Decreto Legislativo Nro. 1161 (Ley de Productos Farmacéuticos), Decreto Supremo Nro. 016-2011-SA (Reglamento de DIGEMID)
Serialization status
Legislation in discussion
Country population
34 million
Alert requirement: N/A
Aggregation requirement: En progreso
Track & Trace requirement: Law allows for traceability system, but implementation is pending – no digital portal or government data reporting tool is live
Official governing body: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), part of MINSA
Implementation deadline: No dedaline has been published yet. Expected during 2025, but not announced officially
Serialization type / level: En progreso
MAH / CMO responsibilities: En progreso
Serialized product scope: En progreso
Penalties for non-compliance: N/A
Repackaging rules: Allowed under DIGEMID supervision, following existing regulatory procedures — unrelated to serialization
Market coding requirements:
In Progress - expected to be GS1-standard:
GTIN + Serial Number + Batch + Expiry encoded in GS1 DataMatrix (planned).
