About LMVO
LMVO is a non-profit organization representing the various partners involved in securing the legal supply chain for medicines in Luxembourg. LMVO is responsible for the implementation and management of the national medicines verification system (NMVS) in Luxembourg.
Each European country has a NMVO (National Medicines Verification Organization); for Belgium, for example, it is BeMVO. These organizations work in concert with the EMVO (European Medicines Verification Organization) which drives serialization at the european level.
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LMVO works closely with BeMVO. Indeed, the two organizations share a common National Medicines Verification System (NMVS) repository and database.
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Discover in this video what the FMD Directive is and how LMVO contributes to its implementation in Luxembourg.
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Governance
The following organizations representing the different actors involved in securing the legal medicines supply chain in Luxembourg participate in the governance of the organization:
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Mrs. Marianne Meyers, SPL , Vice-President
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Mr. Marc Gryseels, BACHI , Treasurer
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Mr. Antoon Daneels, Medaxes
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Mr. Grégory Gaudillot, APHL
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Mr. Luc Waisse, FHL
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Mr. Pieter Boudrez, BAPI
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Mr. Georges Clément, GGRLPP
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Mrs Laurence Ponchaut, Distinct Consulting , Director
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The mission of the Board of Directors is to ensure that LMVO operates in accordance with the European FMD Directive, national and international laws and the statutes of the organization.
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Serialization
Drug serialization is a system for verifying the authenticity of a drug during its distribution journey up to its actual delivery to a patient.
This system consists of placing a unique identifier on each box of medication in the form of a Datamatrix. This is a 2D matrix code with a unique and random serial number. This includes the product code (GTIN) and the expiration date. All the packaging codes are stored in a central database. This code will then be scanned at the time of dispensing by comparing it with those recorded in the central database to verify whether a medicine is genuine or whether it is a falsified medicine. Each serialized drug will also be equipped with an anti-break-in device.
Source: www.france-mvo.fr
Who does what?
LMVO
LMVO is overseeing the introduction of the European Medicines Verification System in Luxembourg in collaboration with BeMVO.
We support all parties involved in the process and are the serialization point of contact for authorities and actors in the drug distribution chain.
MAHs
The manufacturers (MAH) ensure that their products carry the security features required by the FMD: application of the unique code and of an anti-theft system, such as a seal, on the pharmaceutical packaging.
Finally, manufacturers must upload their product codes to the EMVS and keep records of the activities performed on the corresponding products.
Wholesalers
The wholesalers are connected to the database in order to be able to:
carry out tests on packaging according to a risk-based approach,
decommission products exported to countries outside the EEA,
in certain circumstances, decommission products on behalf of authorized persons.​
Pharmacists
The retail and hospital pharmacies decommission the drug when it is dispensed, thus validating that the code is mentioned in the national database and not yet decommissioned.
If the medicine is already decommissioned, it may be a counterfeit medicine. The pharmacist will not then dispense the medication to the patient.
The serialization ecosystem
Source: www.france-mvo.fr
The European Medicines Verification System (EMVS) is made up of a central HUB and of the various national verification systems (NMVS).
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Manufacturers or Marketing Authorization Holders (MAHs) and Parallel Distributors are connected to the Hub to download product information and Unique Identifiers (UIs).
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End users such as retail and hospital pharmacies decommission the medicine when it is delivered. The drug is then scanned and its authenticity verified against a national (or supranational) standard. If the UI on the pack matches the information in the repository, the pack is decommissioned and delivered to the patient. If this is not the case, an alert is issued and this packaging will not be delivered to the patient. An investigation will determine if this is a forgery.