Considerations on COM(2024)242 - EU position concerning an amendment to 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)

Please note

This page contains a limited version of this dossier in the EU Monitor.

 
dossier COM(2024)242 - EU position concerning an amendment to Annex II (Technical regulations, standards, testing and certification) and Protocol ...
document COM(2024)242 EN
date June 25, 2024
 
table>(1)The Agreement on the European Economic Area (2) (‘the EEA Agreement’) entered into force on 1 January 1994.
(2)Pursuant to Article 98 of the EEA Agreement, the EEA Joint Committee may decide to amend, inter alia, Annex II (Technical Regulations, standards, testing and certification) (‘Annex II’) and Protocol 37 containing the list provided for in Article 101 (‘Protocol 37’) to the EEA Agreement.

(3)Regulation (EU) 2022/123 of the European Parliament and of the Council (3) should be incorporated into the EEA Agreement.

(4)Annex II and Protocol 37 to the EEA Agreement should therefore be amended accordingly.

(5)The position of the Union within the EEA Joint Committee should therefore be based on the attached draft Decision,