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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

26/05/2020

PRAC May 2020 – New measures to avoid handling errors with Leuprorelin depot medicines and completion of signal evaluation for ibuprofen, ketoprofen and fixed-dose combinations

20/05/2020

Postponement of the European regulation for medical devices due to of COVID-19

12/05/2020

Coronavirus: updated Belgian directive for the reuse of surgical and FFP2/FFP3 face masks during the COVID-19 pandemic

12/05/2020

Coronavirus: good practices when changing consumables used with COVID-19 patient ventilators

All news

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