Belgium introduces synchronised procedure guidance for combined clinical trials with medicinal products and device performance or clinical investigations.
FAMHP (Belgian Medicine Agency) · BelgiumFrom 1 September 2026, applicants must use new eAF version 1.28.0.0, aligned with ISO IDMP model and Veterinary Regulation 2019/6.
FAMHP (Belgian Medicine Agency) · BelgiumSince 1 July 2026, animal species must be specified on veterinary prescriptions under the new mandatory model.
FAMHP (Belgian Medicine Agency) · BelgiumImplementing Regulation (EU) 2026/1810 updates the list of essential substances for food-producing horses, entering into force 28 July 2026, with transition until 21 May 2027.
FAMHP (Belgian Medicine Agency) · BelgiumFAMHP and AMCRA offer e-learning to support veterinarians in recording antibiotic use in horses and aquaculture fish via VAMREG from 1 July 2026.
FAMHP (Belgian Medicine Agency) · BelgiumFAMHP reminds patients and healthcare professionals of rational use recommendations for benzodiazepines and related medicines following WOREL guideline publication.
FAMHP (Belgian Medicine Agency) · BelgiumDocument clarifies distinction between revision date and approval date in product information for human medicinal products.
FAMHP (Belgian Medicine Agency) · BelgiumFAMHP launches BioVigilance, an online application for reporting serious adverse events and reactions related to reproductive and non-reproductive substances of human origin intended for human application.
FAMHP (Belgian Medicine Agency) · BelgiumIn order to guarantee a high standard of safety and quality in gamete donations in Belgium and to strengthen the supervision of fertility centres in the long term, the Federal Agency for Medicines and Health Products ...
FAMHP (Belgian Medicine Agency) · BelgiumFAMHP updates on pending EU legislative initiatives including the Biotech Act, MDR/IVDR revision, Critical Medicines Act, pharmaceutical legislation and online health information measures.
FAMHP (Belgian Medicine Agency) · BelgiumPRAC completed review of valproate safety signal and recommended new safety information for Ixchiq chikungunya vaccine.
FAMHP (Belgian Medicine Agency) · BelgiumFAMHP publishes information on quota exceedances involving foreign gamete donors and emphasises its commitment to transparency and ongoing monitoring.
FAMHP (Belgian Medicine Agency) · BelgiumEMA Pharmacovigilance Risk Assessment Committee initiated review of injectable iron medicines for hypophosphataemia and bone-related adverse effects.
FAMHP (Belgian Medicine Agency) · BelgiumFAMHP alerts to medication error risk from varied vitamin D3 product strengths and dosages; overdose risk in infants, children and elderly.
FAMHP (Belgian Medicine Agency) · BelgiumEMA Pharmacovigilance Risk Assessment Committee recommended new safety information for desogestrel- and etonogestrel-containing contraceptives and Litfulo (alopecia areata).
FAMHP (Belgian Medicine Agency) · BelgiumNew version 1.28.0.0 of the Marketing Authorisation Application Form aligns product data with ISO IDMP model and reflects New Veterinary Regulation 2019/6 changes.
FAMHP (Belgian Medicine Agency) · BelgiumFAMHP launches VAMREG, a new application for mandatory collection of data on sales, use and supply of veterinary antibiotics in Belgium.
FAMHP (Belgian Medicine Agency) · BelgiumDistribution restrictions on Zypadhera have been gradually relaxed since 1 January 2026 as availability improves.
FAMHP (Belgian Medicine Agency) · BelgiumAzactam 1 g and 2 g powder are in very limited supply in Belgium; production not expected to resume before July 2027.
FAMHP (Belgian Medicine Agency) · Belgium