EU approves new pharmacovigilance rules

Published: 8-Oct-2012
Regulatory

Will come into force by December 2013


The European Union (EU) Council of Ministers and the European Parliament have agreed reforms to EU pharmacovigilance legislation.

Under the revisions, if a company decides not to renew a marketing licence for safety reasons, an emergency evaluation at the EU level would be staged. Also, when companies voluntarily withdraw a drug, they must declare if it is because of safety. And all drugs subject to post-authorisation safety studies will be labelled as such, to make patients aware.

The new rules will come into force by the end of 2013.

The Council said they ‘will lead to strengthened monitoring of additional categories of medicinal products’.

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