European Public Assessment Report (EPAR) | PharmaBharat Tools

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European Public Assessment Report (EPAR) | PharmaBharat Tools

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Committee for Advanced Therapies(CAT)Centralised Procedure Committee for Medicinal Products for Human Use(CHMP)Coordination Group for Mutual Recognition and Decentralised Procedures (Human)(CMDh)Concerned Member State(CMS)Co-Rapporteur Committee for Orphan Medicinal Products(COMP)Decentralised Procedure(DCP)European Commission Decision European Public Assessment Report(EPAR)Marketing Authorisation Holder(MAH)Mutual Recognition Procedure(MRP)National Competent Authority(NCA)Paediatric Committee(PDCO)Paediatric Investigation Plan(PIP)Pharmacovigilance Risk Assessment Committee(PRAC)Rapporteur Referral Procedure Reference Member State(RMS)

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RA EU Procedures & CommitteesEuropean Public Assessment Report

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European Commission Decision Marketing Authorisation Holder (MAH)

European Public Assessment Report(EPAR)

EU Procedures & Committees

Definition

A public document describing EMA’s assessment of a medicine authorized via the centralised procedure, including key benefits/risks and scientific considerations.