The fees vary depending on whether it is the first consultation request (new product) or a reconsultation request (variation) when the manufacturer of the medical device wishes to submit any changes to the active substance or the tissues or cells of human origin or their derivatives incorporated into the medical device.
Manufacturers do not pay a fee when submitting a consultation request but receive an invoice which is sent by the FAMHP Budget and Management Control Division after the request has been formally validated.
In order to draft the invoice, the NB is requested to provide the invoicing details of the manufacturer at the time of the submission of the initial request (this can be in the Letter of Intent to Submit, LIS).
With each payment, the structured communication on the invoice must be mentioned, allowing us to link the payment with the correct invoice, even if a third party makes the payment. Without structured communication the invoice will be considered as unpaid.
About the procedure
- Each quarter the company receives an invoice for all procedures that were submitted in the past quarter.
- Each invoice mentions the references of the files.
- The fact that the FAMHP does not use Purchase Order (PO) numbers is not a valid reason not to pay an invoice.
- You always receive the invoice at the invoice address. Please include your email address for invoicing purposes in the covering letter when submitting the advice request.
- Have you made a wrong payment? Send an email to refund@fagg-afmps.be to request a refund.
- Any bank fees for payments from abroad cannot be charged to the FAMHP. These fees are to be borne by the payer.
- If the applicant withdraws their consultation request after its validation, the fee must still be paid.
- If the FAMHP declares a formally submitted consultation request invalid at the end of the validation phase of the procedure, no fee will be payable by the applicant.