Safety-feature specification adopted

Commission Delegated Regulation (EU) 2016/161 was adopted on 2 October 2015 and published in the Official Journal on 9 February 2016. It supplements Directive 2011/62/EU, the Falsified Medicines Directive, by setting out the detailed rules for the two safety features that manufacturers must apply to the packaging of prescription medicines: a unique identifier carried in a two-dimensional barcode, and an anti-tampering device. The Regulation establishes a three-year transition, with its provisions becoming generally applicable from 9 February 2019.

“The safety-feature characteristics defined by the Regulation have been written into Ergopharm's artwork masters and packaging specifications, so that European-bound cartons are engineered for serialised verification from the outset.”

The unique identifier defined by the Regulation comprises a product code, a serial number generated by a randomised or otherwise unpredictable algorithm, a batch number and an expiry date, together with a national reimbursement number where a Member State requires one. These data elements are to be encoded in a GS1 DataMatrix (ECC200) and, with the exception of the product code and serial number where a specific format is prescribed, printed in human-readable form on the pack. The Regulation also fixes the maximum length of the serial number and the way each element is delimited, so that packs can be read and verified consistently across the Union.

Ergopharm has incorporated these characteristics into its own artwork templates and packaging specifications at Tandalja, Vadodara. Cartons intended for European destinations now carry a GS1 DataMatrix populated with Application Identifiers for GTIN (01), expiry (17), batch (10) and serial (21), with the corresponding data reproduced in plain text beneath the code. Print positions, quiet zones and minimum contrast have been defined in the artwork masters so that grading and verification can be performed at the line, and serial-number ranges are drawn from an unpredictable source in keeping with the Regulation's requirement.

In parallel, Ergopharm has specified an anti-tampering device for the affected cartons, using tamper-evident closure features that give visible evidence should a pack be opened before it reaches the patient. These specifications describe Ergopharm's own packaging and process design; they do not constitute, and should not be read as, any national marketing approval. All timelines referenced here follow the transition set by the Regulation itself, and full serialised release under a verification system will follow as the applicable date approaches.