DECISION OF THE EEA JOINT COMMITTEE No 127/2026

of 30 April 2026

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2026/1504]

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 Implementing Regulation (EU) 2025/163 of 30 January 2025 amending Implementing Regulation (EU) 2021/17 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council ( 1 ) is to be incorporated into the EEA Agreement.

(2) Commission Implementing Regulation (EU) 2025/1466 of 22 July 2025 amending Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council ( 2 ) is to be incorporated into the EEA Agreement.

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

HAS ADOPTED THIS DECISION:

Article 1

Chapter XIII of Annex II to the EEA Agreement is amended as follows:

The following is added in point 15zq (Commission Implementing Regulation (EU) No 520/2012):

‘, as amended by:

— 32025 R 1466 : Commission Implementing Regulation (EU) 2025/1466 of 22 July 2025 ( OJ L, 2025/1466, 23.7.2025 ).’

The following indent is added in point 22b (Commission Implementing Regulation (EU) 2021/17):

‘—

32025 R 0163 : Commission Implementing Regulation (EU) 2025/163 of 30 January 2025 ( OJ L, 2025/163, 31.1.2025 ).’

Article 2

The texts of Implementing Regulations (EU) 2025/163 and (EU) 2025/1466 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 1 May 2026, 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, 30 April 2026.

For the EEA Joint Committee

The President

Nicolas VON LINGEN

( 1 ) OJ L, 2025/163, 31.1.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/163/oj .

( 2 ) OJ L, 2025/1466, 23.7.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/1466/oj .

( *1 ) [No constitutional requirements indicated.] [Constitutional requirements indicated.]

ELI: http://data.europa.eu/eli/dec/2026/1504/oj

ISSN 1977-0677 (electronic edition)