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Document 22021D1505

Decision of the EEA Joint Committee No 238/2018 of 5 December 2018 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2021/1505]

C/2018/8339

OJ L 337, 23.9.2021, p. 30–30 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

Date of entry into force unknown (pending notification) or not yet in force., Date of effect: 01/01/1001

ELI: http://data.europa.eu/eli/dec/2021/1505/oj

23.9.2021   

EN

Official Journal of the European Union

L 337/30


DECISION OF THE EEA JOINT COMMITTEE No 238/2018

of 5 December 2018

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2021/1505]

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (“the EEA Agreement”), and in particular Article 98 thereof,

Whereas:

(1)

Commission Regulation (EU) 2018/781 of 29 May 2018 amending Regulation (EC) No 847/2000 as regards the definition of the concept ‘similar medicinal product’ (1) is to be incorporated into the EEA Agreement.

(2)

Annex II to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The following is added in point 15n (Commission Regulation (EC) No 847/2000) of Chapter XIII of Annex II to the EEA Agreement:

‘, as amended by:

32018 R 0781: Commission Regulation (EU) 2018/781 of 29 May 2018 (OJ L 132, 30.5.2018, p. 1).’

Article 2

The text of Commission Regulation (EU) 2018/781 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3

This Decision shall enter into force on 6 December 2018, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (*).

Article 4

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

Done at Brussels, 5 December 2018.

For the EEA Joint Committee

The President

Oda Helen SLETNES

The Secretaries

To the EEA Joint Committee

Hege M. HOFF

Mikołaj KARŁOWSKI


(1)  OJ L 132, 30.5.2018, p. 1.

(*)  No constitutional requirements indicated.


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