DECISION OF THE EEA JOINT COMMITTEE No 313/2023

of 8 December 2023

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/1380]

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 Delegated Regulation (EU) 2023/1766 of 29 June 2023 amending Regulation (EU) No 658/2014 of the European Parliament and of the Council as regards the adjustment to the inflation rate of the amounts of the fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use ( 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 indent is added in point 16 (Regulation (EU) No 658/2014 of the European Parliament and of the Council) of Chapter XIII of Annex II to the EEA Agreement:

‘—

32023 R 1766 : Commission Delegated Regulation (EU) 2023/1766 of 29 June 2023 ( OJ L 226, 14.9.2023, p. 102 ).’

Article 2

The text of Delegated Regulation (EU) 2023/1766 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 9 December 2023, provided that all the notifications under Article 103(1) of the EEA Agreement have been made ( *1 ) .

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, 8 December 2023.

For the EEA Joint Committee

The President

Pascal SCHAFHAUSER

( 1 ) OJ L 226, 14.9.2023, p. 102 .

( *1 ) No constitutional requirements indicated.

ELI: http://data.europa.eu/eli/dec/2024/1380/oj

ISSN 1977-0677 (electronic edition)