Proper Use of Medicine Division


Proper Use Division

General e-mail address

Questions on the proper use of medicines:
Proper use of medical devices:
FAMHP medicinal products database:
Availability of medicines: 
Advertising medicinal products: 
Risk Minimisation Activities (RMA): 
Sunset clause: 

General phone number

+32 2 528 40 00

Key tasks

  • Offer clear and understandable information to patients on the proper use of medicines, medical devices and their accessories.
  • Improve the availability, to patients in Belgium, of antimicrobials and to promote their correct and rational use.
  • Contribute towards the National Action Plan (NAP) against microbial resistance.
  • Update and publish information on human and veterinary medicines in the medicinal products database. This database contains links to relevant documents such as the patient information leaflet, the summary of product characteristics (SPC), the Risk Minimisation Activities (RMA) and the Direct Healthcare Professional Communication (DHPC).
  • Daily monitoring of temporarily unavailability or discontinuation of medicines. Based on a decision tree, the public health impact resulting from the unavailability of a medicinal product or from its removal from the market are assessed and appropriate measures are taken to minimise impact on patients as much as possible. 
  • Preliminary check of all notifications and applications for the approval of advertising to the general public involving medicinal products for human use available "without prescription" and all information campaigns on radio or television that directly or indirectly refer to a medicinal product or group of medicinal products. The division is also involved in developing standards applicable to the advertising of medicinal products.
  • Review and approval of risk minimisation activities (RMAs) as a condition for the marketing of a medicinal product.
  • Application of suspensions of marketing authorisation (MA) or registration in accordance with the Sunset Clause. This means that an MA or registration of a medicinal product that is not or no longer actually on the market for three consecutive years will expire under the terms of the Medicines Act of 25 March 1964.
Last updated on 30/11/2023