MEDICINE MARKETING AUTHORISATION VARIATION REGULATION PROPOSED BY EUROPEAN COMMISSION
July 1st, 2008
BY KEITH NUTHALL
A EUROPEAN Union (EU) regulation laying down clear procedures for pharmaceutical manufacturers needing to vary the terms of their market approvals for particular medicines has been proposed by the European Commission.
The legislation would build upon the existing EU market approval regulations EC/1084/2003 and EC/1085/2003.
The reform has been prompted by concerns that the existing system for handling changes in marketing authorisation was cumbersome. A Commission memorandum on the reform said it was "appropriate...to establish a simpler, ...
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