Registration for Marketing Authorisation Holders (MAH)

All MAH companies distributing products that are in the scope defined by the authorities in Belgium on February 9th 2019 are subject to the FMD legislation must register to and contract with the Belgian Medicines Verification Organisation and contribute in the overall costs of the system via the one-off registration fee and the yearly flat fee.

The different steps to be compliant and use the Belgian Medicines Verification System are:
  1. Check if your MAH Company has products that are within the scope of FMD in Belgium. Even if only one product in your portfolio has to be FMD-compliant, a contract is necessary
  2. Download the registration form hereafter, fill in the Wave of your choice and send back to info@bemvo.be
  3. Download the registration contract hereafter. Pay attention: Fill out a separate contract for each MAH company being active in Belgium on February 9th, 2019
  4. Properly complete the contract
    1. Fill out the official identity of the MAH and contact credentials
    2. Indicate clearly the payment slot the MAH will use
    3. For your convenience we foresee three registration and payment waves
  5. Sign properly the contract by mandated person and provide us with the proof of mandate in a separate document 
  6. Send back ASAP – and ideally before registration deadline – the signed contract (1 copy)
  7. In return you will receive an invoice and an invitation to pay (in period of your choice)
Form and Contract:
Scope

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