National Agency for Pharmaceutical Products traceability mandate
Serialization status
In progress – full rollout planned by Jan 1, 2027
Country population
~44 million
Alert requirement: Not yet defined; likely centralized via ANPP—details pending
Aggregation requirement: Although official enforcement is post-2027, ANPP’s draft guidelines already mandate bundle–case–pallet aggregation using GS1-128 or DataMatrix. This is part of a comprehensive GS1-based framework entered into during pilot phase; it ensures systems are ready for full-level aggregation when enforcement begins
Track & Trace requirement: Full T&T required: serialization + aggregation + EPCIS-ready reporting by 2027
Serialization type / level: Mandatory at secondary (saleable unit) and tertiary (bundle, case, pallet) levels; primary optional/per guidelines. Secondary & tertiary: GTIN + SN + batch + expiry encoded
MAH / CMO responsibilities:MAH (Marketing Authorization Holder) is responsible for compliance reporting to national authorities. In practice, **MAHs may delegate technical reporting tasks to third parties (e.g., 3PLs, importers, authorized local agents)**. Final transmission to ANPP will follow EPCIS standards.
Serialized product scope: All pharmaceutical products manufactured in or imported into Algeria Rx and OTC
Penalties for non-compliance: Not yet published – ANPP expected to define enforcement procedures and penalties closer to the 2027 enforcement date
Repackaging rules: Not formally published. However, based on global GS1 practices, any repackaged product will likely require re-serialization and updated aggregation before distribution.
Serialization exemption rules: No official exemptions have been published; products in small primary packaging may be practically exempted from serialization due to space constraints, but this is not formally documented
Market coding requirements:
GS1 DataMatrix with GTIN, Serial Number, Batch/Lot, Expiry encoded on secondary packaging; packing levels require aggregation