CRED ERP 25

01/07/2025

European Medicines Agency (EMA)

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

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Founded in 1995

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Located (since 2019) in Amsterdam

• Reg. (EC) No 726/2004* [previously Reg. (EEC) No 2309/93/EC] Art . 55 of Reg. (EC) No 726/2004

• 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* • Works together with the EU Members states but also with regulatory authorities internationally/ globally

* Article 55 and 56 of Reg. (EC) 726/2004 17

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: came into force on 2 February 2023

➢ the European Shortages Monitoring Platform (ESMP): came into force 2 February

2025 and is running

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The Organisation for Professionals in Regulatory Affairs

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