Serialisation and Verification New

What do “serialisation” and “verification” mean?

  • Each pack of prescription medicine is given a unique serial number. This number is different for each pack (‘randomised’ = chosen at random).
  • This serial number, together with the batch number (i.e. the production or lot number) and the expiry date, is encoded in a two-dimensional barcode on the package.
  • The aim is to ensure that every package is uniquely identifiable within Europe.

Why is this done?

  • So that a package can be clearly traced in the supply chain — e.g. manufacturer → wholesaler → pharmacy/hospital → patient.
  • To ensure that no counterfeit medicines enter the legal supply chain.

What happens to serialised medicines?

  • When you receive a medicine, the serial number on the package is checked (‘verified’) – typically at the pharmacy, hospital or by a dispensing physician.
  • During this process, the serial number is checked against a database system and then decommissioned (marked as supplied). This helps ensure that the medicine is genuine and has not been falsified.
  • If any irregularities are detected during the verification process, the medicine must not be dispensed to the patient.

Who operates this system?

  • The system is operated by the Austria Medicines Verification System GmbH (AMVS GmbH).
  • It is a data storage and retrieval system for all prescription medicines marketed in Austria.
  • The Austrian system is connected to a central EU hub, together with all EU countries, the European Economic Area (EEA) and Switzerland.

Additional protective measures:

In addition to the serial number with barcode, each package must be equipped with a device (i.e tamper-evident seal) that indicates tampering with the outer packaging. In other words, it should be apparent whether the packaging has already been opened or altered.

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