• Register pharmaceutical products with ARCSA before placing medicines on the Ecuadorian market.

• Ensure packaging includes standardized barcode identification aligned with GS1 practices.

• Maintain batch level traceability records for manufacturing, importation, and distribution.

• Ensure distributors maintain shipment documentation that allows tracking of product batches.

• Maintain recall readiness by ensuring distribution records are accurate and accessible.

• Provide traceability information to ARCSA during regulatory inspections or product safety investigations.

Ecuador does not currently operate a nationwide pharmaceutical serialization repository that requires serial level reporting of supply chain events.

Traceability is supported through:

• Product identification using standardized barcodes
• Supply chain documentation maintained by manufacturers and distributors
• Regulatory oversight conducted by ARCSA

Companies must maintain traceability documentation that allows regulators to identify product batches and distribution pathways when required.

There is no regulatory requirement for aggregation or serialized packaging hierarchies in Ecuador.

Manufacturers and distributors may implement logistics identifiers such as SSCC internally to support warehouse operations and shipment tracking.

Aggregation practices are typically used for operational efficiency rather than regulatory compliance.

• Failure to include standardized barcode identification on pharmaceutical packaging.

• Mismatch between barcode data and printed product information.

• Incomplete distribution records that prevent effective product recall.

• Using inconsistent product identifiers across regulatory filings and packaging.

• Failure to maintain batch level traceability documentation across the distribution network.