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Date: 18-Jan-2024 Category: Not Applicable State: Union Government Country: Europe

Decision of the EEA Joint Committee No 107/2021 of 19 March 2021 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/91]

Issued by EEA Joint Committee · Not Applicable

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Executive Summary & Key Takeaways

What it means

  • The EEA Joint Committee Decision No 107/2021 incorporates Commission Delegated Regulation (EU) 2020/1431 into the EEA Agreement, specifically amending Annex II concerning technical regulations, standards, testing, and certification.
  • Commission Delegated Regulation (EU) 2020/1431 adjusts the fees payable to the European Medicines Agency (EMA) for pharmacovigilance activities related to medicinal products for human use, accounting for inflation.

Key Changes

  • Annex II to the EEA Agreement is amended to include reference to Commission Delegated Regulation (EU) 2020/1431.
  • The specific addition to Chapter XIII of Annex II is: ‘- 32020 R 1431: Commission Delegated Regulation (EU) 2020/1431 of 14 July 2020(OJ L 331, 12.10.2020, p. 2).’
  • The Decision entered into force on 20 March 2021, contingent upon completion of notifications under Article 103(1) of the EEA Agreement.
  • The adjusted fees relate to pharmacovigilance activities conducted by the European Medicines Agency (EMA).

Impact Analysis

Impact on Pharmaceutical Companies

  • Companies should ensure compliance with the updated fee structure when making payments to the EMA.

Impact on European Medicines Agency (EMA)

  • The EMA needs to update its billing and accounting systems to reflect the new fee structure.

Impact on EEA Member States

  • No immediate direct financial impact on EEA member states is anticipated, as the adjustment concerns fees paid by pharmaceutical companies to the EMA.

Suggested Action Items

  • EEA member states should ensure that the amended Annex II is properly implemented into national law and regulations.

Key Entities Referenced

EEA Joint Committee: The body responsible for amending the EEA Agreement. European Medicines Agency (EMA): The agency responsible for the scientific evaluation, supervision and safety monitoring of medicines in the European Union. Commission Delegated Regulation (EU) 2020/1431: Regulation amending Regulation (EU) No 658/2014 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. EEA Agreement: The Agreement on the European Economic Area. Regulation (EU) No 658/2014: Regulation of the European Parliament and of the Council, which is being amended by Commission Delegated Regulation (EU) 2020/1431.
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Official Journal EN of the European Union L series 2024/91 18.1.2024 DECISION OF THE EEA JOINT COMMITTEE No 107/2021 of 19 March 2021 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/91] 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) 2020/1431 of 14 July 2020amending 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: ‘- 32020 R 1431: Commission Delegated Regulation (EU) 2020/1431 of 14 July 2020(OJ L 331, 12.10.2020, p. 2).’ Article 2 The text of Delegated Regulation (EU) 2020/1431 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 20 March 2021, 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, 19 March 2021. For the EEA Joint Committee The President Clara GANSLANDT (1) OJ L 331, 12.10.2020, p. 2. * No constitutional requirements indicated. ELI: http://data.europa.eu/eli/dec/2024/91/oj 1/1

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