1. Submission
Any official application for a national STA that satisfies the legal definition of a type I, II or III STA application, must be submitted to the FAMHP's directorate general (DG) PRE authorisation. These applications should be sent electronically to sta.meddev@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 be sufficiently supported by appropriate documentation and a duly completed application form to ensure efficient processing of the requests for advice during the procedure and to enable the FAMHP to formulate targeted, high-quality advice.
Detailed information about the supporting documentation to be included in an STA application can be found in the guidance document (see Regulations).
Applicants are asked to fill this application form and include it with the STA application.
If you encounter problems with the form, you can always contact us via sta.meddev@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
Please find all the information you need on applicable rates below:
• STA fees 2025
• Guidance document (see Regulations)
The fees apply to both initial and follow-up STA requests.
3. Procedure
All STA applications are subject to a validation stage to check that the application complies with all the requirements set out in the guidance document (see Regulations).
• Type I STA applications are processed by the FAMHP in writing, within 30 calendar days after validation. They address requests for advice on one specific question.
• Type II and Type III STA applications are processed by the FAMHP during an in-person or remote consultation meeting with the applicant within 70 calendar days after validation.
They address requests for advice on a set of multiple, specific questions (Type II for one domain of expertise, Type III for multiple domains of expertise).
Exceptionally, Type II and Type III STA applications may be processed in writing at the special request of the applicant and only where this is justified.
Applicants are asked to prepare the minutes of the meeting and return them to the FAMHP within five working days of the meeting. The minutes are an informal written record of the topics discussed in the consultation meeting and the FAMHP does not formally correct or comment on them. The FAMHP then sends the final advice to the applicant by email no later than 21 calendar days after the consultation meeting.
More detailed information, including the definition of a Type I, II or II STA application, the legal scope of the application, 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.