Vigilance Division (Pharmaco, Materio, Haemo, Bio)

Division/Coordination/Unit

Vigilance Division

General e-mail address

vig@fagg-afmps.be

 

General phone number

+32 2 528 43 75

Key tasks

  • Collection and evaluation of:
    • individual reports of adverse reactions to medicines for human and veterinary use. These reports are submitted by MAHs, healthcare professionals and patients
    • signals of adverse reactions to medicines for human and veterinary use
    • PSURs for medicines for human and veterinary use
    • RMPs for medicines for human and veterinary use
    • incidents after using medical devices
    • information about serious adverse events and reactions with blood and blood components
    • information about serious adverse reactions and events with MLM-MCH
  • Participation in the evaluation of applications for five-yearly renewals for medicines for human and veterinary use
  • Participation in activities relating to the vigilance in the European context for medicines for human and veterinary use
  • Dissemination of information about vigilance for the attention of healthcare professionals and the public
  • Implementation of measures proposed following evaluation of pharmacovigilance data for medicines for human and veterinary use
  • Implementation of measures proposed following evaluation of data about materiovigilance, haemovigilance and biovigilance
Last updated on 09/09/2019