Unique identifier: serialised code on prescription medicine packs

The unique identifier is one of the two safety features required by Article 54(o) of Directive 2001/83/EC, as inserted by the Falsified Medicines Directive, and specified in Commission Delegated Regulation (EU) 2016/161. It is carried in a two-dimensional Data Matrix barcode and contains a product code, a serial number of up to twenty characters, the batch number and the expiry date, plus a national reimbursement or identification number where the Member State requires one. The same data elements are printed in human-readable form next to the code, except where pack size makes that impossible.

The manufacturer generates the serial numbers randomly, prints the code on the outer packaging, and the marketing authorisation holder uploads the identifiers to the European hub before the batch is released for sale, from where they are routed to the national repositories of the Member States where the product is to be sold. The product code, normally a GTIN or a national PPN, is tied to the specific presentation, so a new pack size or a change of holder means a new product master data record in the repository as well as a variation.

Verification is a two-step check: the pack's authenticity against the repository, and its status, which must be active rather than decommissioned, recalled, withdrawn or expired. Wholesalers verify on a risk basis, for example for returns and for products not received from the manufacturer or a designated wholesaler. Pharmacies and hospitals verify and decommission at supply. A pack that fails verification generates an alert that the holder, the national organisation and the authority must investigate before the pack is released or quarantined.

What goes wrong: packs printed before the master data was loaded, so every scan fails; codes placed under a sleeve or across a fold; serial numbers reused across batches; artwork approvals that do not include the code position; and a transfer of holder that forgets the repository registration. False alerts also arise from scanner configuration, and every alert has to be closed, which takes time the launch plan rarely includes. Keeping the product master data, the artwork and the variation history in step is the practical answer.