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Implementation Roadmap

GS1 DataMatrix Barcodes on Pharmaceuticals in Canada

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As the world celebrates the 50th anniversary of the barcode, Canada is advancing action to align with the global movement for the adoption of GS1 DataMatrix (2D barcodes) on pharmaceuticals. All categories of pharmaceuticals are included — prescription drugs, over-the-counter (OTC), behind-the-counter and natural health products (NHP)*.

Patient safety, best practices in dispensing to patient record workflow, improvements to supply chain traceability capabilities, and the elimination of pharmaceutical barcode relabelling are the strategic imperatives driving this movement.

The Roadmap to the Implementation of GS1 DataMatrix Barcodes on Pharmaceuticals in Canada guides the community-led 2025 deadline for system-wide capabilities in Canada to scan, store and process the GS1 DataMatrix barcode that contain the Global Trade Item Number (GTIN - the number below the barcode), lot number and expiry date (serial number is optional).

Readiness expectations apply to all relative stakeholders and their solution providers:

*It is recognized that the transition to a single GS1 DataMatrix barcode for Behind-the-Counter (BTC), Over-the-Counter (OTCs) and Natural Health Products (NHPs) will align with the global movement for consumer goods, and in alignment with the Global 2D Migration program.

Additionally, medical devices sold at the retail level will also align with the Global 2D Migration program movement for consumer goods.

Discussions about the global movement toward 2D barcodes for consumer goods and foods are underway, and readiness timelines are expected to extend beyond 2025. Canadian timelines will be established through GS1 Canada’s community management process. Should manufacturers of BTCs, OTCs, NHPs, and medical devices wish to voluntarily adopt GS1 DataMatrix in advance of the pending global timelines, then manufacturers are encouraged to prioritize those products with the potential to be dispensed due to a prescription (for example, some shampoos, OTCs and diabetes test strips can be prescribed and dispensed or administered while in hospital or Long-Term Care).

Additionally, manufacturers are encouraged to follow the GS1 DataMatrix Roadmap for product samples. Samples that have the potential to be recalled or to be dispensed in a clinic or hospital setting require traceability and therefore benefit from effective barcoding.

To support the transition period for distributors and pharmacies, two barcodes are recommended to be included (linear and GS1 DataMatrix) at the saleable unit level. The exception is for products without an existing barcode or where there is small usable space, in which case a GS1 DataMatrix should be used.

Concerns for safety have given rise to the urgent and strategic request for greater supply chain visibility capabilities enabled through global standards, including barcodes. With the reality that medical errors are the third leading cause of death in North Americai, combined with the COVID-19 crisis exposing the vulnerabilities linked to significant lack of visibility in the supply chain and resulting challenges with drug shortages, the pharmacy community is advancing a pharmaceutical barcoding implementation action plan and a corresponding government relations strategy.

Global leaders of pharmaceutical manufacturing, including the United States, European Union and India, all have regulations with specific deadlines to deliver critical data such as the Global Trade Item Number, lot number and expiry date within one globally-standardized barcode. Considering more than half of Canadian pharmaceutical production is exported and over 78% of the Canadian pharmaceutical market is supplied by imports from the US and EUii, Canada is in a strong position to leverage manufacturer readiness in a significant way.

Canada’s goal is that only one GS1 DataMatrix barcode will be on pharmaceutical products at both the primary and secondary packaging level. This level of barcode readiness will enable:

  • Reduction in medical errors and improvements in patient care outcomes
  • Traceability capabilities for each product right down to bedside scanning and the patient record
  • Lot-based product recalls to the inventory and patient level
  • Elimination of risk and resources dedicated to barcode re-labelling at the primary and secondary packaging level
  • Forecasting data to mitigate shortages
  • Predictive analytics for clinical outcomes and value-based procurement
  • Visibility into the supply chain for inventory management
  • Reduction of waste and costs
  • Prevention of fraudulent or poor-quality product entering Canada’s supply chain

It is important to note that the roadmap was established subsequent to various requests including, individual GPO, retailer, distributor and healthcare provider requests, in addition to recommendations from ISMP/CPSI Joint Technical Statement for medication barcoding and the Public Health Agency of Canada’s recommendations for vaccines. Endorsement for this action has been reinforced for many years by Canada’s leading healthcare associations.

i Makary MA, Daniel M. Medical error - the third leading cause of death in the US. BMJ. 2016;353:i2139

ii Statistics Canada, Industry Canada trade - online data

Implementation Requirements and Timelines

Manufacturers

Shall:

  • Affix a GS1 DataMatrix barcode to primary and secondary packaging
  • Permanently assign a unique GTIN to each packaging level
  • Assign and, where feasible, mark a GTIN to the Unit of Use level
  • Affix a GS1-128 at the case level and accept the addition of an optional GS1 DataMatrix — both barcode symbologies must contain the same GTIN
  • Barcodes include static and variable data as noted below:

Static Data:

  • GTIN

Variable Data:

  • Lot Number
  • Expiration Date
  • Serial Number (optional)*

Implementation Timeline: Dec 31, 2021 to Dec 31, 2023**

What do manufacturers need to do to determine if they are prepared?

