Pharmacovigilance services in Belgium

The Belgian Centre for Pharmacovigilance (BCPH) is responsible for coordinating various pharmacovigilance Services in Belgium. BCPH is part of a European network of pharmacovigilance, called EudraVigilance. BCPH is responsible for collecting and evaluating: periodic pharmacovigilance reports, patient safety data during clinical trials involving medicines to be authorized in Belgium, individual reports about undesirable reactions submitted by healthcare professionals and marketing authorization holders (MAHs). It is also responsible for overseeing pharmacovigilance inspections to prevent & mitigate risk and evaluate risk management plans and pharmacovigilance Services Health professionals can report ADRs by filling in the yellow card and sending it by post, or they can also submit an ADR online. The mutual recognition of quality based on quality labels is essential to allow competent medicines authorities within the European Union (EU) to put confidence in each other. The Federal Agency for Medicines and Health Products (FAHMP) works with a Total Quality Management system (TQM). MAHs should appoint Qualified Person in Pharmacovigilance (QPPV) to oversee and coordinate the pharmacovigilance activities. If the QPPV is not located in Belgium, the MAH must appoint a local contact person for Belgium and inform the FAMHP. This includes better ADR analysis methods and simplifying ADR reporting procedures to make them more user-friendly thereby encouraging all relevant stakeholders to report ADRs to strengthen quality system and improve risk management.

As a leading global contender, DDReg understands the significance of patient safety right from spontaneous to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in Belgium, including adverse drug reaction reporting, signal detection & management, aggregate report writing, and of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.