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Canada Regulatory

Regulatory Agency Health Canada — the federal regulator for pharmaceuticals, responsible for product safety, labelling, and broader regulatory compliance (including barcoding transitions).
Regulation Name There is no specific Canadian serialization law yet — instead, the industry is guided by the GS1 Canada Pharmaceutical Barcoding Roadmap recommending full GS1 DataMatrix adoption and traceability capabilities across stakeholders.
Compliance Dates Canada’s national GS1 DataMatrix implementation timeline is voluntary and community-led:
  • Manufacturers: readiness expected by 31 Dec 2023
  • Distributors: readiness by 31 Dec 2023
  • Pharmacies: readiness by 31 Dec 2025 (serial numbers in barcodes are optional, but GTIN + lot + expiry is recommended)
Applies to All categories of pharmaceuticals marketed in Canada — prescription, OTC, behind-the-counter, and natural health products — are included in the barcoding roadmap.

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 GS1 DataMatrix (2D) is recommended as the primary barcode on saleable units at both the primary and secondary packaging level. Linear barcodes may be included during transition, but the GS1 DataMatrix is the future-oriented standard.
Barcode Content Barcode Content
For GS1 DataMatrix under the Canadian roadmap:
  • GTIN (mandatory)
  • Lot / Batch number (mandatory)
  • Expiry Date (mandatory)
  • Serial number (optional) — recommended if used for global markets.
Serial Number Randomization Serial numbers are optional in Canada’s roadmap, but if used, they are generally expected to follow GS1 standard practices (randomized unique values) to ensure uniqueness across units.
Serial Number Reuse

Canada’s recommended practice for GS1 barcoding does not support reuse of serial numbers within the same GTIN scope; this follows GS1 global guidance although it is not an explicit Canadian regulatory mandate.

Human Readable Expiry Date Format

GS1 standards (as used in the Canadian roadmap) require that expiry dates appear in a human-readable format adjacent to barcode — typically YYYYMMDD or as defined in GS1 specs.

Barcode Data Encoding

Data must be encoded in GS1 Application Identifiers using a GS1 DataMatrix (ISO/IEC 16022) compliant with GS1 General Specifications.

Product Code Notes

Canada’s roadmap calls for unique GTINs at primary and secondary levels. The roadmap supports alignments with global standards and data capture for patient safety, but does not currently mandate aggregation or reporting.

Free Samples must be marked?

No

AGGREGATION DATA CAPTURE

Parent-Child Mapping Aggregation Capture?
 No mandatory requirement currently exists.
Canada’s barcoding roadmap does not require aggregation capture (parent-child packaging relationships) as part of the formal recommendations, though companies may use it voluntarily for internal traceability.

DATA EXCHANGE

Send Unit Data to Government Repository? Canada does not yet have a national serialization data repository (e.g., like the US DSCSA or EU EMVS). The roadmap focuses on barcode adoption and scanning capabilities, not repository reporting.
Send Unit Data to Third-Party Repository?

Not mandated.
Data exchange with third-party systems is voluntary and driven by business needs (e.g., supply chain partners) rather than regulatory obligation.

Send Unit Data to Trading Partner?

Not mandated by regulation.
While sharing unit data may be advisable for internal traceability, the Canadian framework does not require trading partner reporting.

Send Aggregation Data to Government Repository? Not applicable.
No centralized government repository exists yet; thus there is no requirement to send aggregation data to one
Send Aggregation Data to Third-Party Repository?

Not required.
Sharing of aggregation data with third parties is a business-level decision, outside any Canadian legal mandate.

Send Aggregation Data to Trading Partner?

Not required.
Sharing of aggregation data with third parties is a business-level decision, outside any Canadian legal mandate.

AUTHENTICATION

Who Offers Data Repository for Authentication? Not mandated.
Manufacturers Must Register Shipments in Repository?

No central Canadian repository currently exists.

Downstream Trading Partners Must Authenticate on Receipt?

No — not required.
Downstream Trading Partners Must Authenticate on Shipment? Not required by current Canadian standards.

GOVERNMENT REPORTING

Manufacturer Activity Reported? No mandatory reporting.
Downstream Trading Partner Activity Reported?

No.
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.

ABOUT KEVISION SYSTEMS

Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.

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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