Drug Serialization Frequently Asked Questions
Answers to the most frequent questions about drug serialization and the PharmaliZr software.
Serialization means placing a unique identifier on each medicine pack, encoded in a DataMatrix code (serial number, product code, batch number and expiry date), together with an anti-tampering device. Before dispensing, this code is scanned and verified against a national repository to guarantee the medicine's authenticity and fight falsified medicines.
The obligation applies to everyone dispensing prescription medicines: community pharmacies, hospital and clinic pharmacies (PUIs) and hospital groups. Manufacturers and marketing-authorization holders apply the unique identifier upstream; dispensers verify and decommission it at the point of dispensing.
Serialization stems from the EU Falsified Medicines Directive 2011/62/EU and its Delegated Regulation (EU) 2016/161, in force since 9 February 2019. In France the system is operated by France MVO through the national verification system (NMVS), connected to the European hub.
The NMVS (National Medicines Verification System) is the national repository where the unique identifiers of packs are verified and decommissioned. In France it is run by the France MVO (Medicines Verification Organisation), which connects national stakeholders to the European EMVS system.
The pharmacist scans the pack's DataMatrix code with a 2D scanner. The software queries the NMVS to confirm the unique identifier exists and is active, checks the anti-tampering device, then decommissions the identifier at dispensing. If something is wrong, an alert is raised.
All you need is an internet-connected workstation and a scanner able to read 2D DataMatrix codes, such as the Zebra DS2278-SR. No heavy equipment is required: PharmaliZr runs directly in the browser.
Yes. PharmaliZr is a standalone solution that deploys without changing your pharmacy management software (LGO) or hospital information system (HIS). You keep your existing tools and add serialization verification on top.
PharmaliZr is offered as a monthly SaaS subscription with no time commitment, starting at €50 per month. On-Premise and API plans are also available depending on your needs. Details are on the Pricing page.
Deployment is fast: a pharmacy or facility can be operational within 48 hours, with no heavy installation since the solution is accessible online.
Yes. PharmaliZr serves community pharmacies as well as hospital pharmacies (PUIs), clinics and hospital groups. The solution is available through key public procurement frameworks (UGAP, ELODI) to make acquisition easier for healthcare facilities.
An alert means a pack could not be verified normally: unknown identifier, already decommissioned, recalled batch or tampered anti-tampering device. The pack must be quarantined and not dispensed until the issue is resolved. PharmaliZr guides you step by step through interpreting and handling each alert.
Quarantining means isolating a suspicious pack (unresolved alert, suspected falsification) so it is not dispensed to a patient, pending the necessary checks. It is a key step in securing the pharmaceutical supply chain.
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