“The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency’s (EMA) committee responsible for human medicines. The CHMP plays a vital role in the authorisation of medicines in the European Union (EU). 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.”
Source: Committee for Medicinal Products for Human Use (CHMP)
