CRED 8 Presentations

01/07/2024

European Medicines Agency (EMA)

• EU decentralised agency responsible for scientific evaluation, supervision and safety monitoring of medicines in the EU

• Founded in 1995

• Located (since 2019) in Amsterdam

• Reg. (EC) No 726/2004

[previously Reg. (EEC) No 2309/93/EC]

• Scientific secretariat responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products *

• * Art. 55 of Reg. (EC) No 726/2004 15

The Organisation for Professionals in Regulatory Affairs

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EMA – new tasks as of 1 March 2022 (and later)

• 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 published on 31 January 2022 has come into force 1 March 2022 except for:

 Medical devices shortages : 2 February 2023  the European Shortages Monitoring Platform (ESMP): 2 February 2025

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The Organisation for Professionals in Regulatory Affairs

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