News FAMHP

As Belgium acts as a logistics platform for certain medicinal products, the ban on exports outside the EEA (European Economic Area) could result in other countries being needlessly prevented access to medicines. The export ban will be replaced by a notification requirement to the FAMHP. The FAMHP can still ban exports in the interest of Belgian patients.

The FAMHP has once again put in place a number of measures to avoid shortages of drugs during the coronavirus pandemic (COVID-19).

The FAMHP is monitoring the availability in Belgium of medication, including medication indispensable for treating COVID-19 inpatients, on a daily basis. In this context, the FAMHP is taking a number of measures to avoid medication shortages.

Certain stocks of over-the-counter medicinal products have been selling out rapidly in Belgian pharmacies recently as many citizens are stocking up on medicinal products. There are still sufficient wholesale stocks of medicinal products in Belgium, but to avoid a shortage, the FAMHP asks all citizens not to pointlessly stock up on medicinal products.

The FAMHP is closely monitoring stocks of medicinal products used in the fight against COVID-19. Certain of these medicinal products are essential to treat patients with chronic diseases (e.g. lupus, rhumatoid arthritis, HIV, etc.). The FAMHP is taking measures to guarantee the availability of these essential medicines.

A new law provides for additional measures to limit the unavailability of medicines. The main guidelines of the new law are a clarification of the supply obligation of pharmaceutical companies, the possibility to prohibit or restrict the export of unavailable medicines and the possibility for pharmacists to supply an alternative medicine under certain conditions.

Clamoxyl I.V.-I.M. is available again. The recommendations formulated by the FAMHP and the NIHDI for rational use by hospital pharmacists and physicians-specialists no longer apply. The marketing of Clamoxyl I.V.-I.M. and of Augmentin I.V. will eventually be definitively discontinued.

A new reporting system will be available on December 5, 2019. To avoid errors, reports may only be made through the current system until December 2, 2019.

Via the new online application PharmaStatus, marketing authorization holders can notify the FAMHP of unavailability and start or stop of commercialization of a drug. Marketing authorization holders are invited to an information session on November 18, 2019.

Through possible limited availability of intravenous immunoglobulins, there is a threat of a shortage in some hospitals in Belgium. The Federal Agency for Medicines and Health Products (FAMHP) is giving recommendations for hospital pharmacists and physician-specialists within the hospitals.