Secrecy and transparency of medicines licensing in the EU

From Jan 1, 1998, new medicines marketed in more than one EU country have to be licensed in one of two ways. First, the EU's mutual recognition procedure enables manufacturers to seek simultaneous marketing authorisation in concerned member states (CMSs; see panel for explanation of abbreviations), provided that they already have marketing authorisation for that drug in at least one member state, known as the RMS. Under this procedure, the CMSs are encouraged to recognise the marketing authorisation of the RMS. However, if they do not, the matter is referred to the European Commission's scientific advisory body, the CPMP, for arbitration. If the CPMP's advice is accepted by the Commission it is binding on the CMSs and the RMS.