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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]
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]
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.
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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:
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(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. |
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(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:
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— |
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.