Safety features live across the portfolio

The two features work together. The unique identifier is printed as a GS1 DataMatrix (ECC200) and carries, in machine-readable form, the product code (GTIN), batch or lot number, expiry date and a randomised serial number unique to each pack. The anti-tampering device is a physical seal on the carton that gives a visible indication if the pack has been opened between our release and the patient. One confirms that a pack is what it claims to be; the other shows whether it has been interfered with since it left our line.

“Every outer carton now carries a unique, verifiable identifier and a tamper-evident seal, so a pack's authenticity and integrity can be confirmed at the point of dispense.”

For distributors and pharmacists, the practical effect is straightforward. A carton can be scanned and its identifier checked against a verification system, and the tamper seal can be inspected by eye before the pack is handed over. Serialisation at the pack level also allows individual units to be traced through the chain rather than only by batch, which supports faster, more precise action if a specific pack ever needs to be located or withdrawn.

The framework behind these features is the EU Falsified Medicines Directive (2011/62/EU) and Commission Delegated Regulation (EU) 2016/161, whose requirement for the two safety features became applicable on 9 February 2019. As an India-based manufacturer producing for export, Ergopharm has aligned its packaging and data processes to that standard so that products presented into markets operating point-of-dispense verification arrive already carrying compliant identifiers and seals.

Operationally, serialisation is applied inline during packaging and the printed data is verified before a pack is released. Serial numbers are managed so that each is unique and unrepeated, and aggregation of packs into cases can be recorded as EPCIS events, linking each unit to its case for onward handling. Quality release remains under the existing Batch Manufacturing Record and Certificate of Analysis process; the safety features add an identity-and-integrity layer on top of the controls already in place, and now cover every item on the register without exception.