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Image header Agence Europe
Europe Daily Bulletin No. 10324
Contents Publication in full By article 22 / 39
GENERAL NEWS / (eu) eu/medicines

Debate on next step after mediator issue

Brussels, 25/02/2011 (Agence Europe) - French Minister for Employment and Health Xavier Bertrand and the European Health Commissioner John Dalli met in Brussels on Friday 25 February. At a brief press conference, the commissioner said that he had asked his staff to use the example of Mediator as a “stress test” to assess whether problems of the same type could still be a possibility, further to recent changes to the rules on pharmacovigilance and if so, to propose solutions to remedy them. The French minister called for the conditions for market authorisation to be granted by the European Medicines Agency to be reviewed in order to ensure that a member state can request that a drug is subjected to comparative studies with a reference drug and/or trials using a placebo. Commissioner Dalli indicated his willingness to work with France, whilst stressing that bringing in the possibility of additional tests by request of a member state would have to be looked into in the light of its implications for the whole of the drugs authorisation system in Europe. (O.J./transl.fl)

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