Key terms and definitions for pharmaceutical supply chain security compliance.
DSCSA (Drug Supply Chain Security Act)
US federal law enacted in 2013 requiring pharmaceutical manufacturers, wholesale distributors, dispensers, and repackagers to implement serialisation, electronic transaction documentation, and EPCIS-b... Read more →
EPCIS (Electronic Product Code Information Services)
GS1 standard for sharing supply chain event data. EPCIS events capture what, when, where, and why for each step in the pharmaceutical supply chain. Required for DSCSA interoperability from November 20... Read more →
SGTIN (Serialised Global Trade Item Number)
GS1 standard for uniquely identifying individual pharmaceutical products. An SGTIN combines a GTIN (identifying the product type) with a serial number (unique to each individual pack).... Read more →
FMD (Falsified Medicines Directive)
EU Directive 2011/62/EU requiring prescription medicines to carry a unique identifier and tamper-evident features. Verified against the European Medicines Verification System (EMVS) at the point of di... Read more →
EMVS (European Medicines Verification System)
Pan-European repository of unique identifiers for prescription medicines. Consists of the European Hub (managed by EMVO) and national medicines verification systems (NMVSs) in each EU member state.... Read more →
Serialisation
The process of assigning a unique identifier to each individual saleable unit of a pharmaceutical product. The unique identifier is encoded in a 2D barcode (DataMatrix) on the packaging.... Read more →
ATP (Authorised Trading Partner)
Under DSCSA, a manufacturer, wholesale distributor, or dispenser that holds a valid state licence or FDA registration. DSCSA requires pharmaceutical companies to only transact with authorised trading ... Read more →
NMPA (National Medical Products Administration)
China's national regulatory authority for pharmaceutical products, medical devices, and cosmetics. The NMPA operates China's national drug traceability system requiring serialisation and reporting for... Read more →