  • Assess printing software - conformance to ISO / IEC 16022 standard and GS1 General Specifications
  • Assess if packaging material is suitable to carry a barcode
  • Verify if GTINs are:

* Including serialized data is optional, however it is recommended that manufacturers who include serialized data in barcodes to meet regulatory requirements for other countries should include serialized data in the barcodes destined for Canada.

** For manufacturers who currently do not have production lines with variable data such as lot and expiry, the implementation deadline recommendation is a phased approach between 2021 to 2023. It is recognized that the transition to a single GS1 DataMatrix barcode for over-the-counter and natural health products will align with the global movement for consumer goods, and in alignment with the Global 2D Migration program. These timelines are yet to be announced, and expected to extend beyond 2025. To support the transition period for distributors and pharmacies, two barcodes are recommended to be included at the handling level (linear and GS1 DataMatrix), except for products whereby a barcode does not exist today or where there is small usable space, a GS1 DataMatrix should be used.

Distributors

Shall be able to scan, store and process into legacy ERP, ordering and distribution systems:

  • A GS1 DataMatrix for the primary and secondary packaging
  • Unique GTINs at each packaging level
  • GTINs at the Unit of Use level
  • GS1-128 at the case level
  • Barcodes include static and variable data as noted below:

Static Data:

  • GTIN

Variable Data:

  • Lot Number
  • Expiration Date
  • Serial Number (optional)*

Implementation Timeline: December 31, 2023

What do distributors need to do to determine if they are prepared?

  • Assess scanning equipment - confirming camera-ready barcode scanning equipment is in place to read both linear and 2D barcodes
  • Verify if databases and systems are:
  • Plan for future: establish a plan to scan and store serialized data in your internal systems

Pharmacies

Shall be able to scan, store and process into legacy ERP, PPMS and EMRs:

  • A GS1 DataMatrix for the primary and secondary packaging
  • Unique GTINs at each packaging level
  • GTINs at the Unit of Use level
  • GS1-128 at the case level
  • Barcodes include static and variable data as noted below:

Static Data:

  • GTIN

Variable Data:

  • Lot Number
  • Expiration Date
  • Serial Number (optional)*

Implementation Timeline: December 31, 2025

What do pharmacies need to do to determine if they are prepared?

  • Assess scanning equipment - confirming camera-ready barcode scanning equipment is in place to read both linear and 2D barcodes
  • Verify if databases and systems are:
  • Plan for the future: establish a plan to scan and store serialized data in your internal systems

The recommended Adoption Roadmap for Pharmaceutical Barcoding in Canada was approved with the following conditions understood:

  • The Roadmap and related readiness timelines will continue to be assessed through sector and barcoding scorecarding audits. Any recommended adjustments will be brought forward to the GS1 Canada Pharmacy Community Group and Healthcare Board.

Barcoding at all packaging levels:

Barcoding at all packaging levels is different, right from the unit of use to each primary packaging level, it continues right through the secondary box, and continues with case and pallet levels. Similarly, it goes from unit of use to blister cells, continuing to each of the multiple blister cards and right through case or shipper, and pallet level.

Primary and Secondary Packaging:

Each primary packaging has a GTIN before getting into the secondary box packaging.

Guidance Documents

Related Resource Videos

Need Help to Ensure Your Barcodes Scan?

  • Barcode scan verification – to verify barcodes you have created, a report will be generated and shared with you. The report lists all the issues with the barcode or confirms that there are issues.
    For additional information contact info@gs1ca.org

Frequently Asked Questions

Roadmap Basics

The Roadmap was established to advance digital readiness in Canada and align with global timelines for the adoption of GS1 DataMatrix barcodes on pharmaceuticals.

Medication dispensing and patient safety are the strategic imperatives driving this roadmap.

In 2020, the Roadmap was developed and approved by GS1 Canada’s Pharmacy Board representing healthcare providers, pharmacy retailers, hospital pharmacies, group purchasing organizations, distributors and manufacturers across the healthcare community.

