Module 1 2021

30/06/2021

 National Authorities in each Member State; ● Exact Roles and Tasks differ between countries ● Network through Heads of Medicines Agencies; Competent Authorities

 CMDh (Commission for Mutual Recognition and Decentralised Procedure (human) ; ● Examination of any query related to a marketing authorisation of a medicinal product in 2 or more member states. ● Representatives of all EU MSs plus Norway, Iceland and Lichtenstein – EU Law applies in the UK only to the territory of Northern Ireland

The Organisation for Professionals in Regulatory Affairs

5

 Protection and Promotion of Public and Animal Health  Marketing Authorisations  EU’s safety-monitoring or ‘pharmacovigilance’ system  Referrals  Coordinating inspections: GMP, GCP, GLP, PhV  Stimulating Innovation and research ● Scientific Advice, Guideline, Small Medium Enterprises Office, Orphan Designations, Innovation Task Force, PRIME designation; The European Medicines Agency

The Organisation for Professionals in Regulatory Affairs

6

3