The European Medicines Agency (EMA) is the authority responsible for the centralised authorisation procedure. The scientific assessment of the application documentation, with regard to quality, efficacy and safety, is conducted by the Committee for Medicinal Products for Human Use (CHMP). Through this committee, scientists from all of the European licensing authorities are involved in processing and assessing applications. The CHMP draws up a scientific expert opinion based on the assessment and issues a recommendation on the granting of a marketing authorisation. This recommendation forms the basis of the decision by the EU Commission, which is responsible for issuing the marketing authorisation.
Organiser: Federal Ministry of Health