New EU pharmacovigilance rules come into force

Published: 25-Jun-2013
Regulatory

Also asks for comments on draft pharmacovigilance advice on managing and reporting adverse reactions to medicinal products


New European Union (EU) pharmacovigilance legislation is now in place telling medicine marketing-authorisation holders to inform the European Medicines Agency (EMA) why they withdraw a medicine from sale. The same applies to requests to withdraw a marketing authorisation and a plan not to apply to renew such permissions.

This rule applies to EU marketing authorisations from 5 June, and will apply to nationally authorised medicines from 28 October.

Meanwhile, EMA has asked for comments on new draft pharmacovigilance advice on managing and reporting adverse reactions to medicinal products. This focuses on the management and reporting of suspected adverse reactions during non-interventional studies.

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