Federal Agency for Medicines and Health Products (FAMHP)

The number of temporarily unavailable medicines decreased in 2024: that is one of the main conclusions from the annual report of the Federal Agency for Medicines and Health Products. The year 2024 was also marked by the Belgian Presidency of the Council of the European Union. A unique opportunity for the FAMHP to strengthen its role at European level. At the same time, our other activities also continued. The FAMHP’s annual report provides an overview of that progress.

The annual biovigilance report includes all serious adverse events and reactions occurring during the treatment and use of substances of human origin from 1 January 2023 to 30 June 2024. In 2023, the reproductive system accounted for the majority of notifications.

In April 2024, the Critical Medicines Alliance was established under the Belgian Presidency of the Council of the European Union. The goal of the Alliance is to foster collaboration among policymakers and stakeholders, and develop a robust and responsive system for the supply of critical medicines in the European Union. Today, on 28 February 2025, the Critical Medicines Alliance presents its strategic report. This report will be used as the basis for new European legislation on medicines...

From 1 January 2024 to 30 June 2024, Belgium chaired the Council of the European Union, the body in which the 27 member states set the political direction and priorities of the European Union. During this period, the FAMHP organised over 20 events and meetings to promote cooperation and dialogue among member states and with European institutions. In addition, the FAMHP provided expertise to many important European initiatives. Time for a recap.

Although 2023 saw an increase in notifications regarding temporary unavailability of medicines, the agency once again demonstrated its effectiveness in ensuring the most efficient possible management of medicine stocks, as in the case of thrombolytics. The FAMHP also played its part in protecting public health by increasing the number of investigations into illegal medicines and devices by 30 %, and of inspections of pharmacies open to the public by over 40 %.

On 17 and 18 April, the Federal Agency for Medicines and Health Products (FAMHP), the National Institute for Health and Disability Insurance (NIHDI) and the Health Care Knowledge Centre (KCE) organised a high-level conference on health-related needs as drivers for healthcare policy and innovation. This conference was organised in the context of the Belgian presidency of the Council of the EU. The aim is to establish a research and innovation ecosystem that focuses on the most pressing health...

The FAMHP and Sciensano are warning about counterfeit ivermectin tablets that are being used for self-medication against COVID-19. Investigations show that these counterfeit ivermectin tablets are systematically underdosed or seriously contaminated with bacteria. In 2021, a total of 12 529 counterfeit ivermectin tablets originating from postal packages were seized. These tablets are regularly found in postal packages to this day.

In Belgium, each individual, after their death, is presumed to be a potential donor. Since 2020, as well as organ donation, any Belgian citizen has had the option to express their will, explicit consent or opposition to the post-mortem donation of human body material like skin, cartilage, tendons or heart values for transplantation, the manufacture of medicines (advanced therapies) and for scientific research.

Hugues Malonne appointed new FAMHP Chief Executive Officer by the federal government