Pharmacovigilance is a series of activities aimed at continuously evaluating all information related to the safety of medicinal products and to ensure, for all medicinal products on the market, a favorable benefit/risk ratio for the population. It includes a range of activities involving the Institutions (AIFA), the marketing authorisation holders of medicinal products, local health authorities and healthcare personnel.
The first three actors are connected to each other in a network, the National Pharmacovigilance Network. The contribution of citizens is essential in the pharmacovigilance machine to ensure operation of the whole system. In the context of pharmacovigilance, the holder of the marketing authorisation for the medicinal products has the legal obligation to record in detail all suspected adverse reactions observed in Italy, the European Union or another country.
What is an adverse reaction?
An adverse reaction is any harmful and undesirable effect related to the use of a medicine.
What to do in case you think you have had an adverse reaction to a medicinal product
First contact your doctor and tell him what happened. If you also want to report what happened, please follow the instructions below.
You can also report directly to local Head of Pharmacovigilance, following the instructions on the Health Authority’s website (AIFA, Agenzia Italiana del Farmaco).
If you have taken a Junia Pharma drug and wish to report an adverse reaction to Junia Pharma’s drug safety manager, you can fill out the appropriate form by clicking here.
The following information is required in order to make the report:
- Subject/patient who has experienced the adverse reaction: first and last name initials, gender, age, city of residence
- Junia Pharma medicinal product: name of the medicinal product taken
- Adverse effect: description of the effect
- Reporter: name and surname of the person reporting, email and profession
notice and consent pursuant to Legislative Decree 196/2013.