Chile

Regulation name
Pilot programs only (no national law yet) – e.g., voluntary GS1 pilots under ANAMED/ISP oversight
Serialization status
No, voluntary pilot programs involving GS1 DataMatrix and traceability standards, typically initiated by industry stakeholders alongside ANAMED/ISP. PLMR (D.S. 03, 2010)
Country population
19 million

Alert requirement: N/A

Aggregation requirement: N/A (pilots may test aggregation, but no mandate exists)

Track & Trace requirement: N/A

Official governing body: ISP (Instituto de Salud Pública) and ANAMED (Agencia Nacional de Medicamentos)—responsible for overseeing traceability, but currently limited to voluntary schemes

Serialization type / level:
Originally set April 28, 2022, but dropped after Bill 3846 and currently suspended: GTIN + ANVISA Medicine Registry Number (13-digit) + SN (13-digit) + EXP + LOT

Implementation deadline / enforcement date:

Voluntary pilot programs have rolling timelines, but no country-wide enforcement planned yet

MAH / CMO responsibilities: No legal serialization/reporting obligations outside of pilots. In pilot contexts, participants configure printing and data sharing under GS1 guidelines

Serialized product scope: RX and high risk/cost products

Penalties for non-compliance: N/A

Repackaging rules: N/A

Market coding requirements:

Not yet mandated.
Pilots follow GS1 best practices: GTIN + SN + EXP + LOT in DataMatrix or GS1-128

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