Comply with Health Canada: Canadian Pharmaceutical Labeling Rules

Comply with Health Canada: Canadian Pharmaceutical Labeling Rules

BY: NICK RECHT / DATE: 27/03/2025 / TOPICS: תרופות, קנאביס, REGULATORY COMPLIANCE, ENTERPRISE LABEL MANAGEMENT, LABEL TRACEABILITY

Pharmaceutical labeling plays a key role in ensuring patient safety, proper medication use, and regulatory compliance. Health Canada is part of the Canadian federal government responsible for overseeing pharmaceutical drug labeling regulations, ensuring all pharmaceutical products provide accurate and accessible information.

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While Health Canada shares some similarities with the US Food and Drug Administration (FDA), there are differences in the regulatory frameworks. For example, Health Canada enforces stricter bilingual labeling requirements and follows unique guidelines for natural health products. Adhering to these regulations is crucial for protecting consumers and ensuring pharmaceutical companies can legally distribute their products in Canada’s healthcare market. Failure to comply can result in recalls, fines, or even legal action, creating a greater need for businesses to stay informed and up to date with evolving regulations.

What Canadian authorities govern labeling regulations?

Health Canada is the primary authority responsible for the national health policy, including the review and approval of drug applications and the regulations of pharmaceutical labeling. Health Canada oversees other federal-health related agencies such as the Canadian Food Inspection Agency (CFIA) and the Public Health Agency of Canada.

Pharmaceutical organizations labeling drugs for human use must comply with specific regulations outlined in Section 3, 9, and 10 of the Food and Drug Regulations Act, the Controlled Drugs and Substances Act, and related regulations. These include controls for narcotics, benzodiazepines, and other targeted substances. For more details visit Health Canada’s website.

Food and Drug Regulations Act

The labeling of drug products is governed by the sections of the Act below.

The Food and Drug Regulations Act (FDR) aims to protect the health and safety of Canadian residents by regulating the sale of food and drug products. These regulations establish specific requirements for labeling, packaging, manufacturing, importing, and distribution. By setting these standards, the FDR helps guarantee all food and drug products remain safe throughout the supply chain before they reach the hands of the consumer.

Section 3

Section 3 states “no person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.” And “no person shall sell any food, drug, cosmetic or device that is represented by label, or that the person advertises to the public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.”

Section 9

Section 9, quoted directly from Health Canada states, “no person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.” And “a drug that is not labeled or packaged as required by, or is labeled or packaged contrary to, the regulations shall be deemed to be labeled or packaged contrary to subsection.”

Section 10

This section refers to the standard by which a drug product is manufactured and represented. The standards can be applied to a drug product or to an ingredient.

You can find more information about each section of the Food and Drug Regulations Act on Health Canada’s website.

Controlled Drugs and Substances Act

The Controlled Drugs and Substances Act is a law that abides by the control of certain drugs, their precursors and other substances. It regulates manufacturers, imports, and distribution of specific substances into one of five schedules. The placement is based on the substance’s medical use, potential for abuse, and safety or dependence liability.

Plain Language Labeling Initiative

Companies producing and selling products for non-prescription drug labels must make sure labels comply and meet the Plain Language Labeling (PLL) initiative, including a requirement for a drug facts table on the outer label. There are also formatting requirements to follow such as common headings, defined fonts and sizes, and using active voice. The formatting helps consumers find information easily, increases legibility, and reduces confusion.

The purpose of the PLL initiative is to reduce health risks and make labels easier to understand for consumers along with letting them know the drug has passed its review and follows the Canadian law.

Labeling requirements for Canadian pharmaceutical labeling

Now that you understand what regulations Canadian pharmaceutical companies must comply with, it's important to understand how to comply with these labeling regulations.

Bilingual Labeling

To ensure equal access for all, Canadian companies that sell food, cosmetics, and medical devices must meet the bilingual labeling requirement by ensuring both the inner and outer labels are in French and English if the drug is for sale without a prescription in an open self-selection area.

Per Health Canada, an "open self-selection area" is a retail area where a drug product is freely available for selection and purchase by the public. As a result, prescription drugs, available in hospitals and clinics only, or drug products intended for professional use only do not require bilingual labelling. The manufacturer or sponsor can label these drug products in the customer's choice of language.

Once bilingual labeling is in place, pharmaceutical companies must also adhere to several other common labeling rules.

