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. More information on the process can be found in the Registration section.

Registration


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.

Serialisation codes for Luxembourg

Guideline for Country Specific product master:
In all cases the country code is BE, but depending on (1) where the product is distributed, (2) which country was used for registration of the product, (3) if the product is also in scope and on the market in Belgium, (4) the Product Code used to identify the product, another national number must be added. So:
  • A product only distributed in LU must be uploaded with country code BE followed by Luxembourg national number
  • A product distributed in LU & BE must not be uploaded for LU since this product has already been uploaded for BE – however if not yet uploaded for BE (eg not in scope for BE) then it must be uploaded with country code BE followed by CNK
  • A product distributed in LU & FR must be uploaded with country code BE followed by CIP13 code – however, if a record for that Product Code was already uploaded for BE, then it should not be uploaded for LU
  • A product distributed in LU & DE must be uploaded with country code BE followed by PZN code – however, if a record for that Product Code was already uploaded for BE, then it should not be uploaded for LU
  • A product distributed in LU & FR & DE must be uploaded with country code BE followed by either CIP13 or PZN codes – however, if a record for that Product Code was already uploaded for BE, then it should not be uploaded for LU
  • A product distributed in LU & another country (not being BE, DE & FR) must be uploaded with country code BE followed by Luxembourg national number – however, if a record for that Product Code was already uploaded for BE, then it should not be uploaded for LU
  • Multi-Market-Packs (without BE among destination countries): Product must be uploaded with country code BE followed by code of country of origin (as registered with Luxembourg MoH), i.e. CIP13 for FR, PZN for DE, Luxembourg national number for any other country
  • Multi-Market Packs (with BE among destination countries): Product must always be uploaded with country code BE followed by CNK (notwithstanding country of origin) if the product is not yet uploaded for BE (eg not in scope)

 A short explanation on serialisation codes:
For more detailed information, please refer to our specific guide:

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

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.

Go to the Registration