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 :

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

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

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

d) Turnover = 0 EUR for FMD in-scope products in Luxembourg = 0 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.

Packs from India

Given the go live of FMD on 9 february we try to mitigate to a maximum effort alerts. This is an industry responsibility One open item on the issue list are Indian packs (country of prodution India ) where a similar 2D serialization (including Gtin product coding and serialization) is required for ALL medicines, even if they are only intended for the EU market. This means that e.g. OTC-products can lead to false alerts in our BeMVS system, because most OTC packs are not allowed to have a serial number according FMD regulation. Such packs will not be allowed on the market if released after 9 FEB 2019.
For packs that are in scope for FMD in Belgium (and EU), Companies should also check whether the serialization meets the European standards and codes are loaded properly in the EUhub.

For this reason a solution is provided. In India a specific government instance is competent to grant exemptions for export.

Extract from Indian legislation:

This is the form to be used to request derogation (to be allowed to export packs to the EU without serialized codes):

https://pharmexcil.com/circulars/applications-invited—exemption-from-barcoding-under-rule–v–of-public-notice-no.-52-2015-2020-dt:-05.01.2016/9846/d51088cdf50ec85c0154c070dc76d7e2.html