Every Marketing Authorization Holder (MAH) that distributes medicinal products that fall within the Belgian scope of the Falsified Medicines Directive (FMD) by February 9th 2019 must register to and contract with the Belgian Medicines Verification Organisation (BeMVO). In addition, they must contribute in the overall costs of the system via the one-off registration fee and the yearly flat fee.
The scope of the FMD legislation is defined by the Belgian authorities as follows:
– All products that are subject to a 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 if listed on the white list.
More details can be found in the scope decision table.
The different steps to be compliant and more information on how to use the Belgian Medicines Verification System can be found here.