Important

February 9, 2019

Delivery of products for MAH’s that have not registered to the national system will not be possible after February 9, 2019. For more info, see the Luxembourg national legislation on FMD.

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
 
Annual fees for 2021 :
Flat Fee LevelFee2021 Discount
Standard Flat Fee2.500,00 EUR-10%
Reduced Fee:
TO * < 200.000 EUR1.200,00 EUR-10%
TO* < 20.000 EUR500,00 EUR-10%
TO* = 0 EURZERO

The reduced Flat Fee can be approved by LMVO 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. 2019 for the 2021 Flat Fee).
  • The MAH must bring sufficient proof of the lower turnover for the products in scope.
  • LMVO can request at any moment additional information.
  • LMVO reserves the right to reject the request at his own discretion.
  • The request for a reduced lowered Flat Fee must be sent to INFO@LMVO.LU by 15th December 2020 at the latest.

Serialisation codes for Luxembourg 

As explained, the basic loading principle 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.

 A short explanation on serialisation codes:

Screen Shot 2018-01-05 at 12.04.06

For more detailed information, please refer to our specific guide: BE-LU data loading specs LMVO V2.1

For more detailed questions (and answers) please also refer to Commission’s “Q&As“, latest version (V9 of 13.02.2018).

2 Critical Steps

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:
Explanatory video : https://emvo-medicines.eu/home/obp/

  1. Register to the Luxembourg Verification System: contact LMVO: info@lmvo.lu 

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 production 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:

Indian legislation

The form to be used to request derogation (to be allowed to export packs to the EU without serialized codes) can be found here.