Prescription Drugs

  • Manufacturers: The target date was December 31, 2023
  • Distributors: The target date was December 31, 2023
  • Pharmacies: December 31, 2025

Over the Counter (OTCs) and Natural Health Products (NHPs)

  • The transition to a single GS1 DataMatrix barcode for Behind-the-Counter (BTC), Over-the-Counter (OTCs) and Natural Health Products (NHPs) will align with the global timeline for consumer goods which is December 31, 2027.

Medical Devices

  • Timing for medical devices has not been established in Canada yet.

  • Permanently assign a unique GTIN to each packaging level, including unit of use.
  • Affix a GS1 DataMatrix barcode to primary and secondary packaging.
  • During the transition period, you may have two barcodes on a product (e.g., UPC-A & GS1 DataMatrix), you need to ensure both barcodes have the same GTIN encoded in them.
Important Note: The GTIN that is encoded in a GS1 DataMatrix must have 14 digits. For example, a GTIN that has 12 digits (a U.P.C.), has to be padded with two zeros at the beginning to ensure it has 14 digits.
  • Where feasible, affix a GS1 DataMatrix barcode to the Unit of Use level.
  • Affix a GS1-128 barcode at the shipping case level and accept the addition of an optional GS1 DataMatrix (both barcode symbologies must contain the same GTIN) on homogeneous shipping cases.

Distributor and pharmacy systems are expected to have the ability to:

  • Scan GS1 DataMatrix for the primary and secondary packaging and GS1-128 for shipping cases.
  • Store and ingest unique GTINs at each packaging level, including unit of use.
  • Store and ingest the additional information that is encoded in the barcode such as lot# and expiry date.

Note: Distributors re-packaging products should follow guidelines set for manufacturers to assign GTINs to the re-packaged product using the distribution company’s prefix.

The following points were considered when determining timelines:

A three-year window (2021-2023) was established to recognize the varying levels of readiness among manufacturers to identify concerns around the practical feasibility of the proposed timelines.

Currently serialization is optional in Canada. Manufacturers who include serial numbers in barcodes to meet regulatory requirements for other countries are encouraged to also include serial numbers in their barcodes destined for Canada.

The information below is encoded in the GS1 DataMatrix in Canada:

  • GTIN (mandatory)
  • Expiration Date (mandatory)
  • Lot Number (mandatory)
  • Serial Number (optional)

Note: A GS1 DataMatrix requires a 14-digit GTIN, so when encoding a GTIN-12 or a GTIN-13 you must add leading zero(s) to make the GTIN 14-digits e.g.

GS1 DataMatrix encoding a GTIN-13 in a 14-digit format, using AI (01).

The Roadmap aligns with the US FDA’s DSCSA at the saleable unit level, with two exceptions:

  1. Serial numbers in barcodes are mandatory in the US, but optional in Canada.
  2. Canada is requesting GS1 DataMatrix at the primary and secondary packaging levels regardless of whether packaging is saleable unit or not. The US FDA policy is only at the saleable unit level.

The GS1 DataMatrix provides additional information in comparison to the 1D barcode (UPC-A) that is on products currently. Using an app, the consumer can access the information on the web if the brand owner has encoded it in a GS1 DataMatrix.

Regulatory Related

For GTIN assignment, review the GS1 Healthcare GTIN Allocation Rules. You must consult regulatory requirements for Canada and US as well as the GS1 Healthcare GTIN Allocation Rules to determine if you need to assign a new GTIN to your product or can continue using the same GTIN.

Health Canada does not regulate barcoding. The pharmacy community has consistently recommended that Health Canada follow other regulators who have implemented barcoding and/or traceability regulations.

Health Canada has been engaged in many initiatives and meetings directed by the needs of supply chain for clinical and non-clinical purposes. However, the Public Health Agency of Canada has established barcoding guidelines for vaccines, in support of immunization traceability.

For questions about the Health Canada labelling requirements and submission process, contact Health Canada directly.

A term used in the GS1 System of Standards, HRI refers to the GTIN number encoded in the barcode and also visible below, beside or above a barcode. It represents the exact same characters encoded in the barcode.

In the “Good Label and Package Practices Guide for Prescription Drugs” glossary, Health Canada defines readability as “how easy a piece of writing is to read and understand." Health Canada does not use the term “HRI”, and readability refers to the text information Health Canada requires on the package. This information in the GS1 System of Standards is referred to as Non-HRI text.

