Date: 2022-09-22Category: Not ApplicableState: Union GovernmentCountry: Europe
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]
This document is a Decision of the EEA Joint Committee No. 119/2022, dated April 29, 2022, amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement. The decision incorporates two Commission Implementing Regulations into the EEA Agreement: (1) Commission Implementing Regulation (EU) 2021/1248 of July 29, 2021, regarding measures on good distribution practice for veterinary medicinal products, and (2) Commission Implementing Regulation (EU) 2021/1280 of August 2, 2021, regarding measures on good distribution practice for active substances used as starting materials in veterinary medicinal products. Article 1 of the decision formally inserts these regulations into Chapter XIII of Annex II of the EEA Agreement, specifically as points 22e and 22f. Article 2 stipulates that the Icelandic and Norwegian language texts of the aforementioned regulations will be published in the EEA Supplement to the Official Journal of the European Union and will be considered authentic. The decision entered into force on April 30, 2022, contingent upon completion of notifications under Article 103(1) of the EEA Agreement, or the entry into force of Decision of the EEA Joint Committee No 371/2021, whichever occurred later. The Decision was signed in Brussels by the President of the EEA Joint Committee, Nicolas VON LINGEN. The decision will be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.
Key Entities Referenced
EEA Joint Committee: The decision-making body responsible for amending the EEA Agreement.
EEA Agreement: Agreement on the European Economic Area
Annex II to the EEA Agreement: Annex II to the EEA Agreement covers technical regulations, standards, testing, and certification.
Commission Implementing Regulation EU 2021/1248: 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.
Commission Implementing Regulation EU 2021/1280: 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.
Regulation EU 2019/6: Regulation EU 2019/6 of the European Parliament and of the Council (referred to in both Commission Implementing Regulations).
Brussels: The city where the EEA Joint Committee decision was finalized.
Nicolas VON LINGEN: The President of the EEA Joint Committee.
L 246/60 EN Official Journal of the European Union 22.9.2022
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 2021as 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 2021as 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 2021as 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.
(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.22.9.2022 EN Official Journal of the European Union L 246/61
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