Drug manufacturers asked to help develop new urgent pharmacovigilance policy

Published: 23-Feb-2009

The Europe Commission has asked Europe"s pharmaceutical sector for advice on whether changes are required to the EU"s pharmacovigilance guidelines for urgent problems involving medicines.


The Europe Commission has asked Europe’s pharmaceutical sector for advice on whether changes are required to the EU’s pharmacovigilance guidelines for urgent problems involving medicines.

Brussels wants these views ahead of a planned incorporation of this guidance in the EU’s Eudra-Lex database – its compendium of EU rules and guidelines for the pharmaceutical industry.

The Commission has released a detailed assessment of existing advice, highlighting issues such as the immediate circulation of pressing problems, notably using the ‘rapid alert’ system; the role of the EMEA’s committee for medicinal products for human use (CHMP); and the national revocation or variations of existing marketing authorisations.

Contributions should be sent to entr-pharmaceuticals@ec.europa.eu by 3 April.

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