CRED ERP 25

01/07/2025

⚫ Update to ongoing Pharmaceutical legislation

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New proposal Pharma Legislation EC

➢ On 26 April 2023 the EC has published a proposal for revision of Pharma legislation: • New Directive (= revision Directive 2001/83/EC • New Regulation (Revision and combining current regulations on Centralised procedures/EMA Governance/Paediatric and Orphan Regulation) • Council Recommendation on AMR (antimicrobial resistance) ➢ These proposals have been drafted also based on input from EMA/EU NCAs and other stakeholders

Current status: trilogue phase has started!

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