The image below from GS1 General Specifications shows the difference between Human Readable Information (HRI) and the Non- HRI that Health Canada requires on the package.

The date format you use in the Non-HRI text can be a format that Health Canada accepts.

Implementation

The roadmap recommends assignment of the GTIN to the unit of use level (i.e. the individual pill).

  • This means a manufacturer should assign a unique GTIN to this product hierarchy level, but not necessarily mark it with a barcode.
  • If the pill is within a blister, then it is feasible and recommended affixing a GS1 DataMatrix containing the GTIN and additional information (e.g., expiry date) to the unit of use level.

Refer to the Healthcare GTIN Allocation Rules Standard section 2.1.2 Assignment of GTINs within a trade item hierarchy.

Yes, the zero should be incorporated in the HRI. In the image below the GTIN has 13 digits and the leading zero is incorporated in the HRI.

A unique Global Trade Item Number (GTIN) must be assigned for each packaging hierarchy. If you have not already assigned GTINs to your products, follow the steps below:

  • Obtain your GS1 Company Prefix from GS1 Canada (if you are in Canada).
  • Using your GS1 Company Prefix, you will create and assign GTINs to each packaging hierarchy. Visit the GS1 Canada GTIN page for additional information on how to assign GTINs to your products. We also recommend that you review the GS1 Healthcare GTIN Allocation Rules before starting to assign your GTINs.
  • After a GTIN is created for each packaging level, encode your GTIN, lot and expiry date in the GS1 DataMatrix barcode and affix it on the product.
  • GTINs encoded in GS1 DataMatrix barcodes must have 14 digits. Ensure your GTIN has 14 digits, by padding it with zeros at the beginning.

For information on how to create a GS1 DataMatrix, review the GS1 General Specifications (section 5.6 Two Dimensional Barcodes – GS1 DataMatrix Symbology). If you have further questions, contact info@gs1ca.org.

When the GTIN and additional information such as lot number and expiry date are encoded together, the GTIN should appear before the additional information. In most cases, the predefined length information such as dates should be followed by non-predefined information such as lot numbers (For additional information, refer to page 145 of the GS1 General Specifications.)

Note: The barcode image presented here has been enlarged for visibility and should not be used as a basis for measurement.

You can orientate the HRI either vertically or horizontally. The most common orientation is vertically stacked. You can also rotate the text to be vertical or horizontal.

GS1 Canada’s Barcode Verification Services can validate your HRI. For additional information on GS1 human readable interpretation, refer to section 4.14 of the GS1 General Specifications.

The GS1 system of standards requires printing of both the GS1 barcode and the HRI representing the information encoded within that barcode. As per The Roadmap, you need to encode GTIN, lot number and expiry date in the barcode, with HRI representing this information in a readable format next to the barcode.

The rules for defining and applying HRI are described in Section 4.14 of the GS1 General Specifications.

  • Application identifier 17: USE BY or EXPIRY Date
  • Application identifier 10: BATCH/LOT Number

Review GS1 General Specifications section 3.4.1 and 3.4.7, for additional information on these application identifiers.

The expiry date is the date that determines the limit of consumption or use of a product/coupon. It is often referred to as "use by date" or "maximum durability date”. The structure of the expiry date within the GS1 System of Standards is:

  • Year: the tens and units of the year (e.g., 2003 = 03), which is mandatory.
  • Month: the number of the month (e.g., January = 01), which is mandatory.
  • Day: the number of the day of the relevant month (e.g., second day = 02); if it is not necessary to specify the day, the field must be filled with two zeroes.
Important Note: How the day of the month is expressed for regulated healthcare products will change starting January 1, 2025, when the day of the month will no longer be expressed as two zeroes. From that date, a valid day of the month (e.g., last day of July = 31) must be included. Note: The expiry date can only specify dates ranging from 49 years in the past to 50 years in the future.

Based on The Roadmap, GS1 DataMatrix barcode expectations are:

  1. On primary packaging (e.g., a bottle)
  2. On secondary packaging (e.g., box containing one or more bottle)

You need a GS1 DataMatrix, which is the only version of a Data Matrix that supports GS1 system data structures, including GS1 Application Identifiers and Function 1 Symbol Character (FNC1). If a non GS1 DataMatrix is used, GS1 Application Identifiers may not be readable by scanners.

The Roadmap, which was approved by the GS1 Pharmacy Board in 2020, supports a transition period when two barcodes (linear and GS1 DataMatrix) will be on the product. Except for products that don’t currently have a barcode or where there is small usable space, only a GS1 DataMatrix should be used. This applies to newly launched products as well. It is expected that the transition period will be finished by December 31, 2025.

