In view of the increase in cases of opioid abuse and dependence reported in recent years, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has decided to reinforce the messages aimed at limiting these risks in the SPCs and patient information leaflets.
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.
During its November 2023 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that the available evidence does not support a causal association between the glucagon-like peptide-1 (GLP-1) receptor agonists - exenatide, liraglutide, dulaglutide, semaglutide, and lixisenatide - and thyroid cancer.
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.