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During its meeting of 10 – 13 February 2020, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommends restrictions in use of cyproterone due to meningioma risk.

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.

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).

Despite the annual awareness campaigns conducted by the Federal Public Service Health, Food Chain Safety and Environment, the consumption of sleeping pills and sedatives at Belgian level remains a cause for concern. In order to collect concrete information on the use of some of these drugs in Belgium, the FAMHP will conduct a national online survey in February 2020.

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.

The EU-Innovation Network announces a pilot project for simultaneous national scientific advice (SNSA) to strengthen early regulatory support for innovation. The pilot project kicks off with developing a best practice model starting 1 February 2020.

The FAMHP has created an online form for healthcare professionals to notify any adverse effects of medicinal products for human use. This new format incorporates the patient notification form for that has been online since March 2019. From now on, anybody can notify adverse effects of medicinal products using simplified online forms available at a single address: or

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.

May employees of companies making, importing or distributing medical devices be present in the surgical area? Yes, but only under certain conditions.

L’Amérique du Nord connait depuis plusieurs années une « épidémie » d’abus, de surdosages et de décès liés aux opioïdes. Dans une moindre mesure, ces dernières années l’utilisation d’opioïdes en Europe a fortement augmenté, entre autres pour faire face au syndrome de la douleur chronique. Bien que s’inscrivant dans le cadre de l’amélioration de la prise en charge de la douleur, l’utilisation accrue d’opioïdes est remise en question au vu des risques associés à leur abus. L’accent est donc mis sur la prévention de la dépendance et des abus, et sur l’importance de l’usage rationnel des opioïdes.