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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 Lewis
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.

History

Publication status

  • Published

Journal

Lancet

ISSN

0140-6736

Publisher

Elsevier

Issue

9126

Volume

352

Page range

480-482

Pages

3.0

Department affiliated with

  • Sociology and Criminology Publications

Full text available

  • No

Peer reviewed?

  • Yes

Legacy Posted Date

2012-02-06

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