Safety features applied per Regulation (EU) 2016/161
From 9 February 2019, the two safety features required under the EU Falsified Medicines Directive become applicable across the European Union. Ergopharm confirms that affected packs manufactured for that market now carry a unique identifier in a 2D DataMatrix together with an anti-tampering device on the outer carton.
The legal framework rests on Directive 2011/62/EU, the Falsified Medicines Directive, which was published on 1 July 2011, and on Commission Delegated Regulation (EU) 2016/161, which sets out the detailed rules for the two safety features. Those features are a unique identifier carried in a machine-readable 2D DataMatrix and an anti-tampering device that gives visible evidence where a carton has been opened. Under the Delegated Regulation, both features are applicable from 9 February 2019, from which date affected prescription medicines placed on the EU market are expected to carry them.
“Each affected export pack now leaves the line bearing a unique serialised identifier in a GS1 DataMatrix and a visible anti-tampering device, applied as a routine part of Ergopharm's packaging operation.”
Ergopharm has aligned its own packaging and coding processes accordingly. The unique identifier is encoded in a GS1 DataMatrix (ECC200) using GS1 Application Identifiers for the product code (01, GTIN), expiry (17), batch or lot (10) and a randomised serial number (21), so that each pack carries a distinct serialised GTIN. Human-readable equivalents of these data elements are printed alongside the code, and the anti-tampering device is applied to the outer carton as part of the same packaging operation.
Serial numbers are generated and reconciled within Ergopharm's serialisation and aggregation workflow, in which pack-level identifiers are associated with case and pallet units for onward handling. The point-of-dispense verification and decommissioning of a unique identifier are functions of the European Medicines Verification System; Ergopharm's responsibility, as manufacturer, is to apply the two safety features correctly and to make the pack data available for that system to check.
These coding and tamper-evidence steps sit inside the company's pharmaceutical quality system, covered by the relevant Batch Manufacturing Record and released under Qualified Person oversight. The measures described here concern Ergopharm's own packaging and process controls; they align the company's export packs with the requirements of Regulation (EU) 2016/161 and make no claim to any national marketing approval.
Key facts
- Legal basis
- Directive 2011/62/EU (FMD) + Commission Delegated Regulation (EU) 2016/161
- Applicable from
- 9 February 2019
- Two safety features
- Unique identifier in a 2D DataMatrix + anti-tampering device
- Data carrier
- GS1 DataMatrix (ECC200): AIs (01) GTIN, (17) expiry, (10) batch, (21) serial
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.