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.

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.

After successful consideration among the FAMHP, the National Institute for Health and Disability Insurance (RIZIV-INAMI) and the manufacturer Therabel, the manufacturer has decided to continue to produce the drug Marevan. The FAMHP calls on pharmacists and patients to not order unnecessary inventories of the drug so that the drug will remain available for all patients.

The company Kela Pharma has indicated that, due to production issues, its Maniprex® 250 mg coated tablets and Maniprex® 500 mg film-coated tablets will be unavailable for an indefinite period once current stocks have been exhausted. The stock of Maniprex® 500 mg has already been exhausted, and Kela Pharma predicts, based on normal circumstances, that the stock of Maniprex® 250 mg will be exhausted by June 2018.