# L_2023164EN.01002901.xml

| 29.6.2023 | EN | Official Journal of the European Union | L 164/29 |
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29.6.2023

EN

Official Journal of the European Union

L 164/29

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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 2021 laying 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. |
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(1)

Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 laying 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, |
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(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 2021 laying 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 (OJ L 279, 3.8.2021, p. 15).’ |
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‘22j.

32021 R 1281: Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 laying 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 (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 (*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, 9 December 2022.

For the EEA Joint Committee

The President

Kristján Andri STEFÁNSSON

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(1)  
  OJ L 279, 3.8.2021, p. 15.

1

(*1)  No constitutional requirements indicated.

*1

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