Ley Orgánica de Salud (1998); no decree mandating serialization or traceability
Serialization status
N/A
Country population
28 million
Alert requirement: Standard pharmacovigilance and market surveillance in place (MPPS/SACS/INCANAM) – not tied to serialization
Aggregation requirement: N/A
Track & Trace requirement: N/A
Official governing body: MPPS (Ministerio del poder popular para la salud, Ministry of Popular Power for Health) through entities like SACS and INCANAM
Implementation deadline: Not scheduled
Serialization type / level: N/A
MAH / CMO responsibilities: N/A
Serialized product scope: N/A
Penalties for non-compliance: N/A
Repackaging rules: Standard GMP and labeling rules apply; repackaging allowed under SACS guidance, unrelated to serialization
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