Regulatory and Pharmacovigilance Services
Pharmacovigilance
Proge Medica has in place a Pharmacovigilance System and undertakes to collect, process and evaluate all safety information related to the risk/benefit profile of its products.
Any adverse reaction related to our pharmaceutical products is an important source of information for the pharmacovigilance activities, allowing the detection of potential safety signals associated with the use of the drug.
What is Pharmacovigilance?
Pharmacovigilance is the science and activities relating to the collection, detection, assessment, monitoring, and prevention of adverse effects or any other drug-related problems.
The main aims of Pharmacovigilance are to enhance patient care and patient safety in relation to the use of medicines and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
European Legislation on Pharmacovigilance requires all healthcare professionals and citizens to report any suspected adverse reactions.
What is an Adverse Drug Reaction?
A response to a medicinal product which is harmful and unintended. Adverse Drug Reactions may arise from:
- The use of the product within the terms of the marketing authorization
- Occupational exposure
- The use of the product outside the terms of the marketing authorization including off-label use, overdose, misuse, abuse and medication error.
Information for Reporting Adverse Reactions
In Italy:
The reporting of spontaneous suspected adverse reactions can be performed by both Citizens and Healthcare Professionals, according to one of the following methods:
- completing the report form of suspected adverse reaction (electronic or paper) and sending it to the Local Pharmacovigilance Responsible person of the Territory by e-mail or fax to the contacts reported at agenziafarmaco.gov.it
- or directly online at vigifarmaco.it following the reported procedure.
In the other EU or extra-UE countries:
The reporting of Adverse Reactions in the other European or extra-EU countries is subject to the local national requirements. Please contact the Healthcare professionals in your Country to properly report any Adverse Drug Reaction.