Peru

Regulation name

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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