It is possible to incorporate GTIN, lot and expiry within a very small space using GS1 DataMatrix.

It is recommended that manufacturers work with their printing and packaging designers to examine options. If you cannot accommodate barcodes on the primary packaging, then the following interim approach is recommended:

  • For prescription drugs - use the GS1 DataMatrix barcode

GS1 Canada offers a Barcode Scan Verification Service to its subscribers. Barcode Scan Verification tests your printed barcode images to ensure they can be scanned by scanners. By identifying problems with barcodes before wide-scale production of packaging begins, brand owners can avoid products being withdrawn or packaging redesigned and reprinted due to malfunctioning barcodes and scanning issues.

A GS1 DataMatrix requires a 14-digit GTIN.

  • If you are using an existing GTIN-12 (U.P.C.) or 13-digit GTIN, you will need to add leading zeros to create the GTIN 14-digit. For the GTIN-12, you need to add two leading zeros and for the GTIN-13, one leading zero.

Example: A UPC-A barcode symbol and a GS1 DataMatrix barcode symbol. Both barcodes have the same GTIN but the GS1 DataMatrix encodes the GTIN as 14 digits, also it has a production date, a lot number and a serial number.

For case and pallet level packaging, the GS1-128 continues to be the mandatory barcode at the shipping level. However, a GS1 DataMatrix can also be assigned optionally only on homogenous cases.

Preferred barcode placement is on the lower right quadrant of the back, respecting the proper Quiet Zone areas around the barcode and the edge rule.

Bottom marking of the trade item with the barcode continues to be acceptable, except for large, heavy or bulky trade items. However, back (side) marking is preferred. Sections 6.3.3.1 and 6.3.3.5 of GS1 General Specifications provide more detail.

The GS1 system of standards requires the use of symbology identifiers. The symbology identifier is the first three characters transmitted to the scanner.

  1. GS1 DataMatrix uses the symbology identifier of ]d2, indicating to the scanner that GS1 Application Identifier (AI) data could be encoded in the barcode.
  2. Non-GS1 Data Matrix uses the symbology identifier of ]d1. If you use this barcode, you cannot encode the additional information in the barcode using GS1 Application Identifiers.

For additional information refer to: GS1 General Specifications (section 5.6.3.3 - Application Identifiers, section 5.1.3 - Symbology Identifiers and section 2.2.2 - GS1 DataMatrix Guideline)

If the barcode goes directly on the syringe cylinder, it will need to use the GS1 DataMatrix in the smallest dimension that is allowed by the GS1 General Specifications. Alternatively, if the syringe comes with packaging there will be more flexibility on barcode size depending on the available space on the package.

In North America the most common GTIN used is GTIN-12. However, if products are shipped from other parts of the world, they could have a GTIN-13. Both GTIN-12 and GTIN-13 must be encoded in the GS1 DataMatrix as a 14-digit GTIN. This means that the GTIN-12 will need to have two leading zeros and the GTIN-13 will need to have one leading zero.

GTIN-14 can be used is used for shipping units and units of use in healthcare.

You should verify whether your organization's current scanning system is equipped to scan GS1 DataMatrix barcodes, which require image-based scanning capability. Usually, a simple reconfiguration of existing image-based scanners is sufficient to enable successful scanning.

However, if you currently use a laser scanner, an upgrade is necessary to enable scanning of GS1 DataMatrix barcodes. If the image-based scanners that you currently have lack the ability to process GS1 DataMatrix, the scanners could potentially be enhanced with a simple software update. For specific information on how to enable your scanners please consult your scanning equipment provider.

No. The mandatory requirement of The Roadmap is to encode GTIN, lot number and expiry date. It is possible to incorporate GTIN, lot and expiry within a very small space using GS1 DataMatrix. It is recommended that manufacturers work with their systems solution providers, including print and packaging designers, to examine options. If you cannot accommodate barcodes at the primary or secondary packaging levels, then the following interim approach is recommended:

  • For prescription drugs - utilize the GS1 DataMatrix barcode

A URL cannot be encoded directly in a GS1 DataMatrix. To link a GS1 DataMatrix to a URL, you need to use an app and a resolver technology. The resolver technology scans the existing barcode and redirects to the desired URL. For more information on using apps and GS1 Digital Link (GS1 DL) technology, please refer to this position paper.

Additional Resources


For additional information contact info@gs1ca.org, healthcare@gs1ca.org, or visit the GS1 Canada Standards webpage.