In 2018, the following fees(*) apply to requests for national STA submitted to the FAMHP :
TYPE I :Technical-regulatory advice : € 2.217,91
TYPE II :Scientific advice : € 13.307,48
TYPE III :Mixed advice (i.e. scientific and technical-regulatory advice) :€ 17.743,32
(*) Fees for national STA are subject to indexation on a yearly basis. Indexation of the fees nomally takes place at the beginning of each calendar year.
The same fees for national STA request will apply independently of the type of applicant by whom the STA request is submitted to the FAMHP: i.e. sponsors of clinical trials, pharmaceutical/biotech companies (eg. small biotech spin offs, SME’s, global companies), research centres, etc.
The same fees for national STA request will apply regardless of the area of advice (eg. paediatrics, oncology, etc..) or timing of seeking advice at national level (eg. initial versus follow-up advice).
Payment must be made on the following bank account nr. of the FAMHP: 679-0021942-20
Contact details of the bank :
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.