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Date: 13-Jun-2024 Category: Not Applicable State: Union Government Country: Europe

Decision of the EEA Joint Committee No 313/2023 of 8 December 2023 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/1380]

Issued by EEA Joint Committee · Not Applicable

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Executive Summary & Key Takeaways

What it means

  • The EEA Joint Committee Decision No 313/2023 incorporates Commission Delegated Regulation (EU) 2023/1766 into the EEA Agreement. This regulation adjusts the fees payable to the European Medicines Agency for pharmacovigilance activities related to medicinal products for human use, based on the inflation rate.

Key Changes

  • Annex II to the EEA Agreement is amended to include Commission Delegated Regulation (EU) 2023/1766.
  • The specific addition to Chapter XIII of Annex II is the inclusion of '32023 R 1766: Commission Delegated Regulation (EU) 2023/1766 of 29 June 2023(OJ L 226, 14.9.2023, p. 102).'
  • The decision entered into force on 9 December 2023, contingent upon all notifications under Article 103(1) of the EEA Agreement being made.

Impact Analysis

Pharmaceutical Companies

  • Action Items: Companies should review their budgets and financial forecasts to account for the inflation-adjusted fees. They should also ensure compliance with the updated fee structure when submitting payments to the EMA for pharmacovigilance activities.

European Medicines Agency (EMA)

  • Action Items: The EMA should update its billing systems and communicate the new fee structure to pharmaceutical companies. It should also monitor the impact of the adjusted fees on its revenue and adjust its budget accordingly.

EEA Member States

  • Action Items: EEA member states should review their national laws and regulations to ensure consistency with the updated EEA Agreement. They should also inform relevant stakeholders about the changes.

Key Entities Referenced

EEA Joint Committee: The body responsible for amending the EEA Agreement. European Medicines Agency (EMA): The European agency responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. Commission Delegated Regulation (EU) 2023/1766: The regulation amending Regulation (EU) No 658/2014, adjusting the fees payable to the EMA for pharmacovigilance activities based on inflation. Regulation (EU) No 658/2014: The original regulation concerning fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities. EEA Agreement: The Agreement on the European Economic Area.
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Official Journal EN of the European Union L series 2024/1380 13.6.2024 DECISION OF THE EEA JOINT COMMITTEE No 313/2023 of 8 December 2023 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/1380] 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) 2023/1766 of 29 June 2023amending Regulation (EU) No 658/2014 of the European Parliament and of the Council as regards the adjustment to the inflation rate of the amounts of the fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use(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 16 (Regulation (EU) No 658/2014 of the European Parliament and of the Council) of Chapter XIII of Annex II to the EEA Agreement: ‘— 32023 R 1766: Commission Delegated Regulation (EU) 2023/1766 of 29 June 2023(OJ L 226, 14.9.2023, p. 102).’ Article 2 The text of Delegated Regulation (EU) 2023/1766 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic. (1) OJ L 226, 14.9.2023, p. 102. ELI: http://data.europa.eu/eli/dec/2024/1380/oj 1/2EN OJ L, 13.6.2024 Article 3 This Decision shall enter into force on 9 December 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, 8 December 2023. For the EEA Joint Committee The President Pascal SCHAFHAUSER (*) No constitutional requirements indicated. 2/2 ELI: http://data.europa.eu/eli/dec/2024/1380/oj

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