Libya

Regulation name

Decision No. 379/2023 on Pharmaceutical & Medical Device Serialization

Serialization status

In progress – regulation enacted in 2023; implementation phase started late 2024.

Country population

~7 million

Alert requirement: Not yet defined; likely centralized under Customs ACI enforcement and Ministry of Economy systems.

Aggregation requirement: Parent-child aggregation expected (unit → case → pallet), supported through GS1-128/DataMatrix for tertiary packaging

Track & Trace requirement: Yes – end-to-end serialization and aggregation for pharmaceuticals and medical devices entering the market.

Official governing body: Ministry of Economy and Commerce (Libya), possibly cooperating with Customs and GS1.

Implementation deadline / enforcement date: Decision No. 379 issued in 2023; Advance Cargo Information (ACI) in force since Nov 1, 2024 for imports. Serialization enforcement expected throughout 2025

Serialization type / level: Secondary packaging: GTIN, Serial Number, Batch/Lot, Expiry. Tertiary: SSCC via GS1-128/DataMatrix

MAH / CMO responsibilities: MAH or delegated importer/3PL transmits through Libya’s customs ACI and Ministry systems.

Serialized product scope: All registered Rx and OTC medicines, and medical devices entering or produced in Libya.

Penalties for non-compliance: Products without valid GS1 DataMatrix or ACI documentation are barred from entry and trade. Shipments rejected at origin or on arrival.

Repackaging rules: Not explicitly defined; repackaged goods must incorporate GS1 identification and re-validate through ACI and Ministry customs systems

Serialization exemption rules: None currently defined—no formal exemptions documented; all secondary units and imports require compliance.

Market coding requirements:

GS1 DataMatrix mandatory on sellable units (secondary packaging): GTIN, Serial Number, Batch/Lot, Expiry date. Tertiary aggregation encouraged similarly.

Spanish