Pharmacovigilance
What does pharmacovigilance mean?
Pharmacovigilance is defined by the World Health Organisation as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. In compliance with European legislation, ERREKAPPA EUROTERAPICI operates its own pharmacovigilance system — a monitoring and reporting system used by the marketing authorisation holder and Member States to carry out the functions and fulfil the responsibilities identified in the relevant decree, aimed at monitoring the safety of authorised medicines and detecting any changes in their risk/benefit profile (Official Gazette No. 143 of 23 June 2015).
What is an adverse drug reaction?
An adverse reaction is defined as a harmful and unintended response resulting not only from the authorised use of a medicinal product under normal conditions, but also from medication errors and uses that do not conform to the terms of the marketing authorisation, including misuse and abuse of the medicine (Official Gazette No. 143 of 23 June 2015).
What to do in the event of an adverse drug reaction?
You should consult your doctor (providing all available details regarding the event and your clinical history) before taking any further action. If this is not possible, HERE you will find the form to complete and send to the responsible person’s email address. In addition, Errekappa Euroterapici S.p.A. provides an email address, a landline number, and a 24-hour mobile number for all matters relating to adverse drug reaction reports.
If you are a healthcare professional making a report, click HERE.
To report an adverse drug reaction or any side effect following the administration of an Errekappa Euroterapici pharmaceutical product, please contact the following:
Safety
Quality and safety are top priority for ERREKAPPA EUROTERAPICI and are ensured through rigorous quality-control and monitoring procedures, in compliance with European regulations and the guidelines of Good Manufacturing Practice (cGMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
Contact Us
Pharmacovigilance
Pharmacovigilance – Adverse Reaction Reporting (QPPV)
Email: fabianaauricchio@clinpharma copy to:farmacovigilanza@clinpharma.it
Mobile: +39 327 714 7494
