Health Canada Guidance on Labelling of Pharmaceutical Drugs for Human Use

1. Purpose

The guidance document assists industry and healthcare professionals in complying with the Food and Drugs Act, Food and Drug Regulations, Controlled Drugs and Substances Act, and related regulations. It ensures labelling supports safe and effective use of pharmaceutical drugs by healthcare professionals, patients, and consumers. It interprets labelling requirements based on precedents and reflects amendments, including the repeal of Schedule F (replaced by Prescription Drug List) effective December 19, 2013, and plain language labelling amendments effective June 13, 2015, for prescription products and those administered or obtained through a health professional. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/labelling-pharmaceutical-drugs-human-use-2014-guidance-document.html

2. Scope and Application

Applicable to pharmaceutical drugs for human use, excluding disinfectants, veterinary drugs, clinical trial drugs, natural health products under Natural Health Products Regulations, and radiopharmaceuticals/biological drugs in Schedules C and D of the Act. It includes excerpts from relevant Acts and Regulations, term definitions, and interpretations of labelling requirements. Examples are illustrative and do not represent actual products. Read in conjunction with other Health Canada guidance documents. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/labelling-pharmaceutical-drugs-human-use-2014-guidance-document.html

3. General Labelling Requirements

Governed by sections 3, 9, and 10 of the Act and Parts A, C, D, G, J of the Regulations.

• Section 9 (Act): Prohibits false, misleading, or deceptive labelling.
• Section 3 (Act): Prohibits advertising/selling drugs as treatments for Schedule A diseases, with exceptions.
• Placement of Information:
  • Principal Display Panel (Main Panel): Must show brand/proper/common name, standard, sterility notation (if required), scheduling symbol (if applicable), and DIN.
  • Any Panel: Must show manufacturer/sponsor details, lot number, expiration date, directions for use, medicinal ingredients, net contents, preservatives (for certain preparations).
  • For prescription products (as of June 13, 2015): Include contact information for reporting harms and a statement allowing harm reports.
• Official Languages: Bilingual (English/French) for non-prescription drugs in open self-selection areas; otherwise, customer's choice. Additional languages acceptable if not obscuring official languages.
• Legibility: Clearly displayed, discernible under customary conditions; plain language required (as of June 13, 2015); recommend 10-point font for consumer info, Sans Serif type.
• Abbreviations: Avoid for names; allowed for units/routes if common and explained; prefer "mcg" over "μg".
• Reference to Act/Regulations: No direct/indirect references (e.g., "Health Canada approved") unless required.
• Voluntary Industry Guidelines: Acceptable if not conflicting with regulations (see Appendix C).
• Schedule A Claims: Prohibited for treatments/preventatives/cures; exceptions for directions, precautions, or authorized non-prescription preventatives.
• Novel Label Formats: Acceptable if accessible without destroying integrity, consumers alerted, and complies with regulations; critical info visible without manipulation.
• Bar Codes: Allowed if not obscuring required info or altering authorization.
• Final Labels: Must match marketed version; submit bilingual mock-ups at submission for prescription products (as of June 13, 2015); final labels not required post-market for these. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/labelling-pharmaceutical-drugs-human-use-2014-guidance-document.html

