Pharmacovigilance is the set of activities aimed at identifying, assessing, understanding and preventing adverse effects or any other problem related to the use of medicinal products, to ensure a favorable benefit/risk ratio for the population.

In line with this general definition, the objectives underlying pharmacovigilance, in accordance with current European legislation, are:

  • to prevent damage caused by adverse reactions resulting from the use of a medicinal product according to the authorization conditions but also to therapeutic errors, professional exposure, non-compliant uses including misuse and abuse.
  • promote the safe and effective use of medicinal products, by providing timely information on the safety of medicines to patients, health professionals and the public.

Pharmacovigilance is therefore an activity that contributes to the protection of public health.

Data on drug safety can be obtained from different sources: Reports of suspected adverse reactions (spontaneous or not), by citizens or doctors, clinical studies, scientific literature, reports sent by pharmaceutical companies, etc.

(Source AIFA)
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