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 email@example.com
Form and Contract:
MAH AGREEMENT for the OPERATIONAL PHASE
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