Ecuador

Regulation name

ARCSA-DE-030-2020-MAFG (replaced by ARCSA-DE-010-2021-LDSS)

Serialization status

Serialization legally required since Dec 2020, but not enforced in practice as of 2025

Country population

18 million

Alert requirement: Defined on paper but no functional national alert system active

Aggregation requirement: Legally required (SSCC-based), not enforced

Track & Trace requirement: Mandated by law, but no actual reporting system has been implemented

Official governing body: ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria)

Serialization type / level: Primary, secondary, tertiary packaging; GTIN + SN + batch + expiry; GTIN DataMatrix on all levels

MAH / CMO responsibilities: MAH responsible for serialization/reporting, CMOs under MAH oversight; not enforced

Serialized product scope: Medicines (ARCMB-listed Rx & OTC), biologics, selected medical devices; pilot limited to RPIS supply

Penalties for non-compliance: N/A

Repackaging rules: Packaging changes allowed with ARCSA notification, no re-registration needed

Market coding requirements:

GTIN + Serial Number + Batch + Expiry in GS1 DataMatrix / linear barcodes (on paper only)

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