DECISION OF THE EEA JOINT COMMITTEE No 18/2025

of 7 February 2025

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2025/727]

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) 2024/1701 of 11 March 2024 amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for 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 15zi (Commission Regulation (EC) No 1234/2008) of Chapter XIII of Annex II to the EEA Agreement:

‘—

32024 R 1701 : Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024 ( OJ L, 2024/1701, 17.6.2024 ).’

Article 2

The text of Delegated Regulation (EU) 2024/1701 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 8 February 2025, 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, 7 February 2025.

For the EEA Joint Committee

The President

Nicolas VON LINGEN

( 1 ) OJ L, 2024/1701, 17.6.2024, ELI: http://data.europa.eu/eli/reg_del/2024/1701/oj .

( *1 ) No constitutional requirements indicated.

ELI: http://data.europa.eu/eli/dec/2025/727/oj

ISSN 1977-0677 (electronic edition)