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 to comply with relevant regulations and directives. We operate a pharmacovigilance system with quality assurance for all members of the Richter Group, which monitors any change in the benefit-risk ratio of medicines throughout their life cycle and informs authorities, healthcare professionals as well as patients of such a change.
Richter has been using an IT system complying with international standards for 10 years now to support the collection, transmission and analysis of information. Continuous monitoring is performed in line with the pharmaceutical authorities of the European Union, and the information is mutually shared in compliance with our statutory obligations.

At the Group level, over 9 500 reports were recorded and managed in our system in 2018, and nearly 12 000 in 2019.

The purpose of data collection and analysis is to identify the safety profile of medicines as accurately as possible so as to ensure that the use of the products is targeted as precisely as possible in terms of both indication and target population, primarily 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 product’s safety or can anticipate any circumstance that may expose society to an 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. In accordance with legal requirements, the Company employs a Qualified Person for Pharmacovigilance who oversees the operation of the pharmacovigilance system
and has personal responsibility for the adequacy of the system.

All employees regularly (yearly) receive pharmacovigilance training that provides basic knowledge.