4

Done at Brussels, 8 November 2002.

For the EEA Joint Committee

The President

Kjartan J(cid:211)HANNSSON

(*) Constitutional requirements indicated.