Marketing Authorisation (stake)Holders (MAH)

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.

Fees

Adhesion fee :

4’000 EUR for all MAH registered after 1 August 2018 (for MAH registered until 31 July 2018, adhesion fee = 4’200 EUR)

Annual fees for 2019 :

Turnover above 200’000 EUR for FMD in-scope products in Luxembourg = 2’500 EUR

Turnover above 20’000 EUR and equal or below 200’000 EUR for FMD in-scope products in Luxembourg = 1’200 EUR

Turnover equal or below 20’000 EUR for FMD in-scope products in Luxembourg = 500 EUR

Turnover considered for year x = x-2 (for 2019 = turnover 2017)

In order to benefit from reduced fees, MAH needs to submit original (no copy, no e-mail) testimony of external auditors of turnover below thresholds. External auditor needs to be registered in country of origin.

Serialisation codes for Luxembourg

As explained, the basic loading principle for is that both for Belgium and Luxembourg the Product Master data (and more specific the Product per Market data) are loaded with Member state ISO code BE and that the same Product Code is not loaded twice.

In summary, this means:

A product that is (1) officially registered, (2) in FMD scope and (3) active on the market in Belgium AND/OR Luxembourg, needs to be loaded with Member state ISO ID “BE”, where the same Product Code cannot be loaded twice.