Commission Implementing Regulation (EU) 2024/2699 of 18 October 2024 laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices

The European Commission has implemented a regulation amending Implementing Regulation (EU) 2022/1646. The new regulation aims to improve the national risk-based control plans and the national randomised surveillance plan for the management of pharmacologically active substances.

The amended regulations include additional content, such as the species to be sampled, the place of sampling, national legislation on the use of these substances, and competent authorities responsible for implementation.

Member States are required to provide more detailed information in their control plans and surveillance plan, including justifications for the selected substances and matrices included in the plans.

The regulation also includes changes to the submission and evaluation process of the national risk-based control plans and the national randomised surveillance plan by the Member States. They must transmit data to the European Food Safety Authority (EFSA) on a specific date and ensure that it is valid, reviewed, and accepted before August 31st.

Additionally, there are provisions for controls on specific combinations of Group A substances and commodity groups as listed in Annex II to Delegated Regulation (EU) 2022/1644.

This regulation comes into effect on the twentieth day following its publication in the Official Journal of the European Union and applies from January 1st, 2025.