A national scientific-technical advice (STA) relating to the qualification of a borderline product within the FAMHP can be requested for the various product categories that fall within the FAMHP's areas of competence (see Article 2, §1, 2°/2 and 8° of the Act of 20 July 2006 on the establishment and operation of the Federal Agency for Medicines and Health Products). In the event that the FAMHP is of the opinion that the product for which a qualification advice is formally requested falls outside its areas of competence, the request will be automatically transferred to the authority in Belgium deemed to be competent for this type of product (e.g. FPS Public Health, Food Chain Safety and Environment).
Furthermore, for medical devices and IVD products an advice on the classification can be requested through the Borderline STA procedure (cfr. Article 2, 13° of the Royal Decree of 12 May 2024 on implementing scientific and technical advice on health products and advice on the status and classification of a product).
An STA can be requested at any stage. However, the national STA procedure focuses mainly on products in (pre)clinical development. As part of this STA procedure, the National Innovation Office and Scientific-Technical Advice unit can consult experts who are represented on various FAMHP commissions.
However, for products that are already on the market or whose development has been finalised, the FAMHP's Commission for Borderline Products can be consulted for advice on the product's status. The advice of the Commission for Borderline Products is legally binding. Further information is available on our website. You can also contact the secretariat of the Commission for Borderline Products at borderline.hum@fagg-afmps.be.