MEPs back pharmacovigilance legislation

Published: 6-Oct-2010
Regulatory

National web portals will be linked to central EU database


A network of pharmacovigilance websites will be set up across the European Union (EU) to spread information about medicines and their potential side effects.

National web portals linked to a central EU database, will include assessment reports, product characteristics summaries and patient information leaflets.

This follows the approval of new EU pharmacovigilance legislation by the European Parliament.

The legislation mandates that some medicines, such as those with a new active substance, will receive additional monitoring and be identified by a black symbol.

The new rules say the EU ‘Eudravigilance’ database will be the single point of receipt for all pharmacovigilance information from pharmaceutical companies and regulators.

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