Date: 2023-06-29Category: Not ApplicableState: Union GovernmentCountry: Europe
Decision of the EEA Joint Committee No 305/2022 of 9 December 2022 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2023/1247]
**Policy Summary:**
EEA Joint Committee Decision No. 305/2022, dated December 9, 2022, amends Annex II (Technical regulations, standards, testing and certification) to the Agreement on the European Economic Area (EEA). The amendment incorporates Commission Implementing Regulation (EU) 2021/1281 of August 2, 2021, which lays down rules for the application of Regulation (EU) 2019/6 regarding good pharmacovigilance practice and the format, content, and summary of the pharmacovigilance system master file for veterinary medicinal products, into the EEA Agreement. Specifically, the decision inserts point "22j. 32021 R 1281" after point "22i Regulation EU 2022839" of Chapter XIII of Annex II. The Icelandic and Norwegian language texts of Implementing Regulation (EU) 2021/1281 will be published in the EEA Supplement to the Official Journal of the European Union and will be authentic. The decision entered into force on December 10, 2022, following notifications under Article 103(1) of the EEA Agreement. The decision was published in the EEA Section of, and the EEA Supplement to, the Official Journal of the European Union.
Key Entities Referenced
Council of the European Union: A legislative body of the European Union. Mentioned in context with Regulation EU 2019/6
EEA Joint Committee: The decision-making body responsible for amending the EEA Agreement.
EEA Agreement: Agreement on the European Economic Area
Annex II Technical regulations, standards, testing and certification to the EEA Agreement: Section of the EEA Agreement being amended by the decision.
Commission Implementing Regulation EU 2021/1281: A regulation laying down rules for the application of Regulation EU 2019/6 regarding good pharmacovigilance practice for veterinary medicinal products.
Regulation EU 2019/6: Regulation of the European Parliament and of the Council referenced by Commission Implementing Regulation EU 2021/1281.
European Parliament: One of the legislative bodies of the European Union.
Brussels: The city where the decision was made.
29.6.2023 EN Official Journal of the European Union L 164/29
DECISION OF THE EEA JOINT COMMITTEE No 305/2022
of 9 December 2022
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
[2023/1247]
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) 2021/1281 of 2 August 2021laying down rules for the application of
Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice
and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal
products(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 22i (Regulation (EU) 2022/839 of the European Parliament and of the Council)
of Chapter XIII of Annex II to the EEA Agreement:
‘22j. 32021 R 1281: Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021laying down rules for the
application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacov
igilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary
medicinal products (OJ L 279, 3.8.2021, p. 15).’
Article 2
The text of Implementing Regulation (EU) 2021/1281 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 10 December 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, 9 December 2022.
For the EEA Joint Committee
The President
Kristján Andri STEFÁNSSON
(1) OJ L 279, 3.8.2021, p. 15.
* No constitutional requirements indicated.