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 aim of Pharmacovigilance is 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.
NTC undertakes to collect, process and evaluate all safety information related to the risk/benefit profile of its products.
European Legislation on Pharmacovigilance requires all healthcare professionals and citizens to report any suspected adverse reactions.
Reporting Adverse Reactions in Italy
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 available on the national territory.
The reporting form for healthcare professionals is a simple and practical tool to report adverse events relating to any drugs. Reports are entered into the RNF allowing the instant monitoring of adverse reactions.
Patients, prescribers, healthcare professionals, and pharmaceutical companies may report the occurred adverse reaction(s) through their healthcare professionals, as reported in the Italian AIFA website, but citizens may also report through the completion of the proper citizen’s reporting form or by means of the VigiFarmaco tool recently activated to report spontaneous adverse events.
The reporting of Adverse Event 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 drug adverse reaction.
For any Pharmacovigilance issue you may contact the NTC Pharmacovigilance staff by completing the form here