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Re: Investor2014 post# 450995

Tuesday, 02/06/2024 2:35:50 PM

Tuesday, February 06, 2024 2:35:50 PM

Post# of 461833

The CHMP plays a vital role in the authorisation of medicines in the European Union (EU).

Centralised procedure
In the centralised procedure, the CHMP is responsible for:

conducting the initial assessment of EU-wide marketing authorisation applications;
assessing modifications or extensions ('variations') to an existing marketing authorisation;
considering the recommendations of the Agency's Pharmacovigilance Risk Assessment Committee on the safety of medicines on the market and when necessary, recommending to the European Commission changes to a medicine's marketing authorisation, or its suspension or withdrawal from the market.


"The time has come," the Walrus said, "To talk of many things:..."

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