MAH

MARKETING AUTHORISATION HOLDERS 

 MUST DO ASAP

  • Load CORRECT data for all serialized packs before they are distributed in the supply chain. 
    Correct means that all data, including the expiry date, must be 100% the same as the data in the 2D matrix code.
  • Communicate immediately the relation GTIN-CNK (national code for BE) for each product on the market in Belgium to the APB to avoid supply chain issues. Although FMD packs are carrying the GTIN, the entire supply chain is still mainly operating with the CNK. 
    Communication is done to gtin@apb.be

 REGISTRATION

 WHO 

Each Marketing Authorisation Holder, responsible for products that are in scope for FMD in Belgium and which are commercialised in Belgium, needs to register and enter into a contractual agreement with BeMVO.

 SCOPE of FMD in Belgium

This table explains the overall principle of the FMD scope for Belgium: Scope_table
For a detailed verification by product/pack we refer also to the product database managed by the Medicines Agency (FAGG/AFMPS) 
Selecting the concerned pack indicates with a flag if the concerned pack is in FMD scope or not for Belgium.

 Registration AGREEMENT

The registration agreement is composed of two documents:
The agreement : agreement operational phase
The identification form : [download form]
When completed, the documents need to be sent to: mah@bemvo.be

 PARTICIPATION FEE

The participation fee is composed of a one-time registration fee and an annual fee. The annual fee is reviewed each year and communicated to the MAHs in the fourth quarter of the preceding year.

 REGISTRATION FEE

The one-time registration fee is set to € 10.000.

 ANNUAL FEE

There are 3 annual fee categories, depending on the turnover of the MAH for the products in scope.

The base level of 3 categories are € 8 000, € 5 000 and € 2 000. However, each year, the level of the fee for each of the categories is reviewed in function of the financing needs of the BeMVO.

The current defined cut-off points for the 3 categories are:

Flat Fee level

 

Discount

2021 Fee

Standard Flat Fee

8.000,00 €

-25%

€  6 000,00

Reduced Fee

 

 

 

TO < 1mln Euro

5.000,00 €

-25%

€ 3 750,00

TO < 100.000 Euro

2.000,00 €

-25%

€ 1 500,00

Turnover is defined as:

The total sales value realized in Year-2 for the products belonging to the MAH and that are in FMD scope in the year on which the annual fee is applicable.
Example: the annual fee category for 2021 is decided based on the FMD products belonging to the MAH in January 2021 and on the turnover for these products in 2019 (even if these products did not belong to the MAH at that time).

Important:

  • The MAH must take the initiative and request to be eligible for a reduced annual flat fee
  • The MAH must bring sufficient proof of the lower turnover for the products in scope.
  • Such proof can consist of the following elements (not exhaustive list): official financial accounts, reports from a company auditor, external market measurement data, … 
    The documentation needs in each case to include the list of Medicinal Products that have been considered in this regard.
  • The request for a reduced fee must be provided to BeMVO latest by January 10th.
  • BeMVO can request at any moment additional information.
  • BeMVO reserves the right to reject the request at its own discretion, independent of the elements and information that has been provided by the MAH.

LUXEMBOURG

Although Belgium and Luxembourg share the same National Medicines Verification System (NMVS) managed by BeMVO, the governance for Luxembourg is managed by the LMVO (Luxembourg Medicines Verification Organisation).

The registration and annual fee covers only the part for Belgium. In case the MAH is also active on the market in Luxembourg (or only in Luxembourg and not Belgium), the MAH should get into an agreement with the LMVO.

For the technical side, you can find herewith the loading instructions to the Belgian NMVS for packs on the market in Luxembourg:BE-LU-data-loading-specs-LMVO-V2.1