Packaging roadmap reviewed against the Falsified Medicines Directive
Ergopharm has completed an internal review of its packaging roadmap against Directive 2011/62/EU, the European Union's newly published Falsified Medicines Directive, mapping the changes its own artwork, coding and serialisation processes will need over the coming years.
Directive 2011/62/EU was published in the Official Journal of the European Union on 1 July 2011 and enters into application on 2 January 2013. It amends the Community code on medicinal products for human use to counter falsified medicines entering the legal supply chain. Central to the Directive is a requirement for prescription medicines to carry safety features that allow verification of authenticity and identification of individual packs, together with a device that shows whether the outer packaging has been tampered with. The technical detail of those features will follow in delegated acts to be adopted by the European Commission, so the exact data model and scope are not yet fixed.
“Ergopharm's aim is that any line we build or refurbish from now on can accept a serialised 2D code and a tamper-evident seal without later rework.”
Because Ergopharm manufactures for export, the Directive is not a marketing-authorisation matter for the company but a design target for its packaging and coding lines. Our review set out to understand what a serialised, verifiable pack will require, and to ensure that lines commissioned or refurbished from now on are built to accept a two-dimensional barcode and an anti-tampering seal without later rework. The roadmap treats the two safety features as separate work streams: a unique-identifier coding capability, and a tamper-evidence capability on the outer carton.
On the coding side, the review confirmed our intention to standardise on a GS1 DataMatrix carrying structured application identifiers, so that a pack can express its product code, batch, expiry and a unique serial number in a single machine-readable symbol. This aligns our own artwork templates, vision-inspection points and data-capture steps with an open, internationally used standard rather than a proprietary format, and keeps our options open while the Commission's delegated acts are drafted.
The roadmap is deliberately staged. Near-term work focuses on artwork readiness and print quality so that cartons leave sufficient clear space and contrast for a reliable DataMatrix; medium-term work covers serialisation data management and aggregation of packs into cases; and the tamper-evidence device is being evaluated against carton designs already in use. All timings in the roadmap are illustrative and will be reconciled with the final requirements once the delegated legislation is published.
Key facts
- Instrument
- Directive 2011/62/EU (Falsified Medicines Directive)
- Published
- 1 July 2011, Official Journal of the EU
- Applicable from
- 2 January 2013
- Safety features
- Unique identifier (2D barcode) plus anti-tampering device
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.