On an exceptional basis during the COVID-19 pandemic, the FAMHP is authorising hospital pharmacies to organise deliveries of medicinal products directly to the homes of ambulatory patients who are unable to go to the hospital.
Coronavirus: delivery of medicinal products to ambulatory patients’ homes by the authorised hospital
Coronavirus: national guideline for the management of clinical investigations for medical devices during the coronavirus pandemic
The national guideline has been developed to assist sponsors of clinical investigations for medical devices in the management of these investigations in the context of the coronavirus pandemic.
Coronavirus: circular for care institutions on the (outsourcing of the) manufacture and reprocessing of medical devices and their accessories
In order to combat shortages of medical devices, care institutions have proceeded to manufacture medical devices and their accessories or to reprocess used medical devices. The FAMHP defines the modalities by means of a circular in order to offer more options to care institutions.
Coronavirus: Belgian directive for the reuse of surgical masks and FFP2/FFP3 masks in the context of the COVID-19 epidemic
A national guideline is available for the reprocessing of surgical masks and FFP2/FFP3 masks which allows reuse by cleaning, disinfecting or sterilising.
The FAMHP issues guidelines for checking the compliance and suitability of surgical face masks The guidelines are for companies not producing in accordance with European standards and for healthcare establishments and authorities ordering the masks.
In the fight against the new coronavirus, doctors are using medicinal products that were initially developed to treat other pathologies. The FAMHP summarises the actions and measures that have been taken.
Following the coronavirus epidemic (COVID-19), experts at FAMHP are actively monitoring the potential impact on the availability of medication and medical devices in Belgium. The FAMHP is also supporting the European Medicines Agency (EMA) in developing COVID-19 vaccines.
Jean-Michel Dogné, pharmacovigilance expert at the FAMHP, is appointed member of the World Health Organization's Global Advisory Committee on Vaccine Safety
Jean-Michel Dogné has been putting his expertise at the service of the FAMHP for many years. The Belgian expertise in vaccines is recognised worldwide with his recent appointment as a member of the Global Advisory Committee on Vaccine Safety (GACVS) of the World Health Organisation (WHO).
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.
Employees of manufacturers, importers and distributors of medical devices in the surgical area: is that allowed?
May employees of companies making, importing or distributing medical devices be present in the surgical area? Yes, but only under certain conditions.