DECISION OF THE EEA JOINT COMMITTEE No 63/2022

of 18 March 2022

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2022/1131]

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) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials  ( 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 point is inserted after point 18b (Commission Decision (EU) 2021/1240) of Chapter XIII of Annex II to the EEA Agreement:

‘18c.

32022 R 0020 : Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials ( OJ L 5, 10.1.2022, p. 14 ).’

Article 2

The text of Implementing Regulation (EU) 2022/20 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 19 March 2022, 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, 18 March 2022.

For the EEA Joint Committee

The President

Nicolas VON LINGEN

( 1 )    OJ L 5, 10.1.2022, p. 14 .

( * )   No constitutional requirements indicated.