Stakeholders – Marketing Authorisation Holders (MAH)

Marketing Authorisation Holders

MUST DO ASAP

  • Load CORRECT data for all serialised packs that are already on the market in Belgium/Luxembourg into the FMD repository through the EU Hub connection.
    Correct means that all data, including the expiry date, must be 100% the same as the data in the 2D matrix code.
    See EU Commission Q&A Version 13 question 8.9.
  • Communicate immediately the relation GTIN-CNK (national code for BE) for each product on the market in Belgium to APB to avoid supply chain issues.
    Communication is done to 
    gtin@apb.be

REGISTRATION

The registration fee for each MAH that has products in scope for Belgium is 20 000 Euro by MAH.

ANNUAL FEE

The annual fee for 2019 has been set to 8 000 Euro.
Companies with a lower turnover for the Medicinal Products in scope for Belgium can apply for a reduced annual fee.

The reduced annual fee can be approved by BeMVO under following conditions:

  • The MAH must take the initiative and request to be eligible for a reduced annual flat fee
  • The reference year is Y-2 (ex. 2017 for the 2019 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.
  • 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.

The current defined thresholds for a reduced flat fee and the estimated annual amounts are as follows:

Current defined category                      Annual Flat Fee
MAH Turnover < € 1 000 000                   € 5 000 (without VAT)
MAH Turnover < € 100 000                      € 2 000 (without VAT)

BeMVO has the right to define new turnover categories for a reduced flat fee each year.
For more information see the Registration section.
The registration section contains also the NEW AGREEMENT for the OPERATIONAL Phase, replacing the current agreement.

REGISTRATION FORM
 

The registration form has to be completed and sent to info@bemvo.be.
See Registration section for the Registration Form.

MAH AGREEMENT for the OPERATIONAL PHASE

MAHs having already registered will be requested to sign the new Agreement that will replace the existing Agreement.
You will receive more information on this soon.

Important:

MAH’s must communicate as soon as possible the GTin and corresponding CNK to gtin@apb.be to be included in the conversion table. GTins missing in the conversion table might be rejected by end users when performing verifications.
The quality of the print of the 2D-Matrix on the packs is critical to ensure a smooth delivery of the medicines in the supply chain.
The MAH can ask GS1 to verify the quality of the print(s).

MAH’s  take an important responsibility in the deployment of the Falsified Medicines Directive.

They need to:

  • Make sure the packaging is compliant with the requirements on the safety features
  • Bring the new packages to market in a transition period
  • Keep record of applied safety features 
  • Engage with all stakeholders in the distribution chain
  • Set up an organization to implement the system
  • Organise support for the different stakeholders
  • Finance the central and national databases
  • Ensure high quality levels and state of the art security procedures
  • Align with National Competent authorities on country specific requirements
  • Adapt the production line and keep record of the generated Unique Identifiers
  • Connect to the EU Hub and have a smooth process for loading the data (product and codes)
  • Register to the National Verification system to allow verification by end-users in the respective countries.

 Extended information and ToDo’s lists can be found in following documents:

MAH_Bemvo_web-en

MAH_Bemvo_web2-en

It is critical for the MAH to have the Product information and Unique Identifiers loaded to the National systems. Non-compliance will result in Pharmacies and Hospitals not being able to deliver the products to the patients.

Two important steps to start now are:

  1. Register and connect to EU Hub

Extended information on the procedure can be found on the EMVO site:
Onboarding : https://emvo-medicines.eu/pharmaceutical-companies/

  1. Register to the Belgian Verification System

Delivery of products for MAH’s that have not registered to the national system will not be possible after February 9, 2019. More information on the process can be found in the Registration section