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Secrecy and transparency of medicines licensing in the EU
journal contribution
posted on 2023-06-08, 09:41 authored by John Abraham, Graham LewisFrom 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.
History
Publication status
- Published
Journal
LancetISSN
0140-6736Publisher
ElsevierExternal DOI
Issue
9126Volume
352Page range
480-482Pages
3.0Department affiliated with
- Sociology and Criminology Publications
Full text available
- No
Peer reviewed?
- Yes