News FAMHP

From 6 to 13 November 2023, the FAMHP is taking part in the worldwide #MedSafetyWeek campaign, a cooperation between medicines regulators from more than 80 countries and several non-governmental organisations. The goal is to raise awareness about the importance of reporting side effects of medicines.

Glucagon-like peptide-1 (GLP-1) analogues are in increasing demand worldwide. The limited availability of some of these drugs will last in Belgium until June 2024. Experts from the FAMHP's Unavailability Task Force issue the following recommendations.

Marketing authorisation holders have until the end of February 2024 to submit annual sales volume data for veterinary medical products for 2023.

During the end-of-year period, the FAMHP will be closed from Monday 25 December 2023 to Monday 1 January 2024. Deadlines have been set for the submission of different types of dossiers.

On 16 October 2023, the Data Tracking System (DTS) dossier will go live within the FAMHP. This application replaces four MeSeA applications. DTS provides additional functionalities that facilitate the effective management of dossiers in the context of marketing authorisation and vigilance.

During the October 2023 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency, recommends an update to the product information for medicines containing omega-3-acid ethyl esters, to inform healthcare professionals and patients of the risk of atrial fibrillation.

There is limited availability of the medicine Ozempic (semaglutide-based solution for subcutaneous injection) due to an acute increase in demand. This limited availability will certainly last until early 2024. Rybelsus (semaglutide-based tablets) is also unavailable. The experts from the FAMHP's Unavailability Task Force adapt the recommendations.

In the fight against antimicrobial resistance (AMR), it is important to improve the diversity of therapeutic treatments to enable medical doctors to make the most appropriate choice. A new dosage for children has recently been launched on the Belgian market for a pheneticillin-based antibiotic and two antivirals, one composed of bictegravir, emtricitabine and tenofovir and the other composed of dolutegravir, abacavir and lamivudine.

The supply of high-dose methotrexate, used in oncology, was temporarily limited worldwide. The situation has since returned to normal, allowing the task force's recommendations to be lifted.

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