4. Label Information

• Definition of Label: Includes affixed labels, inserts, monographs, fact sheets, patient info leaflets.
• Labelling vs. Other Information: Labelling includes patient-directed materials improving compliance/safety, submitted for review; excludes general disease info, advertising, independent scientific summaries.
• Inner Label: Affixed to immediate container.
• Outer Label: Affixed to packaging; all info if single label.
• Main Panel:
  • Brand Name: Approved name, consistent, uninterrupted; changes require submission.
  • Proper/Common Name: Required; proper name from Regulations/Schedule B; common for non-proper (e.g., INN); include solvated forms if applicable.
  • Standard of Manufacture: Prescribed (CSD), pharmacopoeial (Schedule B), manufacturer's (house), or professed; declare near name; update as needed.
  • Sterility: "Sterile (stérile)" if required.
  • Scheduling Symbols: For Prescription Drug List/schedules; most stringent applies.
  • DIN: Required for dosage forms.
• Any Panel:
  • Manufacturer/sponsor details (include importer/distributor if non-Canadian); contact info for harms (prescription, as of 2015).
  • Lot number, expiration date (recommend specific formats, e.g., YYYYMMDD).
  • Adequate directions: Indications, dosage, route, warnings, storage.
  • Medicinal ingredients: Quantities by proper/common name; specific declarations by form (e.g., mg/dosage form); avoid trailing zeroes; details for dilutions, combinations, patches, implants.
  • Non-medicinal ingredients: List alphabetically or by predominance; precede with "nonmedicinal (inactive)"; ± for variables; required on outer label for non-prescription (as of 2012); optional for prescription.
  • Net contents: On outer; metric primary.
  • Preservatives: Identify presence/absence.
• Special Packaging:
  • Co-packaged: Comply per product; consult for claims/safety.
  • Small Containers: Abbreviated inner if too small; outer complies fully.
  • Special Containers: Multi/single-dose packs; minimal info (name, potency, lot/expiry).
  • Security Packaging: Attention-drawing for public-available products.
  • Pressurized Containers: Warnings/symbols for flammability.
• Technical Information and Language: Grade 8 level, clear, headed/bulleted; balance detail.
• Professional Samples: Label like regular; include all info.
• International Information: Allowed if not confusing, consistent with Canadian authorization. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/labelling-pharmaceutical-drugs-human-use-2014-guidance-document.html

5. Claims and Text Content

• Prohibited if false/misleading under section 9(1) of the Act.
• Misrepresentation of Classification: Clearly indicate as drug.
• Absence of Ingredients: Acceptable if true (e.g., salt-free); time-limited for removed ingredients; specify sweeteners if claiming sugar-free.
• Absence of Side Effects: Supported by evidence (clinical trials, power 80-90%); equal prominence for presence; prior approval needed.
• Side Effects and Placebo Comparisons: Avoid; simplify to list frequent effects.
• Look-alike, Sound-alike Names: Assess risk; new requirements for submissions (as of 2015).
• Comparisons: Avoid therapeutic; encourage positive merits; implied (e.g., better) misleading unless explained; non-therapeutic per policy.
• High/Low: Unacceptable without standard.
• Endorsements/Testimonials: Prohibited if misleading.
• Conditionally Positive Terms: Limited (e.g., new/improved for one year).
• Potentially Misleading Terms: Avoid superlatives (e.g., maximum strength, natural).
• Negative Statements: Avoid fear-inducing; e.g., non-toxic if inappropriate.
• Product Cross-promotion: Prohibited.
• Imagery/Symbols: Not misleading. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/labelling-pharmaceutical-drugs-human-use-2014-guidance-document.html

6. Additional Considerations for Specific Product Types

• New Drugs: Comply with Division 8 requirements.
• Consumer Non-prescription: Standards/monographs; directions (indications, dosage, routes, warnings).
• Narcotic-controlled Non-prescription: Per regulations.
• Prescribed/Parenteral: Dosage, package insert, details for parenterals (names, ingredients, directions); prescribing info.
• Notice of Compliance with Conditions: Specific labelling.
• Professional Use: Appropriate info. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/labelling-pharmaceutical-drugs-human-use-2014-guidance-document.html

7. Appendices

• Appendix A: Definitions: Terms like inner/outer label, principal display panel, standard.
• Appendix B: Applicable Health Canada Guidance Documents and Policies: E.g., Product Monograph, Post-NOC Changes, Non-medicinal Ingredients Nomenclature.
• Appendix C: Third-Party Guidance Documents: E.g., abbreviations, bar codes, plain language. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/labelling-pharmaceutical-drugs-human-use-2014-guidance-document.html