Common labeling rules to be included on the inner and outer label:

1. Product identification/name: Generally, the proper or common names of the drug product and any ingredient in the drug product should not be abbreviated.
2. Canadian drug facts table: Can appear as one bilingual table or two unilingual tables, respects PLL regulations, and must include:
   • Active ingredients (medicinal) and inactive ingredients (no medical benefit)
   • Purpose: What the medicine treats and what each ingredient does. For example, cough and cold products might include a decongestant and cough reliever.
   • Uses: The intended benefit of the product
   • Warnings: Information about potential risks, allergies, medical conditions, etc.
   • Directions on how to use the product safely
   • Other information such as storage and disposal
   • Company contact information, including email address, website, or phone number
3. Expiration date: Expiration dates must be included on both inner and outer labels and shown using non-decorative font in minimum size of 6 points (1/12 of an inch). Use one of the acceptable formats below:
   • EXP 2020-JA-11
   • EXP 11-JA-2020
   • EXP 2020-JA
   • EXP JA-2020
   • EXP 2020-01
   • EXP 01-2020
4. Barcodes: Barcodes are an important part of the label and can be used for appropriate purposes (retail inventory, tracking, confirmation of identity, or potency) provided that:
   • All regulatory requirements concerning the label have been met and the barcode information does not change the terms of market authorization for the product
   • The barcode does not obscure or displace the required and approved information on the label, especially on small product labels
5. Dosage instructions & admin, potency: Instructions on how much of the medicine can be taken and the intensity of effect produced for each dose.
6. Drug identification number (DIN): A number generated by a computer that identifies characteristics of a drug product marketed in Canada.
7. Manufacturer/sponsor: States the manufacturer of the drug.
8. Indication: The approved medical condition, disease, or state for which a drug can be safely used.
9. Class or purpose: The category or intended use of the drug.
10. Controlled substances: A drug or chemical where the use is regulated by the government.

Labeling requirements for prescription drugs

Prescription drugs must use the abbreviation/symbol “Pr” and the symbol should be visible on the left quarter of the inner and outer labels.

Labeling requirements for over-the-counter drugs that meet PLL

Over-the-counter (OTC) drugs and prescription medications have different labeling requirements due to the PLL initiative.

Labels on over-the-counter drugs (non-prescription) can be confusing to understand, so to help any confusion, Health Canada introduced the following requirements in 2021, in accordance with the PLL initiative.

• OTC labels must include a DIN
• OTC labels must include a drug facts label so products can be sold in Canadian stores and online

The DIN is an 8-digit computer generated number assigned by Health Canada to a drug product prior to being marketed in Canada. The DIN must appear on any label of prescription and OTC drugs that have been evaluated and approved for sale.

Now that you understand specific label requirements for pharmaceutical labels, let’s get into the barcode software features that can help make labeling easier.

Labeling software features that help you comply

CODESOFT RFID barcode label software is an advanced solution with an intelligent user interface that helps you achieve your labeling goals. CODESOFT can help your pharmaceutical company comply with labeling regulations with:

• Helpful wizards to initiate easy label creation
• Correct formatting and styles by using serialization, variable counters, and barcodes that meet regulatory compliance such as GS1 barcodes

Download a free 30-day trial of CODESOFT label design software with free access to customer support.

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TEKLYNX print automation solution, SENTINEL, has a feature for language support and Kallik phrase management for multi-lingual copy. Learn more about Kallik and SENTINEL.

LABEL ARCHIVE label security and traceability software helps secure your labeling processes and:

• Mitigates errors with user groups, permissions, and automatic data entry—integrating with an ERP (Enterprise Resource Planning) and other systems to generate lot number, serial number, expiration date, and other data needed to meet regulatory requirements
• Centralizes control for traceability and visibility—capturing the who, what, where, and when of your label printing operations in one database for complete audit trails and detailed reporting
• Enables automatic version control to access older versions of labels
• Initiates a label audit trail to reduce risk of labeling errors
• Enables electronic signatures and automated label tracking

Request a free enterprise demo of LABEL ARCHIVE to see how you can secure your labeling.

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Future Canadian labeling requirements to look out for

Regulations are ever-changing and as of this post, Unique Device Identification (UDI) is not a rule Canadian companies must comply with. However, Health Canada has been discussing implementing UDI labeling for medical devices and pharmaceutical companies but have not yet progressed this decision. It’s important to be aware of changes in labeling, so be sure to check Health Canada’s website for updates.

On March 7, 2025, Health Canada launched a consultation on a proposed regulatory framework for health products containing cannabidiol (CBD) that would enable access without a prescription. This represents a key development in the evolving regulation of CBD products, which are currently overseen under the Cannabis Act. If adopted, the new approach would align the regulation of CBD-containing products like other non-prescription health products, potentially easing regulatory requirements for industry stakeholders while upholding stringent standards for safety, efficacy, and quality.

Complying with Health Canada and its pharmaceutical labeling regulations is key to ensuring patient safety and proper medication use, ultimately reducing product recalls and fines.

If you are ready to get started, TEKLYNX can help. Get in touch with a labeling expert today to learn how to achieve accurate Canadian pharmaceutical labels.

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