Substance Law provides legal and regulatory label review services for drug products sold in Canada. We assist manufacturers, importers, and brand owners in ensuring their drug labels comply with Canadian requirements before entering the market.
Drug labelling in Canada is governed by the Food and Drugs Act and the Food and Drug Regulations, and is closely tied to each product’s drug identification number (DIN) and approved product licence. Non-compliant labels can result in enforcement action, product recalls, import refusals, or delays in market entry.
We review drug labels for compliance with applicable laws and provide practical guidance to reduce regulatory risk. For food, natural health product, or general consumer packaged goods labelling, see our food label review services or our full label review practice overview.
Drug Label Review and Regulatory Compliance
Drug products are subject to strict labelling and authorization requirements, and a label cannot simply be drafted — it must align with what Health Canada has actually authorized for that product.
We assist with:
- drug facts table and required information
- product classification (drug vs. NHP vs. cosmetic)
- compliance with approved indications
- warnings, directions for use, and claims
- alignment with product licences and submissions
Drug labelling must align with regulatory approvals and product classification — a mismatch between label claims and the approved licence is one of the most common sources of Health Canada enforcement action.
Product Classification: Drug, NHP, or Cosmetic?
Many enforcement issues start with a misclassified product. Whether a product is regulated as a drug, a natural health product, or a cosmetic depends on its ingredients, formulation, and the claims made about it — not simply how it’s marketed or packaged.
We help determine the correct classification before labelling is finalized, since the wrong classification can mean the wrong authorization pathway, the wrong label requirements, and the wrong claims regime entirely.
Claims and Marketing Review for Drug Products
Claims on drug labels and in related marketing materials are closely regulated in Canada.
We assess:
- health and therapeutic claims
- alignment between marketing claims and approved indications
- comparative and performance claims
- implied claims and marketing language
Improper claims can trigger enforcement, even if other label elements are compliant and the underlying product licence is in good standing.
Bilingual and Disclosure Requirements
Drug labels sold in Canada must meet mandatory bilingual and disclosure requirements.
We review:
- English and French translation requirements
- placement and prominence of required information
- ingredient and warning disclosures
- formatting and placement requirements
Failure to comply with bilingual or disclosure requirements can result in enforcement action or product rejection.
Import and Market Entry Label Compliance
Imported drug products must meet Canadian labelling standards before entering the market.
We assist with:
- reviewing foreign drug labels for Canadian compliance
- adapting labels for Canadian requirements
- identifying gaps prior to import
- reducing risk of border or inspection issues
Pre-market label review helps avoid costly delays and enforcement action.
Why Work With Substance Law for Drug Label Reviews
- experience with regulated drug products and compliance frameworks
- understanding of Health Canada expectations and enforcement patterns
- practical, business-focused advice
- support for Canadian and international drug companies
We provide legal guidance to help drug businesses bring compliant products to market.
Work With a Drug Label Compliance Lawyer in Canada
If you are launching or selling a drug product in Canada, label compliance is a critical step in regulatory approval and market entry.
Substance Law assists drug businesses with label reviews and compliance strategy.
Contact Substance Law to discuss your drug label review.
Frequently Asked Questions
Does every drug product need a label review before it’s sold in Canada?
Not every product requires a formal legal review, but any drug label should be checked against the Food and Drugs Act and Food and Drug Regulations, and against the product’s approved licence, before market entry — mismatches between labels and approvals are a common cause of enforcement action.
What’s the difference between a drug label review and a product licence application?
They’re related but separate. A product licence or DIN authorizes your product for sale in Canada with specific approved indications; a label review checks that your product’s actual label and packaging comply with labelling law and match what was approved.
How do I know if my product is a drug, an NHP, or a cosmetic?
Classification depends on the product’s ingredients, formulation, and the claims made about it, not on how it’s marketed. Misclassification can lead to using the wrong authorization pathway and the wrong labelling rules, so it’s worth confirming before labels are finalized.
Do imported drug products need Canadian-compliant labels before they arrive?
Yes. Foreign labels generally need to be reviewed and, where necessary, adapted to meet Canadian bilingual and disclosure requirements before the product can be sold here.
What happens if a drug label doesn’t comply with Canadian requirements?
Non-compliant drug labels can lead to Health Canada enforcement action, mandatory recalls, import refusals at the border, or delays in getting the product to market.
