Unique Identifiers “UIs” are to be printed on all new packs, of mainly prescription medicines for human use, put on the market from the 9th February 2019 . The UI is in the form of a 2D data matrix, and (space permitting) in human readable form (printed in text adjacent to the barcode).
The UI is a unique 2D barcode made up of four key elements :
- Product Code
- Unique serialisation number
- Expiry dates
- Batch number
All the unique identifiers for a batch of product will be uploaded, through an on-boarding partner (OBP) by the manufacturer or parallel importer, to the European Hub when the product is released for sale. The UIs will then be given “active” status.
The UI contributes to patient safety by facilitating:
- Recall
- Withdrawal and Destruction
- Returns
- Pharmacovigilance
- Sampling
The packs should be decommissioned:
- At the point of dispensing to the patient.
- When Splitting a pack
- When exporting outside the European Union.
Packs must be able to be scanned after they expire to allow for the packs to be returned.