1. Submission
Any official request for a national scientific-technical advice (STA) relating to the qualification/classification of a borderline product must be submitted to the FAMHP's Directorate-General PRE Authorisation. Requests should be sent electronically to sta@fagg-afmps.be.
If necessary, for example when large electronic files (≥ 10 MB) need to be submitted, electronic STA requests can also be submitted via EudraLink or sent on a USB stick to:
Federal Agency for Medicines and Health Products (FAMHP)
Directorate-General PRE authorisation
National Innovation Office and Scientific-Technical Advice Unit
Avenue Galilée 5/03
1210 BRUSSELS
Belgium
Each STA request must be sufficiently supported by appropriate documentation and a duly completed application form to ensure efficient processing of advice requests throughout the procedure and to enable the FAMHP to formulate accurate, high-quality advice.
Detailed information on the documentation required to support an advice request can be found in the guidance document (see Regulations).
Applicants are asked to fill this application form and include it with the STA application.
2. Payment of fees
Please find all the information you need on applicable rates below
• STA fees
• Guidance document (see Regulations)
Rates apply to both initial and follow-up STA requests.
3. Procedure
All STA requests relating to the status and classification of a borderline product are subject to a validation stage to check that the request complies with all the requirements set out in guidance document (see Regulations).
If considered necessary, the FAMHP can request additional information from the applicant during the STA procedure. If this is the case, the deadlines are suspended until the requested information has been obtained.
Following formal validation, STA requests are processed by the FAMHP in writing and the final advice will by default be communicated to the applicant within ninety calendar days in accordance with Article 4, 3° of the Royal Decree on scientific and technical advices relating to health products and advices relating to the status and classification of a product.
More detailed information, including the legal scope of the request, procedures and deadlines, can be found in the guidance document (see Regulations).
Once the final advice has been issued, the applicant will receive a feedback questionnaire which can be completed and returned to the FAMHP on a voluntary basis.
The aim of the questionnaire is to gather feedback from applicants on the qualitative aspects of the services provided by the National Innovation Office and Scientific Technical Advice unit.