Safety Monitoring
GR Farma is equipped with a pharmacovigilance system and it is committed to collect, process and evaluate all the information about safety concerning the risk-benefit profile of its own products.
Any adverse reaction related to our products, represents an important source of information for the pharmacovigilance activities, and allows the detection of potential safety signals related to the use of the pharmaceutical product.
What is Pharmacovigilance?
Pharmacovigilance is the set of activities related to the detection, evaluation, monitoring and prevention of adverse reactions to pharmaceuticals or any other issue associated with their use.
The main goals of Pharmacovigilance are to improve patient health and safety with respect to the use of pharmaceutical products and to support public health programmes providing reliable and prompt information for the ongoing evaluation of drugs risk-benefit profile.
The European legislation on Pharmacovigilance imposes on all healthcare professionals and citizens to report any suspected adverse reaction.
What is an adverse reaction to a drug?
It is an harmful and unintended response to:
Intended use
Use of the pharmaceutical product in compliance with the authorised indications
Professional use
Exposure due to professional reasons
Improper use
Use of the pharmaceutical product not compliant with the authorised indications, including off label use, over dosage, improper use, misuse and therapeutic error
Information on how to report adverse reactions to drugs in Italy
The voluntary reporting of suspected adverse reactions can be carried out both by citizens and healthcare professionals, according to one of the following procedures:
- by filling out the suspected adverse reaction report form: CLICK HERE to retrieve it
- by filling out the i ADVERSE REACTION REPORT FORMS | AGENZIA ITALIANA DEL FARMACO (aifa.gov.it)
- by sending them to the Pharmacovigilance Authority of the healthcare facility to which you belong, via e-mail or fax CLICK HERE for contact details or RESPONSABILI DI FARMACOVIGILANZA | AGENZIA ITALIANA DEL FARMACO (aifa.gov.it)
- or directly online through the Website VIGIFARMACO.IT or VIGIFARMACO following the step-by-step procedure.
In other European countries or Extra-EU countries:
In other European countries or Extra-EU countries, the adverse reaction reporting is subject to local national requirements.
Please contact the healthcare professional in your countries to properly report any adverse reaction to pharmaceutical products.
In case of pharmacovigilance issues
Please contact the GR Farma Pharmacovigilance staff by filling out the form on the right