A drug ePedigree is a statement of origin that identifies each sale, trade or purchase of a drug, including the date of those transactions and the names and addresses of all parties to them.
The primary purpose of an ePedigree is to protect consumers from contaminated medicine or counterfeit drugs.
As the product moves through the supply chain each party involved is required to provide all previous ePedigree information and thereby insuring the lineage of every product.
The basic data elements of an original ePedigree include:
The ePedigree data models provide an integrated information architecture supporting the operations of companies with requirements to report and maintain ePedigree data:
Pharmaceutical Product | Order |
Product Instance | Confirmation |
Packaging | Authorization |
Transactions & Events | Reporting |
Related Party(s) | Restrictions |
Shipment | Documentation |
Regulatory Requirements |