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

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@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 sent by CD-ROM or USB to:

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 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 (Microsoft Access). The completed electronic document must be sent together with the STA application.

If the applicant does not have Microsoft Access software, a Word version of the electronic application form can be requested at sta@fagg-afmps.be.

 

2. Payment of the fee

For each STA application an appropriate fee needs to be paid.
All information on the applicable fees:

STA contributions
Detailed guidance for National Scientific-Technical Advice (STA) requests (page 17).

The fees apply to both initial and 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 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 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.

 

Last updated on 11/03/2022