Procedures for the introduction and the follow-up of a scientific-technical advice application

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 on CD-rom or USB key.

In addition, applicants are asked to send at least two hard copies of the national STA request by post to the following address:

Federal Agency for Medicines and Health Products
Directorate-General PRE-authorisation (desk 8D222)
Victor Hortaplein 40/40
B-1060 Brussels
BELGIUM

To the attention of Ms. Greet Musch

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 (access format) mentioned below and should (1) include the completed electronic document in the STA request that will be submitted electronically and (2) include a paper copy in the STA dossiers that should be sent by post to the FAMHP.
« Electronic application form»

Important remark for completing the application form :
Temporarily, Type I STA requests can still be indicated in the electronic application form as “Ad Hoc” STA requests whereas Type II and Type III STA requests can be indicated in the electronic application form as “Full” STA requests. The electronic application form will be adapted soon in function of the new definitions for national STA requests which entered into force on October 18th 2012.

2. Fee payment

Each submitted STA request must be accompanied by payment of the appropriate fee:

  • Each type I STA request requires payment of € 1037,42
  • Each type II STA request requires payment of € 6224,55
  • Each type III STA request requires payment of € 8299,41

The fees are applicable to both initial or follow-up STA requests.

Payment must be made on the following bank account nr. of the FAMHP: 679-0021942-20.

Contact details of the bank :

Poste financière
Chaussée d'Anvers 59
B-1100, Bruxelles (Belgium)
IBAN : BE28 6790 0219 4220
BIC : PCHQBEBB

Applicants should clearly mention on the bank statement the type of STA request that is being submitted to the FAMHP and if the STA request concerns an initial or follow-up STA request; followed by the name of the applicant. The topic of the STA request (eg. product name) should also be clearly mentioned.

For each initial or follow-up STA requests a separate payment should be made.

For payments from abroad the transfer fees should be paid by the payer. Applicants are also requested to include a proof of payment (eg. a bank statement) to the STA request since this is verified during the validation of the STA request.

In case that an inappropriate fee was paid by the applicant which does not correspond to the correct fee (eg. when submitting the STA request under the wrong procedure), the applicant will be contacted during validation of the STA request in order to make the appropriate payment.

In case the applicant should ask for a withdrawal of his STA request after payment of the fee (as part of the formal submission to the FAMHP), the fee will not be refunded by the FAMHP.

When a formally submitted STA request is declared invalid by the FAMHP at the end of the validation phase of the procedure, the fee will be refunded to 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)». 

Last updated on 10/07/2017