CHMP

CHMP - Committee for Medicinal Products for human use

The Committee for Medicinal Products for Human Use (CHMP) is responsible for preparing the Agency's opinions on all questions concerning medicines for human use, in accordance with Regulation (EC) No 726/2004.

The CHMP plays a vital role in the marketing procedures for medicines in the European Union:
In the ‘centralised’ or ‘Community’ procedure, the CHMP is responsible for conducting the initial assessment of medicines for which an EU-wide marketing authorisation is sought. The CHMP is also responsible for several post-authorisation and maintenance activities, including the assessment of any modifications or extensions (‘variations’) to an existing marketing authorisation.


In the ‘mutual-recognition’ and ‘decentralised’ procedures, the CHMP arbitrates in cases where there is a disagreement between Member States concerning the marketing authorisation of a particular medicine (‘arbitration procedure’). The CHMP also acts in referral cases, initiated when there are concerns relating to the protection of public health or where other Community interests are at stake (‘Community referral procedure’).

The CHMP plays an important role in this EU-wide ‘pharmacovigilance’ activity by closely monitoring reports of potential safety concerns (‘adverse drug reaction reports’, or ADRs) and, when necessary, making recommendations to the European Commission regarding changes to a medicine’s marketing authorisation, or its suspension/withdrawal from the market.

The CHMP publishes a a European public assessment report (EPAR) for every centrally authorised medicine that is granted a marketing authorisation.

Other important activities of the CHMP and its working parties include:

  • the provision of assistance to companies researching and developing new medicines;
  • the preparation of scientific and regulatory guidelines for the pharmaceuticals industry;
  • cooperation with international partners on the harmonisation of regulatory requirements for medicines.

 

for further information visit CHMP page

Created: 07.10.2010 | Page last modified: 18.02.2011

© Austrian Federal Office for Safety in Health Care
to top