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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

06/08/2020

Coronavirus – Evaluation of the use of saliva samples as an alternative to sampling via a deep nasal swab to detect SARS-CoV-2, the virus that causes COVID-19

30/07/2020

Coronavirus - Derogation for COVID-19 clinical trials of medicinal products containing or consisting of genetically modified organisms

10/07/2020

Coronavirus: FAMHP adds dexamethasone to the list of medicinal products subject to controlled distribution measures

10/07/2020

Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages

All news

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