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Italian Medicines Agency Agenzia Italiana del Farmaco

Adverse Reactions to medicinal products

How to report an adverse reaction

The reports of suspected adverse reactions (Adverse Drug Reactions, ADRs) to drugs and vaccines allow the detection of potential alert signals relating to the use of medicines, to make them safer for the benefit of all patients.

The EU pharmacovigilance legislation requires all healthcare professionals and citizens to report any suspected adverse reactions (serious and not serious, known and not known).

You can report a suspected adverse reaction in one of the following ways:

  • By filling in the reporting form and sending it via e-mail to the Pharmacovigilance contact point of your facility, or to the Marketing Authorization Holder (MAH) of the drug suspected to have caused the adverse reaction;
  • Online on the AIFA website. 

 

You can report suspected adverse reactions relating to the use of dietary supplements, herbal products, magistral preparations (e.g., cannabis-based for medical use), homeopathic medicines (not registered as medicines) and other products of natural origin, on the VigiErbe online phytovigilance system (www.vigierbe.it).

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