Pending EC decisions

The European Medicines Agency (EMA) publishes information on medicines that have been evaluated by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) or the Medicinal Products for Veterinary Use (CVMP) and are currently pending a decision by the European Commission.

When a pharmaceutical company applies for marketing authorisation through the Centralised authorisation procedure, the CHMP or CVMP gives a positive or negative recommendation, in the form of a scientific opinion, on whether a medicine should be authorised. Immediately after the opinion is adopted, the EMA publishes a 'summary of opinion'. Search for:

This summary is replaced by a full European public assessment reports once the European Commission has decided - taking the EMA opinion into consideration - whether to grant the marketing authorisation.

Summaries of opinion are also published when the CHMP or CVMP adopts scientific opinions on important changes to an existing marketing authorisation applied for by the pharmaceutical company.

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