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Materiovigilance

Materiovigilance

What shall be notified?

Who should notify?

When must incidents be notified?

How should incidents be notified?

Last updated on 20/05/2009

Notification of adverse reactions or incidents

PIL and SPC
of a medicine

(PIL: patient information leaflet SPC: summary of product characteristics)

News

19/11/2018

Make medicines safer by reporting side effects in children or during pregnancy or breast feeding. The FAMHP again participates in an international campaign to emphasize the importance of reporting side effects.

16/11/2018

Update on the new Clinical Trial Regulation pilot project

16/11/2018

Publication of the update of the Guidance for submission of CTA initial dossiers, substantial amendments and end of trial notifications to the FAMHP

16/11/2018

Antibiotic Awareness Week: working together to reduce anti-microbial resistance.

All news

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