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Pharmacovigilance Risk Assessment Committee (PRAC)

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee is responsible for assessing and monitoring safety issues for human medicines; it is the successor to the Pharmacovigilance Working Party (PhVWP) of the Committee for Medicinal Products for Human Use (CHMP).

Aside from representatives of the 27 EU Member States (including representatives from the BfArM) as well as from Iceland and Norway, independent scientific experts, healthcare professionals and patient organisations are also represented in the PRAC. The PRAC meets monthly at the EMA in London.

Further information regarding the PRAC can be found on the homepage of the European Medicines Agency (EMA).

Agendas and reports of the PRAC are also published there (PRAC: Agendas, minutes and highlights).

The recommendations of the superseded Pharmacovigilance Working Party (PhVWP) of the Committee for Medicinal Products for Human Use (CHMP) can also be found on the EMA's homepage.