Decision of the EEA Joint Committee No 69/2001 of 19 June 2001 amending Annex II (technical regulations, standards, testing and certification) to the EEA Agreement
Date: 2001-06-19
Institutions: EEA Joint Committee
Subjects: drug surveillance, drugs classification, market approval, medicinal product, pharmaceutical legislation, public health

6.9.2001

EN

Official Journal of the European Communities

L 238/15

DECISION OF THE EEA JOINT COMMITTEE

No 69/2001

of 19 June 2001

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 (cid:145)the Agreement(cid:146), and in
particular Article 98 thereof,

Whereas:

(1)

(2)

(3)

Annex II to the Agreement was amended by Decision No 2/2001 of the Joint Committee of the
EEA of 31 January 2001 (1).

Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of
Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or
administrative action relating to medicinal products (2) is to be incorporated into the Agreement.

Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for
implementation of the criteria for designation of a medical product as an orphan medicinal product
and definitions of the concepts (cid:145)similar medicinal product(cid:146) and (cid:145)clinical superiority(cid:146) (3) is to be
incorporated into the Agreement,

HAS DECIDED AS FOLLOWS:

Article 1

The following indent shall be added in point 3 (Second Council Directive 75/319/EEC) in Chapter XIII of
Annex II to the Agreement:

(cid:145)(cid:151) 32000 L 0038: Commission Directive 2000/38/EC of 5 June 2000 (OJ L 139, 10.6.2000, p.

28).(cid:146)

Article 2

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

(cid:145)15n. 32000 R 0847: Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the
provisions for implementation of the criteria for designation of a medical product as an orphan
medicinal product and definitions of the concepts (cid:147)similar medicinal product(cid:148) and (cid:147)clinical
superiority(cid:148) (OJ L 103, 28.4.2000, p. 5).(cid:146)

Article 3

The texts of Directive 2000/38/EC and Regulation (EC) No 847/2000 in the Icelandic and Norwegian
languages, to be published in the EEA Supplement to the Official Journal of the European Communities shall
be authentic.

(1) OJ L 66, 8.3.2001, p. 44.
(2) OJ L 139, 10.6.2000, p. 28.
(3) OJ L 103, 28.4.2000, p. 5.

L 238/16

EN

Official Journal of the European Communities

6.9.2001

This Decision shall enter into force on 20 June 2001, provided that all the notifications under Article
103(1) of the Agreement have been made to the EEA Joint Committee (*).

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.

Article 5

Done at Brussels, 19 June 2001.

For the EEA Joint Committee

The President

P. WESTERLUND

(*) No constitutional requirements indicated