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PharmaliZr drug serialization
PharmaliZr drug serialization
Pricing News

Medicine traceability

Medicine traceability means following each unit of product, from its manufacturing to its dispensing to the patient. It is the foundation of pharmaceutical supply chain safety: without reliable traceability, there is no way to guarantee that a pack is authentic, nor to react effectively in the event of a batch recall or a suspected falsification.

What is medicine traceability?

Tracing a medicine means being able to precisely identify each pack and to know its journey: who manufactured it, which batch it belongs to, what its expiry date is and where it sits in the supply chain. This information relies on a unique identifier placed on each pack, encoded in a DataMatrix code readable by a barcode scanner.

Traceability serves several goals: fighting falsified medicines, making batch recalls reliable, securing stock and strengthening patients’ trust in the products dispensed to them.

Serialization is the technical mechanism that makes traceability possible at the level of each individual pack. By assigning a unique serial number to every unit and verifying it against a central repository, serialization turns “batch-level” traceability into “unit-level” traceability.

To learn more about how this works, see our dedicated page: What is drug serialization?.

The regulatory framework

Medicine traceability in Europe stems from Directive 2011/62/EU against falsified medicines and its Delegated Regulation (EU) 2016/161, applicable since 9 February 2019. These texts require two safety features on prescription medicine packs: the unique identifier and the anti-tampering device.

In France, verification is carried out through the national NMVS system, operated by France MVO and connected to the European hub. Each player — manufacturer, marketing authorisation holder, wholesaler, pharmacy — plays a precise role in the traceability chain.

The benefits of well-managed traceability

  • Patient safety: only authentic and untampered medicines are dispensed.
  • Regulatory compliance: meeting European and national obligations.
  • Recall management: immediate identification of packs affected by a batch recall.
  • Fraud prevention: detection of identifiers that are already decommissioned or unknown.

PharmaliZr: traceability made simple

PharmaliZr is the SaaS software that makes traceability accessible to every structure, without changing your dispensing software (PMS) or your hospital information system. Verification takes just a few seconds, directly in the browser, using a simple barcode scanner.

Do you have a question about bringing your organisation into compliance? Request a demo or read our frequently asked questions.