Interoperable exchange readiness confirmed for US-bound supply
Ergopharm has confirmed its readiness to support partners subject to the US Drug Supply Chain Security Act, whose enhanced requirements call for package-level traceability data exchanged electronically and interoperably.
DSCSA's later phase moved the industry from lot-level to package-level tracing, with transaction information exchanged in a secure, interoperable, electronic manner. For a manufacturer supplying into that chain, the practical requirements are a unique product identifier on each package, the ability to provide the associated data, and systems capable of responding to verification requests.
“One serialisation model serves every scheme. The obligations differ; the data does not.”
Ergopharm applies a serialised unique identifier to every carton and can supply the corresponding data through EPCIS exchange. Where a partner acts as the labeller or licence holder for the US market, the regulatory obligations sit with that partner; Ergopharm's role is to provide the data that lets them meet them.
The same underlying serialisation supports EU FMD safety features and other national schemes without a separate data model.
Key facts
- Requirement
- Package-level, interoperable electronic exchange
- Applied
- Unique identifier on every carton
- Exchange
- EPCIS to the partner's system
- Obligations
- Rest with the US labeller / licence holder
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.