Legislative Decree No. 1161 (Law on Health Products), Supreme Decree No. 016-2011-SA (DIGEMID regulation)
Serialization status
Legislation in discussion
Country population
34 million
Alert requirement: N/A
Aggregation requirement: In progress
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: In progress
MAH / CMO responsibilities: In progress
Serialized product scope: In progress
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).
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