Member State [MS]

The EMA Committee for Orphan Medicinal Products (COMP) reviews applications for orphan-medicinal-product designation.

Before a medicinal product can be marketed and sold, a marketing authorisation must be obtained from the relevent National Competent Authorities. The marketing authorisation application process can take one of two paths - the decentralised procedure, or the centralised procedure. In some cases in Europe, the centralised procedure is mandatory.