Registration for Marketing Authorisation Holders (MAH)

The registration fee for each MAH that has products in scope for Belgium is 20 000 Euro by MAH.
The registration form has to be completed and sent to

Form and Contract:

MAHs having already registered will be requested to sign the new Agreement that will replace the existing Agreement.
MAH contract new v.0.6 – feb 2019


The Belgian scope of FMD is defined as follows:

 – All products under prescription according to the Belgian legislation

– Plus the black list products as identified in annex 2 of the FMD

– Minus the white list products as identified in annex 1 of the FMD

– Plus all reimbursed products bearing a RIZIV/INAMI reimbursement serial barcode today; except those products on the white list.

For your convenience, hereby the scope decision table (.pdf) : Scope matrix v 4.0 20APR2017-1