Mandato dell'Agenzia nazionale per i prodotti farmaceutici in materia di tracciabilità
Stato della serializzazione
In progress – full rollout planned by Jan 1, 2027
Popolazione del Paese
~44 million
Requisiti per l'avviso: Not yet defined; likely centralized via ANPP—details pending
Requisiti di aggregazione: 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
Requisiti di tracciabilità: Full T&T required: serialization + aggregation + EPCIS-ready reporting by 2027
Tipo/livello di serializzazione: Mandatory at secondary (saleable unit) and tertiary (bundle, case, pallet) levels; primary optional/per guidelines. Secondary & tertiary: GTIN + SN + batch + expiry encoded
Responsabilità del responsabile del marketing e delle operazioni (MAH) / Direttore marketing (CMO):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.
Ambito di applicazione dei prodotti serializzati: All pharmaceutical products manufactured in or imported into Algeria Rx and OTC
Sanzioni in caso di inadempienza: Not yet published – ANPP expected to define enforcement procedures and penalties closer to the 2027 enforcement date
Norme relative al reimballaggio: Not formally published. However, based on global GS1 practices, any repackaged product will likely require re-serialization and updated aggregation before distribution.
Norme relative alle esenzioni dalla serializzazione: 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
Requisiti di codifica di mercato:
GS1 DataMatrix with GTIN, Serial Number, Batch/Lot, Expiry encoded on secondary packaging; packing levels require aggregation
