Egypt

Regulation name

Egyptian Pharmaceutical Track & Trace System (EPTTS)

Serialization status

GS1 DataMatrix mandatory on secondary packaging (all companies) by Dec 31, 2018; phased “Track & Trace” rollout began in pilot form, moving toward full serialization and aggregation since 2024–25

Country population

~110 million

Alert requirement: Under development; EPCIS-based event capture and future alert handling by EDA

Aggregation requirement: Mandatory – Unit to case to pallet (parent-child relationship)

Track & Trace requirement: End-to-end EPCIS-based system in progress

Official governing body: Egyptian Drug Authority (EDA)

Serialization type / level: Secondary and tertiary required; primary optional / GTIN + SN + EXP + LOT on secondary; SSCC on tertiary;

MAH / CMO responsibilities: MAH or delegated 3PL/importer uploads data to EPTTS; packaging-level data is generated by the manufacturer/CMO

Serialized product scope: All pharmaceutical products: human, veterinary, herbal, supplements, antiseptics, insecticides / Rx, OTC, veterinary, herbal, imported and domestic – full market scope

Egypt

Alert requirement: Under development; EPCIS-based event capture and future alert handling by EDA

Aggregation requirement: Mandatory – Unit to case to pallet (parent-child relationship)

Track & Trace requirement: End-to-end EPCIS-based system in progress

Official governing body: Egyptian Drug Authority (EDA)

Serialization type / level: Secondary and tertiary required; primary optional / GTIN + SN + EXP + LOT on secondary; SSCC on tertiary;

MAH / CMO responsibilities: MAH or delegated 3PL/importer uploads data to EPTTS; packaging-level data is generated by the manufacturer/CMO

Serialized product scope: All pharmaceutical products: human, veterinary, herbal, supplements, antiseptics, insecticides / Rx, OTC, veterinary, herbal, imported and domestic – full market scope

Penalties for non-compliance: Not yet fully published; enforcement ongoing through phased implementation and future audits

Repackaging rules: Not explicitly defined; reserialization and re-aggregation required as per GS1 global practices

Serialization exemption rules: None officially documented; primary packaging may be exempted in practice but not formally stated

Market coding requirements:.

GS1 DataMatrix (GTIN, SN, EXP, LOT) on secondary packaging; SSCC (GS1-128/DataMatrix) on tertiary