Council Decision (EU) 2024/1844 of 25 June 2024 on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning the amendment of Annex II (Technical regulations, standards, testing and certification) and Protocol 37 containing the list provided for in Article 101 to the EEA Agreement (Reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices)Text with EEA relevance.

• CELEX: Decision (EU) 2024/1844
• Articles: 8

Article 1

The position to be adopted, on behalf of the Union, within the EEA Joint Committee on the proposed amendment of Annex II (Technical Regulations, standards, testing and certification) and Protocol 37 containing the list provided for in Article 101 to the EEA Agreement, shall be based on the draft Decision of the EEA Joint Committee attached to this Decision.

Article 1

Chapter XIII of Annex II to the EEA Agreement shall be amended as follows:

1.

The following two paragraphs are inserted after the eighteenth paragraph of the introductory part:

‘The EFTA States shall be fully associated with the work of the Executive Steering Group on Shortages and Safety of Medicinal Products as set up by Article 3 of Regulation (EU) 2022/123 of the European Parliament and of the Council and shall have the same rights and obligations within it as the EU Member States, except for the right to vote.

The EFTA States shall be fully associated with the work of the Emergency Task Force as set up by Article 15 of Regulation (EU) 2022/123 of the European Parliament and of the Council and shall have the same rights and obligations within it as the EU Member States, except for the right to vote.’.

2.

The text of point 15ze is replaced by the following:

‘

32022 R 0123 : Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices ( OJ L 20, 31.1.2022, p. 1 ), as corrected by OJ L 71, 9.3.2023, p. 37 .

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:

In Article 34(2), the words “or Article 53 of the EEA Agreement” shall be inserted after the words “Article 101 TFEU”.’.

Article 2

This Decision shall enter into force on the date of its adoption.

Article 2

The following point is inserted after point 15 (Commission Implementing Regulation (EU) 2020/1207) of Chapter XXX of Annex II to the EEA Agreement:

‘16.

32022 R 0123 : Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices ( OJ L 20, 31.1.2022, p. 1 ), as corrected by OJ L 71, 9.3.2023, p. 37 .

Modalities for the association of the EFTA States in accordance with Article 101 of this Agreement:

The EFTA States shall be fully associated with the work of the Executive Steering Group on Shortages of Medical Devices and shall have the same rights and obligations within it as the EU Member States, except for the right to vote.

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:

In Article 34(2), the words “or Article 53 of the EEA Agreement” shall be inserted after the words “Article 101 TFEU”.’.

Article 3

The text of point 30 of Protocol 37 to the EEA Agreement is replaced by the following:

‘Executive Steering Group on Shortages and Safety of Medicinal Products, Emergency Task Force and Executive Steering Group on Shortages of Medical Devices (Regulation (EU) 2022/123 of the European Parliament and of the Council).’.

Article 4

The text of Regulation (EU) 2022/123, as corrected by OJ L 71, 9.3.2023, p. 37 , 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 5

This Decision shall enter into force on …, provided that all the notifications under Article 103(1) of the EEA Agreement have been made  ( *1 ) .

Article 6

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union .