European distribution partnerships expanded
Ergopharm has onboarded additional distribution partners in European markets, each requiring market-specific labelling and serialisation data exchange arrangements agreed before first supply.
European supply raises requirements that other markets do not, principally the safety features introduced by the Falsified Medicines Directive: a unique identifier carried in a two-dimensional barcode and an anti-tampering device on the outer carton. Ergopharm applies both; uploading the unique identifiers to the European repository system is performed by the marketing-authorisation holder in that market, not by the manufacturer.
“We print the identifier. Uploading it is the licence holder's obligation, and we are careful about the difference.”
Each partnership begins with verification of the partner's wholesale distribution authorisation, a quality agreement, a safety data exchange agreement covering pharmacovigilance responsibilities, and agreement on artwork in the language of supply.
Ergopharm's role is manufacture and documentation support; registration and the obligations that follow from it rest with the local licence holder.
Key facts
- Safety features
- Unique identifier and anti-tampering device applied
- Repository upload
- Performed by the local marketing-authorisation holder
- Agreements
- Quality agreement and safety data exchange agreement
- Artwork
- Language of the country of supply