MUST DO ASAP
- Load CORRECT data in the EU-HUB for all serialized packs before they are distributed to 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 GTIN-CNK (national code for BE) combination for each medicinal product on the Belgian market to the APB to avoid supply chain issues. Although FMD packs are carrying the GTIN, the entire Belgian supply chain is still mainly operating with the CNK.
Communication must be sent to gtin@apb.be
RECALL INSTRUCTIONS
The delegated regulation states that a batch subject to a recall, or subject to withdrawal, should be decommissioned in the EMVS system for the affected markets. Usage of recall and withdrawal functionalities in the EMVS can further improve security in the medicine distribution by preventing that recalled or withdrawn packs are dispensed to patients.
REGISTRATION
WHO?
Each Marketing Authorisation Holder, responsible for medicinal products within the Belgian scope of FMD and commercialized in Belgium, must register and sign a contractual agreement with BeMVO.
FMD SCOPE 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 Federal Medicines Agency (FAGG/AFMPS / FAMHP).
Selecting the concerned pack, a flag indicates if the concerned pack is within the FMD scope or not for Belgium.
FEES
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 within the scope.
Standard fee, Medium fee, Low fee.
However, each year, the level of the fee for each of the categories is reviewed in function of the financing needs of the BeMVO.
Turnover is defined as:
The total sales value realized in Year-2 for the products belonging to the MAH and that are within the FMD scope in the year in which the annual fee is applicable.
Example: the annual fee category for 2024 is determined on the FMD products belonging to the MAH in January 2024 and on the turnover for these products in 2022 (even if these products did not belong to the MAH at that time).
IMPORTANT
- To benefit from 25% of the reduced fees, we must receive the application form fully completed before 10th January. Later applications will be charged the standard flat fee (€ 8 000), regardless the turnover.
- The MAH must take the initiative and request to be eligible for a reduced annual flat fee and therefore submit the application form. The MAH must sufficiently prove the lower turnover for the products within scope.
Such proof can be for example: official financial accounts, reports from a company auditor, external market measurement data, … - The documentation must always include the list of Medicinal Products that have been considered in this regard.
- 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 provided by the MAH.
LUXEMBOURG (LMVO)
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 have an agreement with the LMVO.
Hereunder you can find the loading instructions to the Belgian NMVS for packs on the market in Luxembourg: