The Luxembourg Medicines Verification Organisation (LMVO) has announced that Luxembourg has taken a decisive step in the fight against counterfeit medicines.
The Falsified Medicines Directive (FMD) has been fully applicable in Luxembourg and Belgium since 9 February 2024.
This Directive aims to prevent the entry of falsified medicines into the legal medicines distribution chain. This passage marks a crucial step in securing the distribution of medicines in Luxembourg.
Luxembourg and Belgium thus became the third and fourth countries to implement the European directive fully. From now on, products generating a potential falsification alert will have to be quarantined.
This step is accompanied by a European first: the management of these FMD alerts in real-time via a “National Alert Management System” (NMVS Alerts) platform to which pharmacists, manufacturers and the pharmacy and medicines division (Division de la Pharmacie et des Médicaments - DPM) of Luxembourg's Ministry of Health are connected. The serialisation governance bodies for Luxembourg and Belgium, namely the LMVO and the Belgian Medicines Verification Organisation (BeMVO), are responsible for the implementation and management of medicines' verification system in their respective countries.
The full implementation of the FMD in Luxembourg is a direct response to the growing risks posed by the circulation of counterfeit medicines. Thanks to the FMD directive, each medicine package is now equipped with a unique code, scanned and verified at each stage of its distribution, from the manufacturer to the patient, thus eradicating the possibility of falsified products entering the legal supply chain.
Buying on the Internet vs. the official distribution chain
LMVO highlighted the critical difference between medicines acquired through the official distribution channel and those purchased over the Internet. Full implementation of the FMD reinforces the security of official distribution through pharmacies, compared to the increased risks of counterfeiting and health hazards associated with unregulated online purchases, as illustrated by recent cases of falsified Ozempic pre-filled pens purchased online, leading to tragic incidents such as deaths and comas. Only the full application of the FMD Directive guarantees flawless traceability and integrity of pharmaceutical products.
LMVO therefore strongly recommended that patients continue to purchase their medicines exclusively through official distribution channels. The FMD aims to guarantee the safety, authenticity and quality of each medicine dispensed by Luxembourg pharmacies, thus eliminating the risks posed by counterfeit products.
This achievement is the result of a close collaboration between regulatory authorities, the pharmaceutical industry and supply chain partners, LMVO noted.
