Pharmacovigilance

Every new medicine has been extensively tested before it is brought to market. But some (rare) side effects only come to light when a medicine is already for sale (for some time). Pharmacovigilance detects, analyses and prevents medicine side effects.

Patients and health care providers: reporting side effects
Are you a patient? Or are you a doctor, pharmacist, dentist, nurse or midwife … ?
Help the FMHP protect patients and make medicines as safe as possible. Report side effects.

Manufacturers and governments: monitor medicines
Marketing authorisation holders (MAs) for medicines for human use and governments of European Union member states have got specific obligations.

  • Marketing authorisation holders must appoint a responsible person for pharmacovigilance.
  • Marketing authorisation holders must record all reported side effects, create detailed reports and send them to EudraVigilance, the European medicine database.
  • Marketing authorisation holders must submit periodic safety reports (periodic pharmacovigilance reports) updated at set times to the FAMHP’s Vigilance Division.
  • EU member states must create a pharmacovigilance system. In addition, they must motivate doctors and other health care professionals to report side effects via that system.
  • European Pharmacovigilance must ensure the exchange of information about side effects and the safety of medicines between EU member states and pharmaceutical companies.

Protect patients by detecting side effects
Medicine surveillance protects patients.

  • By detecting unknown or insufficiently documented side effects and interactions with other medicines as quickly as possible.
  • By seeing whether a known side effect occurs more often than before.
  • By identifying risk factors and mechanisms that are the basis of side effects.
  • By permanently monitoring the relationship between risks and advantages of medicines and assessing them.
  • By disseminating information on side effects and interactions with medicines so they occur less and fewer medication errors take place.

Active pharmacovigilance
The FAMHP participates in “active pharmacovigilance” by extensively informing health care professionals on the latest news on medicine surveillance and by making reporting side effects it as easy as possible. The FAMHP doesn't just want to receive more side effects reports, we also want to improve these reports’ quality.

Do you want to request an information session or do you have a question or proposal about (active) medicine surveillance? Send them in an e-mail to ADR@fagg.be

Last updated on 31/01/2020