1. Submission
Any official request for national STA falling within the legal scope of a Type I, II or III STA request should be submitted to the Directorate-General PRE-authorisation of the FAMHP. These requests should be sent electronically to our central mailbox: sta@fagg-afmps.be
Alternatively, eg. in case large electronic files above 5 MB would be submitted, electronic STA requests can also be sent via EudraLink or on CD-rom or USB key to 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
Each STA request must contain sufficient supportive documentation and a completed electronic application form in order to ensure an effective and efficient handling of the advice requests throughout the procedure and to allow the FAMHP to provide a pointed advice of sufficient quality. Detailed information regarding the supportive documentation to be included in a STA request can be found in annex below:
« National Scientific-Technical Advice (STA) : dossier content and format – Guidance for applicants »
Applicants can download the electronic application form (Word format) mentioned below and should include the completed electronic document in the STA request.
« Electronic application form»
2. Fee payment
All information concerning the applicable fees can be retrieved from the document below:
- Detailed guidance for National Scientific-Technical Advice (STA) requests (page 13)
The fees are applicable to both initial or follow-up STA requests.
From 1 October 2021, the FAMHP will use a new invoicing method for national STA applications of types I, II and III that are handled by the National Innovation Office and Scientific-Technical Advice Unit.
This means that applicants will no longer pay a fee when submitting the application for advice, but will have to pay the invoice sent by the FAMHP’s Budget and Management Control Division. Each payment should be accompanied by the structured reference on the invoice, so that the payment can be linked to the correct invoice, even if the payment is made by a third party. Without the structured reference, we will consider the invoice as unpaid.
About the procedure
1. The company receives a quarterly invoice for all national STA applications submitted during the previous quarter.
2. The invoice lists the references of the files.
3. The fact that the FAMHP does not work with Purchase Order (PO) numbers is not a valid reason for not paying an invoice.
4. You always receive the invoice at the invoicing address. Please state your email address for invoicing purposes in the "cover letter" when submitting the request for advice.
5. Have you already paid a fee for a recent request for advice? Send an email to refund@fagg-afmps.be(link sends email) to request a refund of the fee.
6. Any bank charges for payments from abroad cannot be charged to the FAMHP. These costs will be covered by the payer.
7. If the applicant withdraws a STA application after validation of the application, the fee will still have to be paid.
8. If a formally submitted STA application is declared invalid by the FAMHP at the end of the validation phase of the procedure, no fee will have to be paid by the applicant.
3. Procedure
All submitted STA requests are subjected to a validation step in order to verify compliance with the dossier requirements outlined in paragraph 1.
Type I STA requests will be addressed by the FAMHP in writing, within 30 calendar days after validation.
Type II and Type III STA requests will be addressed by the FAMHP in a face-to-face scientific advice meeting or through a teleconference meeting with the applicant within 70 calendar days after validation. On exceptional basis Type II, III STA requests can be addressed in writing on special request of the applicant if justified. Applicants are requested to draft up the meeting minutes and send them back to the FAMHP within 5 working days after the meeting. These meeting minutes won’t be corrected or commented by the agency and they consist of a summary of the topics that have been discussed during the meeting. The final scientific advice will be sent to the applicant per e-mail within 21 calendar days after the scientific advice meeting.
Further detailed information regarding the definition of a Type I, II or III STA request, legal scope, procedures, timelines, etc. can be found in annex below:
«Detailed guidance for National Scientific-Technical Advice (STA) requests»
After the final STA advice has been given, the applicant will receive a feedback questionnaire which can be filled in on a voluntary basis and which can be sent back to the FAMHP.
The questionnaire is intended to obtain the applicant’s opinion on the quality aspects of the received national STA service:
«FAMHP questionnaire on national scientific technical advice (STA)».