Decision of the EEA Joint Committee No 75/2000 of 2 October 2000 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
Date: 2000-10-02
Institutions: EEA Joint Committee
Subjects: European Medicines Agency, approximation of laws, market approval, medicinal product, pharmaceutical legislation, pharmaceutical product

L 315/12

EN

Official Journal of the European Communities

14.12.2000

DECISION OF THE EEA JOINT COMMITTEE

No 75/2000

of 2 October 2000

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 adjusted 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)

(4)

(5)

(6)

Annex II to the Agreement was amended by Decision No 57/2000 of the EEA Joint Committee of
28 June 2000 (1).

Commission Regulation (EC) No 1069/98 of 26 May 1998 amending Regulation (EC) No 542/95
of 10 March 1995 concerning the examination of variations to the terms of a marketing
authorisation falling within the scope of Council Regulation (EEC) No 2309/93 (2)
is to be
incorporated into the Agreement.

Commission Regulation (EC) No 1146/98 of 2 June 1998 amending Regulation (EC) No 541/95
concerning the examination of variations in the terms of a marketing authorisation granted by a
competent authority of a Member State (3) is to be incorporated into the Agreement.

Council Regulation (EC) No 2743/98 of 14 December 1998 amending Regulation (EC) No 297/95
on fees payable to the European Agency for the Evaluation of Medicinal Products (4)
is to be
incorporated into the Agreement.

Commission Directive 1999/82/EC of 8 September 1999 amending the Annex to Council Directive
75/318/EEC on the approximation of
the Member States relating to analytical,
pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal
products (5) is to be incorporated into the Agreement.

the laws of

Commission Directive 1999/83/EC of 8 September 1999 amending the Annex to Council Directive
75/318/EEC on the approximation of
the Member States relating to analytical,
pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal
products (6) is to be incorporated into the Agreement,

the laws of

HAS DECIDED AS FOLLOWS:

Article 1

The following indents shall be added in point 2 (Council Directive 75/318/EEC) in Chapter XIII of Annex
II to the Agreement:

(cid:145)(cid:151) 399 L 0082: Commission Directive 1999/82/EC of 8 September 1999 (OJ L 243, 15.9.1999,

p. 7),

(cid:151) 399 L 0083: Commission Directive 1999/83/EC of 8 September 1999 (OJ L 243, 15.9.1999,

p. 9).(cid:146)

(1) OJ L 237, 21.9.2000, p. 73.
(2) OJ L 153, 27.5.1998, p. 11.
(3) OJ L 159, 3.6.1998, p. 31.
(4) OJ L 345, 19.12.1998, p. 3.
(5) OJ L 243, 15.9.1999, p. 7.
(6) OJ L 243, 15.9.1999, p. 9.

14.12.2000

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Official Journal of the European Communities

L 315/13

Article 2

The following shall be added in point 15h (Council Regulation (EC) No 297/95) in Chapter XIII of Annex
II to the Agreement:

(cid:145), as amended by:

(cid:151) 398 R 2743: Council Regulation (EC) No 2743/98 of 14 December 1998 (OJ L 345, 19.12.1998,

p. 3).(cid:146)

Article 3

The following shall be added in point 15j (Commission Regulation (EC) No 541/95) in Chapter XIII of
Annex II to the Agreement:

(cid:145), as amended by:

(cid:151) 398 R 1146: Commission Regulation (EC) No 1146/98 of 2 June 1998 (OJ L 159, 3.6.1998,

p. 31).(cid:146)

Article 4

The following shall be added in point 15k (Commission Regulation (EC) No 542/95) in Chapter XIII of
Annex II to the Agreement:

(cid:145), as amended by:

(cid:151) 398 R 1069: Commission Regulation (EC) No 1069/98 of 26 May 1998 (OJ L 153, 27.5.1998,

p. 11).(cid:146)

Article 5

The texts of Regulations (EC) No 1069/98 and (EC) No 1146/98, Regulation (EC) No 2743/98 and
Directives 1999/82/EC and 1999/83/EC in the Icelandic and Norwegian languages, to be published in the
EEA Supplement to the Official Journal of the European Communities, shall be authentic.

Article 6

This Decision shall enter into force on 3 October 2000, 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 7

Done at Brussels, 2 October 2000.

For the EEA Joint Committee

The President

G. S. GUNNARSSON

(*) No constitutional requirements indicated.