Decision of the EEA Joint Committee No 119/2022 of 29 April 2022 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2022/1563]
Date: 2022-04-29
Institutions: EEA Joint Committee
Subjects: European Economic Area, distributive trades, drug surveillance, market approval, product quality, quality standard, revision of an agreement, technical specification, veterinary legislation, veterinary medicinal product




L_2022246EN.01006001.xml










22.9.2022   


EN


Official Journal of the European Union


L 246/60








            DECISION OF THE EEA JOINT COMMITTEE No 119/2022
of 29 April 2022
         
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2022/1563]


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) 2021/1248 of 29 July 2021 as regards measures on good distribution practice for veterinary medicinal products 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) 2021/1280 of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 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
The following points are inserted after point 22d (Commission Implementing Regulation (EU) 2021/1904) of Chapter XIII of Annex II to the EEA Agreement:






‘22e.



32021 R 1248: Commission Implementing Regulation (EU) 2021/1248 of 29 July 2021 as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (OJ L 272, 30.7.2021, p. 46).










22f.



32021 R 1280: Commission Implementing Regulation (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (OJ L 279, 3.8.2021, p. 1).’






Article 2
The texts of Implementing Regulations (EU) 2021/1248 and (EU) 2021/1280 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 30 April 2022, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (*), or on the day of the entry into force of Decision of the EEA Joint Committee No 371/2021 of 10 December 2021 (3), whichever is the later.


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, 29 April 2022.


For the EEA Joint Committee


The President

Nicolas VON LINGEN
            





(1)  
            OJ L 272, 30.7.2021, p. 46.

(2)  
            OJ L 279, 3.8.2021, p. 1.

(*)  No constitutional requirements indicated.

(3)  Not yet published in the Official Journal.