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Ecuador Regulatory

Regulatory For

Pharma

Regulatory AgencyARCSA is the legal authority that issues and enforces traceability and
serialization regulations for medicines, biological products, and
medical devices in Ecuador.
Regulation NameARCSA traceability directives.
Compliance Dates

Although staged implementation deadlines were initially proposed
(starting from late 2022 into 2024), various industry sources indicate
that the formal enforcement of serialization infrastructure and
reporting to a live national system may still be pending or evolving.
Actual deployment of ARCSA’s database and national reporting backbone
remains a work in progress.

Applies toThe regulation applies to the entire pharmaceutical supply chain —
including:

 

  • Manufacturers (local and foreign products entering Ecuador)
  • Importers and distributors
  • Pharmacies and public healthcare entities
  • Logistics and transportation operators

All medicines, biological products, and certain related healthcare goods
must comply with traceability requirements when distributed within the
Red Pública Integral de Salud (RPIS) and other sectors of the national
healthcare system.

Free Samples must be marked? No

SECONDARY PACKAGING

(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)

Barcode Symbology Two-dimensional barcodes (e.g., GS1 DataMatrix) are required to encode the CUT on primary and/or secondary packaging, ensuring visibility and readability. When package size does not permit direct barcode placement, tamper-evident stickers carrying the CUT may be used.
Barcode Content

Each medicinal product must carry a Unique Traceability Code (CUT) which includes the following key elements:

  • GTIN (Global Trade Item Number)
  • Batch / Lot Number
  • Expiration Date
  • Unique Serial Number (where applicable)
Serial Number RandomizationNA
Serial Number Reuse

No

Human Readable Expiry Date Format

YYMMDD

Barcode Data Encoding

GS1 Standard

Product Code Notes NA
Free Samples must be marked?

No

AGGREGATION DATA CAPTURE

Parent-Child Mapping Aggregation Capture?
 Yes — Ecuador mandates parent-child (aggregation) capture to maintain hierarchical packaging relationships as part of ARCSA’s pharmaceutical traceability requirements.

DATA EXCHANGE

Send Unit Data to Government Repository? Yes — required , The National Traceability System mandates that all
logistical movements of products, including unit tracking data, be
recorded in ARCSA’s traceability information system.
Send Unit Data to Third-Party Repository?

Not specifically mandated. The official regulation only defines
the national traceability system with ARCSA’s database as the
platform for traceability records. It does not require reporting
to third-party commercial repositories.

Send Unit Data to Trading Partner?

Not mandated by ARCSA itself.

  • The regulation requires capturing unit traceability information, but
    does not explicitly require exchange of unit data with trading
    partners under the law; partners are expected to manage their own
    internal records.
Send Aggregation Data to Government Repository?


Yes — through the traceability system.

  • All operations and movements — including those involving aggregated
    packaging levels (pallets, cartons, etc.) — must be registered in
    the traceability system.
Send Aggregation Data to Third-Party Repository?

Not required by regulation.

  • The law does not prescribe third-party database submission; focus is
    on capturing aggregation within the ARCSA traceability framework.
Send Aggregation Data to Trading Partner?

Not a statutory requirement.

  • As with unit data, internal aggregation data sharing with partners
    is a business practice, not a mandated legal obligation under
    Ecuador regulations.

AUTHENTICATION

Who Offers Data Repository for Authentication?


ARCSA is the central authority.

  • Ecuador’s traceability rules establish a national traceability
    system     managed by ARCSA, which functions as the central traceability
    database.
Manufacturers Must Register Shipments in Repository?


Yes — they must record traceability events.

  • The regulation requires that all supply chain actors (manufacturers,
    importers, etc.) record movements in the system, which includes
    shipment events.
Downstream Trading Partners Must Authenticate on Receipt?


The regulation requires registering receipt movements.

  • Downstream partners must capture and record the reception of
    products     in the traceability system. While not called “authenticate”
    in those terms, reception events are part of traceability logging.
Downstream Trading Partners Must Authenticate on Shipment?


Yes — as part of movement logging.

  • Similarly, shipment (dispatch) events must be recorded by
    logistics/receiving partners as part of ongoing traceability.

GOVERNMENT REPORTING

Manufacturer Activity Reported? Yes — operational activities logged.

 

  • All logistical operations throughout the supply chain — including
    manufacturing, storage, distribution — are logged in the system
Downstream Trading Partner Activity Reported?

Yes — required.

  • All entities in the national traceability system (distributors,
    pharmacies, logistics) must register traceability events for
    products as they move through the supply chain.
Source and Credit: This information is fully or partly based on the GS1 master document (all rights reserved). As GS1 does not control the content of the information, GS1 shall not be held liable, under any circumstance, if it differs from the master document.

DISCLAIMER

This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.

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Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.

Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.

For Further Information, please contact our Compliance Team at info@kevision.in

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