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GS1 DataMatrix Barcodes on Pharmaceuticals in Canada

Roadmap to the Implementation of GS1 DataMatrix Barcodes on Pharmaceuticals in Canada

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 at all packaging levels. 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:
Manufacturers - December 31, 2021 to December 31, 2023
Distributors - December 31, 2023
Pharmacies - December 31, 2025

*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:
    • Allocated according to the GS1 Healthcare GTIN Allocation Rules
    • Properly formatted so GS1 DataMatrix is created using the GTIN-12 or GTIN-13 in 14-digit format (using leading zero(s))

* 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:
    • Properly configured so the 14-digit GTIN can be stored in a 14-character data field
    • Able to ingest/store lot number and expiry date (to enable lot-based recalls and stock rotation)
  • 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:
    • Properly configured so the 14-digit GTIN can be stored in a 14-character data field
    • Capable of ingesting/storing lot number and expiry date (key to lot-based recalls and stock rotation)
  • 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 Working Group and Healthcare Pharmacy 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

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

Patient safety, best practices in dispensing to the patient record, fighting counterfeiting and improvements to supply chain traceability capabilities are the strategic imperatives driving this movement.
The Roadmap was developed and approved by GS1 Canada's Pharmacy Board representing healthcare providers, retailers, hospitals, group purchasing organizations, distributors, and manufacturers across the healthcare community.


The roadmap was developed and approved by GS1 Canada's Pharmacy Board, representing healthcare providers, retailers, hospitals, Group Purchasing Organizations (GPOs), distributors and manufacturers across the healthcare community.

The timelines for implementation for prescription drugs are as follows:

December 31 2023 - Manufacturers,
December 31 2025 - Distributors,
December 31 2025 - Pharmacies,

Over-the-Counter (OTCs) and Natural Health Products (NHPs) will align with the global movement for consumer goods which has the goal of retail POS scanners being capable of scanning and processing 2D barcodes by the end of 2027. In Canada the industry does not have an established date for these product categories. Priority of adoption for these products can be given to OTCs and NHPs used at the point of patient care for traceability.

Medical devices sold at the retail level will also align with the Global 2D Transition program movement for consumer goods.

  • Affix a GS1 DataMatrix barcode to primary and secondary packaging.
  • If you haven't already, permanently assign a unique GTIN to each packaging level. If you have already assigned GTINs, you must use the same GTIN in your GS1 DataMatrix and other barcodes you have on your products and its packaging.
  • Assign and, where feasible, mark a GTIN to the unit-of-use level, if you have not already done so. Affix a GS1-128 at the case level and accept the addition of an optional GS1 DataMatrix.
    Note: Both barcode symbologies must contain the same GTIN
  • Barcodes could include static and variable data.

The systems for distributors and pharmacies are expected to have the ability to scan, store and integrate:

  • GS1 DataMatrix for the primary and secondary packaging
  • Unique GTINs at each packaging level
  • GTINs at the unit-of-use level, if marked on the unit-of-use
  • GS1-128 at the case level

Barcodes include static and variable data such as:

  • GTIN (Static)
  • Expiration Date (variable)
  • Lot Number (variable)
  • Serial Number (variable) (optional)

The following points were considered when determining timelines:

  • Existing regulations in other regions such as the United States, the European Union and India
  • The statement made by ISMP/CPSI supporting barcoding
  • The statement made by the Public Health Agency of Canada supporting barcoding for vaccines

The three-year window was established to recognize the varying levels of readiness among manufacturers.

Currently serialization is optional in the pharmacy roadmap.

Do I need serial number if I only sell in stores or online?

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.

This Pharmaceutical Barcoding Roadmap aligns with The Food and Drug Administration's (FDA) DSCSA at the saleable unit level, with two exceptions:

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

Regulated pharmaceutical product in the US require a specific GTIN format. Manufacturers should contact GS1 US to obtain the GTIN as the regulatory number.

In addition, non-regulated pharmacy products sold in Canada and the US have different requirements.
For example, the language and regulatory requirements are different in each country. As a result, a separate GTIN needs to be assigned to the product for each country.

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 at the needs of supply chain for clinical and non-clinical purposes. The Public Health Agency of Canada however 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, Labelling Division directly.

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 specific GTIN for this hierarchy level, but not necessarily mark it with a barcode.
  • If the pill was within a blister, then it is possible to mark the GTIN to the unit of use level.


If a separate GTIN is created as GTIN B (each or Consumer unit level), the GTIN for the case will be created based on GTIN B. The examples below have assumed the GTIN for the bottle and the box is the same (GTIN A).




