Unique Identifier (UI): A unique alphanumeric code assigned to each individual pack of a serialized medicinal product. The UI allows for tracking and tracing the product’s movement throughout the supply chain, aiding in the detection and removal of FMPs. UIs are crucial for ensuring the integrity of the supply chain and patient safety.
The unique identifier is represented by a 2D data matrix code and human readable information placed on medical products that can be scanned at fixed points along the supply chain.
The unique identifier comprises:
- a product code which allows the identification of at least:
- the name of the medicine,
- the common name
- the pharmaceutical form
- the strength, the pack size
- the pack type
- a serial number which is a numeric or alphanumeric sequence of a maximum of 20 characters randomly generated
- a batch number
- an expiry date
Upon supply to the patient, the unique identifier must be ‘decommissioned’ via a scan from the FMD system, to prevent any duplication of a legitimate identifier for use on a falsified medicine.
To enable this manufacturers upload valid UI codes to the European Medicines Verification System (EMVS) via the European Medicines Verification Organisation (EMVO) and supply chain stakeholders / pharmacies will be able to check the status of each pack at any point along the supply chain and during the dispensing process via their interface with appropriate National Medicines Verification Systems (NMVS).
Implementation is underway, including in some non-EU countries (such as in UK, Switzerland).
