The status of certain products is not always clear.
They belong to a “grey area”: products lying somewhere between medicinal products, food supplements, cosmetics, biocides, nutrients or daily consumer goods.
Two procedures can be initiated to clarify the status of a product, depending on its stage of development:
The national scientific-technical advice (STA) procedure
This procedure focuses primarily on products that are in pre-clinical or clinical development with a view to future marketing in Belgium or Europe. This type of opinion procedure is coordinated by the FAMHP's STA unit, and the formal opinion issued by the FAMHP is not legally binding, either on the applicant or on the FAMHP. This procedure for requesting an opinion is not free of charge for the applicant (e.g. companies, academic organisations, hospitals, SMEs, etc.).
The Commission for borderline products procedure
This procedure, which is coordinated by the FAMHP's Commission for borderline products, can be used by the applicant for products that are already on the Belgian market or the European market and whose development has already been fully finalized. The opinion issued by the FAMHP via the Commission for borderline products is formulated on behalf of the Minister of Public Health in a formal opinion that is legally binding on the applicant and the FAMHP.
The applicant can be a (non)commercial entity as well as a competent authority.
More information
Commission for borderline products procedure
National scientific-technical advice (STA) procedure