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Date: 21-Mar-2024 Category: Not Applicable State: Union Government Country: Europe

Decision of the EEA Joint Committee No 179/2023 of 5 July 2023 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/800]

Issued by EEA Joint Committee · Not Applicable

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Executive Summary & Key Takeaways

What it means

  • The Decision of the EEA Joint Committee No 179/2023 incorporates Commission Delegated Regulation (EU) 2023/183 into the EEA Agreement by amending Annex II, specifically Chapter XIII, point 22. This regulation concerns compliance with good laboratory practice for veterinary medicinal products.

Key Changes

  • Adds Commission Delegated Regulation (EU) 2023/183 of 23 November 2022 to point 22 of Chapter XIII of Annex II to the EEA Agreement.
  • Delegated Regulation (EU) 2023/183 amends Regulation (EU) 2019/6 of the European Parliament and of the Council regarding requirements on compliance with good laboratory practice for veterinary medicinal products.
  • The Decision entered into force on 6 July 2023, provided all notifications under Article 103(1) of the EEA Agreement were made.
  • The authentic text of Delegated Regulation (EU) 2023/183 in Icelandic and Norwegian languages will be published in the EEA Supplement to the Official Journal of the European Union.

Impact Analysis

Veterinary Medicinal Product Manufacturers and Laboratories

  • Action Items: Review and update internal procedures and quality control systems to ensure compliance with the new requirements. Conduct necessary training for personnel involved in laboratory practices. Prepare for potential inspections to verify compliance.

EEA Member States

  • Action Items: Review and amend national laws to reflect the requirements of Commission Delegated Regulation (EU) 2023/183. Communicate the changes to relevant stakeholders within the country. Implement monitoring and enforcement mechanisms to ensure compliance.

European Economic Area (EEA)

  • Action Items: Monitor the implementation of the regulation across member states. Address any discrepancies or challenges in implementation. Provide guidance and support to stakeholders as needed.

Key Entities Referenced

EEA Joint Committee: The decision-making body responsible for amending the EEA Agreement. Commission Delegated Regulation (EU) 2023/183: Regulation amending Regulation (EU) 2019/6 regarding requirements on compliance with good laboratory practice for veterinary medicinal products. Regulation (EU) 2019/6: Regulation of the European Parliament and of the Council related to veterinary medicinal products. EEA Agreement: The Agreement on the European Economic Area.
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Official Journal EN of the European Union L series 2024/800 21.3.2024 DECISION OF THE EEA JOINT COMMITTEE No 179/2023 of 5 July 2023 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/800] 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 Delegated Regulation (EU) 2023/183 of 23 November 2022amending Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the requirements on compliance with good laboratory practice for veterinary medicinal products set out in Annex II to that Regulation(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 indent is added in point 22 (Regulation (EU) 2019/6 of the European Parliament and of the Council) of Chapter XIII of Annex II to the EEA Agreement: ‘— 32023 R 0183: Commission Delegated Regulation (EU) 2023/183 of 23 November 2022(OJ L 26, 30.1.2023, p. 7).’ Article 2 The text of Delegated Regulation (EU) 2023/183 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 July 2023, 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, 5 July 2023. For the EEA Joint Committee The President Pascal SCHAFHAUSER (1) OJ L 26, 30.1.2023, p. 7. * Constitutional requirements indicated. ELI: http://data.europa.eu/eli/dec/2024/800/oj 1/1

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