1. Submission
Each official application for national STA that falls within the legal definition of a Type I, II or III STA application must be submitted to the FAMHP’s Directorate General PRE authorisation. These applications should be sent electronically to sta-wta@fagg-afmps.be.
When necessary, for example when large electronic files (≥ 5 MB) need to be submitted, electronic STA applications may also be submitted via EudraLink or via an online data sharing platform of your choice.
Each STA application must contain sufficient supporting documentation and a completed electronic application form to ensure efficient processing of the requests for advice during the procedure and to enable the FAMHP to formulate targeted and high-quality advice.
You can find detailed information about the supporting documentation to be included in a STA application in National Scientific-Technical Advice (STA): dossier content and format – Guidance for applicants.
Applicants can use the Electronic application form (Word). The completed electronic document must be sent together with the STA application.
If you encounter problems with the form, you can always contact us via sta-wta@fagg-afmps.be or at the following address:
Federal Agency for Medicines and Health Products
Directorate-General PRE authorisation
National Innovation Office and Scientific-Technical Advice Unit
Galileelaan - Avenue Galilee 5/03
1210 BRUSSELS
BELGIUM
2. Payment of the fee
All information on the applicable fees:
• STA contributions 2025
• Detailed guidance for National Scientific-Technical Advice (STA) requests (page 13).
The fees apply to both initial and follow-up STA requests.
3. Procedure
All submitted STA applications are subjected to a validation step in order to verify whether the application complies with all the file requirements described in paragraph 1.
• Type I STA applications are processed by the FAMHP in writing, within thirty calendar days after validation.
• Type II and Type III STA applications are treated by the FAMHP in a face-to-face consultation meeting or teleconference meeting with the applicant within seventy calendar days after validation.
Exceptionally, Type II and III STA applications may be treated in writing at the special request of the applicant and only when justified.
Applicants are requested to prepare the minutes of the meeting and return them to the FAMHP within five working days following the meeting. The minutes are an informal written record of the topics discussed during the advisory meeting and are not corrected or commented on by the FAMHP. The FAMHP then sends the final advice to the applicant by email no later than twenty-one calendar days after the advisory meeting.
More detailed information, including the definition of a Type I, II or III STA application, legal scope, procedures and timelines, can be found in the Detailed guidance for National Scientific-Technical Advice (STA) requests.
After the final advice has been issued, the applicant will receive a request for feedback (FAMHP questionnaire on National Scientific Technical Advice (STA)) which can be completed and returned to the FAMHP on a voluntary basis.
The aim of the questionnaire is to obtain the applicant's opinion on the quality aspects of the national STA services received.