Iniciativa de Trazabilidad Farmacéutica de la Junta de Farmacia y Venenos (PPB) (en desarrollo)
Serialization status
In progress — national traceability framework under development; pilot phase in early rollout, with multi-phase plan underway
Country population
~54 million
Alert requirement: Not yet active — expected to be included in future implementation phases
Aggregation requirement: Planned—unit→case→pallet aggregation included in roadmap, but not currently enforced
Track & Trace requirement: Planned—phased implementation; phase 1 focuses on batch-level visibility, later phases add serialization and full traceability
Official governing body: Pharmacy and Poisons Board (PPB), under Ministry of Medical Services
Implementation deadline / enforcement date: Phase 1 (12–48 months): basic visibility and batch repository; Phase 2 (48–72 months): unit-level serialization for high-risk products; Phase 3 (72–120 months): full serialization and advanced analytics
Serialization type / level: Multi-phase—batch-level first, moving to unit-level serialized DataMatrix and tertiary aggregation in later phases; Planned DataMatrix on secondary with GTIN, Batch, Expiry, Serial; tertiary to include SSCC
MAH / CMO responsibilities: In progress-MAH or their designee uploads data to national system during later implementation phases;
Serialized product scope: Phase 1 likely batch-level for essential drugs; Phase 2 extends to high-risk Rx/OTC; full coverage in final phase
Penalties for non-compliance: Not yet defined — expected to be included in final PPB regulations alongside each implementation phase
Repackaging rules: Not yet specified; serialization and aggregation likely required post-repackaging per GS1 norms
Serialization exemption rules: No exemptions currently listed; final guidelines expected to define limited exclusions per packaging level
