Module 1 2021

30/06/2021

Scientific Committees EMA

 Committee for Medicinal Product for Human Use (CHMP) and its working Parties • Tasks – Initial Assessment of EU Marketing Authorisation; Assessing Variations or extensions; Considers recommendation of the PRAC; Scientific Advice; Scientific Guidelines; Referrals; European Public Assessment Reports • Composition – Chair; Harald Enzmann (BfARM; Germany)) – 1 member plus alternate from 27 EU MSs; one member plus alternate from Iceland and Norway; 5 co-opted members;  Pharmacovigilance Risk Assessment Committee (PRAC)

 Committee Advanced Therapies (CAT)

 Committee for Orphan Medicinal products (COMP)

 Paediatric Committee (PDCO)

 Several Working Parties and Other Groups

The Organisation for Professionals in Regulatory Affairs

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 National • Application in individual countries;  Mutual Recognition (MRP)/Decentralised (DCP) Procedure • National Application intended for more than one country  Centralised Procedure • 1 application in all EU Member States • 1 marketing authorisation; • 1 (invented) name • 1 common product information How to obtain a marketing Authorisation

The Organisation for Professionals in Regulatory Affairs

8

4