Additional Information on GTIN assignments

Unit of use: Create a GTIN-14 that is based on the each level (GTIN A) or you can assign a new GTIN-12 or GTIN-13 to this level based on the company prefix assign to your organization.

Case and Pallet:
  • The GTIN-14 is created based on the GTIN of the each level (GTIN A). If the Box is assigned a new GTIN (GTIN B), then the case and pallet GTINs should be created based on the box GTIN (GTIN B)
  • GTIN-14 is created based on a homogenous child GTIN (in this example GTIN A), meaning the case and pallet contain only a single GTIN. If the case and pallet contain more than one GTIN (mixed products), then a new GTIN-12 or GTIN-13 has to be assigned.
Note: When encoding a GTIN-12 or a GTIN-13 in the GS1 DataMatrix, you need to add leading zero(s) to make the GTIN a 14-digit GTIN. GS1 DataMatrix requires a 14-digit GTIN.

A unique Global Trade Item Number (GTIN) is assigned to 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.
  • After a GTIN is created for each packaging level, encode your GTIN, lot and expiry date in a GS1 barcode and affix it on the product.

For more information about the GTIN Management Standard, review the Healthcare GTIN Allocation Rules. If you have further questions, contact info@gs1ca.org or 1.800.567.7084.

When a predefined length GS1 key and attributes are encoded together, the GTIN should appear before the attributes. In most cases, the predefined length element strings should be followed by non-predefined element strings. (For additional information, refer to page 145 of the GS1 General Specifications.)

You can orient the human readable interpretation either vertically or horizontally, however, the most common orientation is vertically stacked. You can also rotate the text to be vertical or horizontal.

GS1 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 requires printing both the GS1 barcode and the HRI that represents all the information encoded within that GS1 barcode.

As per the Roadmap, you need to the encode GTIN, lot and expiry date in the barcode. HRI represents this information in readable format next to the barcode.

The rules for defining and applying HRI are described in Section 4.15 of the GS1 General Specifications.

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

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

  • The expiry date is encoded in a barcode as YYMMDD.
  • It can appear as DD Mon YYYY to make it easier for the reader.
    For example: 141120 vs. 20 Nov 2014.
  • The rules are described in GS1 General Specifications, Section 4.15.

You need a GS1 DataMatrix.

GS1 DataMatrix is the only version of a Data Matrix barcode 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.

Barcode expectations for packaging levels based on the roadmap are:

  1. On primary packaging (e.g., a bottle): a GS1 DataMatrix
  2. On secondary packaging (e.g., box containing one or more bottles): a GS1 DataMatrix

Both linear and GS1 DataMatrix are recommended to support the transition period (now until December 31, 2025). This allows distributors and pharmacies to prepare for GS1 DataMatrix scanning capabilities at the saleable unit.

Primary packaging, when not the saleable unit, requires only one GS1 DataMatrix barcode.

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

  • The x-dimension of GS1 DataMatrix is 0.750 mm. The height of the barcode is determined by the x-dimension and data that is encoded.

It is recommended that manufacturers work with their print and packaging designers to examine options. If you cannot accommodate barcodes at the saleable unit, then the following interim approach is recommended:

  • For prescription drugs - utilize the GS1 DataMatrix barcode
  • For OTC and NHPs - utilize the linear barcode
    The x-dimension refers to the height and width measurement of one cell (square element) in a GS1 DataMatrix barcode.

GS1 Canada offers a Barcode Scan Verification Service to its subscribers. Barcode Scan Verification tests your printed barcode images to ensure that they can be scanned the first time, and every time.

By identifying any problems with barcodes before wide-scale production of packaging begins, brand owners can avoid the products being withdrawn, packaging redesign and reprints due to malfunctioning barcodes.

A GS1 DataMatrix requires a 14-digit GTIN.

  • If you are using an existing GTIN-12 (UPC) 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 has a production date, a lot number and a serial number.

For case and pallet level packaging, GS1-128 continues to be the mandatory barcode, however, a GS1 DataMatrix can also be assigned optionally (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.

Clarification of the differences between the ]d1 format and ]d2 format

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

GS1 DataMatrix uses the symbology identifier of ]d2, which indicates to the scanner that GS1 Application Identifier (AI) data could be encoded in the barcode.

Note 1: GS1 DataMatrix symbology identifier is ]d2 and not ]d1.
Note 2: ]d1 is used in regular Data Matrix, if you use this barcode, you cannot use GS1 Application Identifiers with it.

For additional information refer to:
GS1 General Specifications; section 5.6.3.3 - application identifiers and section 5.1.3 - symbology identifiers and GS1 DataMatrix Guideline; section 2.2.1