Gedeon Richter is committed to treating pharmacovigilance as a high-priority area, looking at it as a service that aims to provide patients and physicians with the conditions for safe drug use and comply with relevant regulations and directives. At Gedeon Richter Romania, we operate a pharmacovigilance system that monitors any change in the benefit-risk ratio of Gedeon Richter medicines authorised in Romania, throughout their life cycle and informs authorities, healthcare professionals, as well as patients of such a change.

The purpose of data collection and analysis is to identify the safety profile of medicines as accurately as possible to ensure that the use of the products is targeted as precisely as possible in terms of both indication and target population, through improving the summaries of product characteristics, and patient information leaflets. The system is also designed to alert and intervene if it detects a change in the medicine’s safety or can anticipate any circumstance that may expose society to unforeseen risk.

Because no medicine is free of side effects, we believe that our activities, aimed at gaining the most precise understanding of the risk-benefit ratio of our medicines, protect both our patients and our products. We have expressed our commitment in our Pharmacovigilance Policy as well.

We perform our activity subject to quality assurance standards, in accordance with internationally accepted principles of Good Pharmacovigilance Practice. Responsibility for pharmacovigilance and the proper functioning of the system is overseen by the Qualified Person for Pharmacovigilance.