In its capacity as the competent national authority, the FAMHP is actively engaged at a European level. In the context of its international activities, the agency keeps developing its network of European partnerships.
The FAMHP performs evaluation, control, inspection and authorisation activities on behalf of the European Medicines Agency (EMA). The FAMHP also works jointly with competent authorities of other European Union Member States through the Heads of Medicines Agency (HMA).
Furthermore, Belgium is strengthening its collaboration with neighbouring countries in matters regarding medicines and health products.
- In 2018, Belgium and the Grand Duchy of Luxembourg formalised their joint declaration of 4 July 2016 (Gäichel IX) with a cooperation agreement intensifying their collaboration. FAMHP inspectors are now authorised to carry out joint inspections of manufacturers and (wholesale) distributors of medicinal products with inspectors from Luxembourg’s Division de la Pharmacie et des Médicaments (pharmaceutical and medicines division – DPM), on Luxembourg territory.
- In France, Mr Xavier de Cuyper, CEO of the FAMHP, was appointed to the Board of Directors of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicine and Health Products – ANSM). The Board of Directors establishes the policy directions of the ANSM.
- Also in France, the ANSM recently set up a Comité d’information des produits de santé (health product information committee – CIPS). Ms Jamila Hamdani, head of the Pharmacovigilance unit (human use)/Evaluation at the FAMHP’s Directorate General POST authorisation, represents the agency there. The committee is dedicated to information and communication issues relating to health products. Its mission is to offer innovative solutions for the ANSM and to participate in implementing them. The multidisciplinary committee brings together representatives of patient associations, health professionals, foreign agencies and experts.
- The FAMHP is currently exploring new areas for collaboration and synergy with Luxembourg and the ANSM regarding medical devices and the unavailability of medicinal products.