DECISION OF THE EEA JOINT COMMITTEE No 114/2020

of 6 August 2020

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2023/1374]

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) Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19)  ( 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 19 (Commission Implementing Regulation (EU) No 699/2014) of Chapter XIII of Annex II to the EEA Agreement:

‘20.

32020 R 1043: Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19) ( OJ L 231, 17.7.2020, p. 12 ).’

Article 2

The text of Regulation (EU) 2020/1043 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 August 2020, 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, 6 August 2020.

For the EEA Joint Committee

The President

Sabine MONAUNI

( 1 )    OJ L 231, 17.7.2020, p. 12 .

( *1 )   No constitutional requirements indicated.