CRED 8 Presentations

01/07/2024

European Commission (2/2) • Adopts decision on granting: •

Marketing authorisations in the centralised procedure

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Orphan designations

• Certain referrals and other procedures affecting NAPs

International cooperation

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The Organisation for Professionals in Regulatory Affairs NB: Recently the EC has published a proposal for revision of Pharma legislation: New Directive and new Regulation plus Council Recommendation on AMR These proposals have been drafted also based on input from EMA/EU NCAs and other stakeholders 11

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EU legislation- which EU institutions involved?

 the European Parliament, which represents the EU’s citizens and is directly elected by them; has legislative, supervisory, and budgetary responsibilities  the Council of the European Union, which represents the governments of the individual member countries (“voice” of EU member governments, adopting EU laws and coordinating EU policies). The Presidency of the Council is shared by the member states on a rotating basis (current Presidency = Hungary).  the European Commission (a team or 'College' of Commissioners, 1 from each EU country), which represents the interests of the Union as a whole and promotes the general interest of the EU by proposing and enforcing legislation as well as by implementing policies and the EU budget

The Organisation for Professionals in Regulatory Affairs 12

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