Labelling Requirements Checklist
Health Canada has amended the Natural Health Products Regulations. For more information and to access the supporting Labelling of Natural Health Products guidance document, visit What's new: Natural and non-prescription health products.
April 2011
Applicants are responsible for ensuring that the label complies with the Labelling and Packaging requirements set out in Part 5 of the Natural Health Products Regulations (NHPR), specifically Sections 86 – 95 and 97, if applicable. As per section 86(1) no person shall sell a Natural Health Product unless it is packaged and labelled in accordance with these Regulations.
The following checklist is a resource tool to be used for label generation by applicants intending to submit a Product Licence Application (PLA) for a natural health product (NHP).
Applicants are encouraged to carefully review their label prior to submission to ensure that all necessary information has been provided.
Please refer to the Labelling of Natural Health Products guidance document for further interpretation of the Labelling and Packaging requirements:
Key Point: When preparing a label for a product licence application
* The information provided on the label must be consistent with the information on the Product Licence Application form.
* If any advertising is to appear on the label, it must not contravene Section 9 of the Food and Drugs Act.
The NNHPD does not review advertising claims on labels. Applicants are responsible for ensuring that any advertising claims on the labels of their products do not contravene Section 9 of the Food and Drugs Act. Advertising claims must be consistent with the Consumer Advertising Guidelines for Marketed Health Products and the Guidelines for Cosmetic Advertising and Labelling.
You may also refer to the Labelling Checklist in Annex C of the Labelling of Natural Health Products guidance document.
Additional resources for product licence applicants:
- Labelling of Natural Health Products guidance document
- Natural Health Products Management of Applications Policy
- What's new: Natural and non-prescription health products
- Natural Health Products Regulations(NHPR)
- Food and Drugs Act
- Food and Drug Regulations
- Consumer Advertising Guidelines for Marketed Health Products
- Guidelines for Cosmetic Advertising and Labelling Claims
| Labelling Requirement | Outer label (NHP with inner/outer) |
Inner label (NHP with inner/outer) |
Only one label | Exempted product |
|---|---|---|---|---|
| 1.0 Principle display panel: | ||||
| 1.1 Primary Brand Name | X | X | X | X |
| 1.2 Product Number (NPN or DIN-HM pre-fix) | X | X | X | X |
| 1.3 Dosage Form | X | X | X | X |
| 1.4 If the product is sterile, the words "sterile" and « stérile » | X | X | X | X |
| 1.5 Net amount in the immediate container in terms of weight, measure or number | X | X | X | X |
| 2.0 On any panel: | ||||
| 2.1 Name and contact information of the product licence holder or importer | X | X | X | X |
| 2.2 Proper name of each medicinal ingredient, or common name if the proper name is a chemical name | X | X | X | X |
| 2.3 Quantity of each medicinal ingredient per dosage unit (including potency, extract ratio and Quantity Crude Equivalent, if applicable) associated with proper name | X | X | X | X |
| 2.4 Description of source material of each medicinal ingredient | X | - | X | Outermost label |
| 2.5 Recommended use or purpose | X | X | X | X |
| 2.6 Recommended route of administration | X | X | X | X |
| 2.7 Recommended dose (including subpopulation, amount, frequency, and directions of use, if any) | X | X | X | X |
| 2.8 Recommended duration of use, if any | X | X | X | X |
| 2.9 Risk information and warnings | X | X | X | X |
| 2.9.1 Allergen source, gluten and gluten source or added sulphites statement disclosure, if applicable | X | X | X | X |
| 2.10 List by common name, preceded by the heading "non-medicinal ingredients", of all non-medicinal ingredients | X | X | X | Outermost label |
| 2.11 Other information (for example, recommended storage conditions) | X | X | X | X |
| 2.12 Lot number | X | X | X | X |
| 2.13 Expiry date | X | X | X | X |
| 2.14 Security Feature, if applicable. | X | X | X | X |
| 2.15 If product contains mercury or its salts or derivatives as a non-medicinal ingredient, the quantity of mercury in the product | X | - | X | Outermost label |
| 3.0 Cautionary statements and child resistant packages: | ||||
| 3.1 Cautionary Statements and Child Resistant Packages (Section 97) | X | X | X | X |
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