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Last updated on 11/01/2009

Notification of adverse reactions or incidents

PIL and SPC
of a medicine

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

News

15/05/2018

Update on the new Clinical Trial Regulation pilot project

15/05/2018

New guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the R&D (human) Division of the FAMHP.

14/05/2018

Flash VIG-news: PARACETAMOL - Reminder of the correct posology and precautions

14/05/2018

Adaptation of RMA approval procedure

All news

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