The majority of health supplements available in Canada are considered Natural Health Products (NHPs) and must be approved by Health Canada prior to commercialization. This guide provides an overview of the requirements for health supplements available in Canada, including licensing, compliance, timelines, costs, and import conditions.
Regulatory Authority for Health Supplements in Canada
The Natural and Non-prescription Health Products Directorate (NNHPD), under Health Canada, regulates the safety, quality, label, and health claims of health supplements prior to their sale. Until products meet the Natural Health Products Regulations (NHPR), they cannot be sold in the Canadian market.
What Are Health Supplements Under Canadian Regulations?
Most of the health supplements sold in Canada are classified as Natural Health Products (NHPs). These are specified on the list of vitamins, minerals, herbal products, probiotics, amino acids, and traditional medicines regulated under the Natural Health Products Regulations (NHPR).
Compliance Checklist for Health Supplement Approval in Canada
When applying for approval, make sure:
- The goods are classified correctly.
- The product licence strategy is defined.
- Use of all ingredients is allowed in Canada.
- There is satisfactory evidence to support health claims
- Product labels meet the requirements of Health Canada.
- The Product Licence Application is complete and accurate.
- The manufacture, packaging, and labelling, as well as the import of products, are compliant with GMP standards.
- Where necessary, there is a Site Licence.
Health Supplements Registration Process in Canada (Step-by-Step)
The licensing process includes the following steps:
Step 1: Check Product Classification
Identify if a product meets the requirements of a Natural Health Product (NHP) by considering the ingredients, intended use, dosage form, and claims.
Review:
- Product formulation
- Intended claims
- Route of administration
- Dosage form
Step 2: Assess Ingredient and Claim Eligibility
Review:
- Natural Health Products Ingredients Database (NHPID)
- NHP Monographs
- The Licensed Natural Health Products Database (LNHPD) is a collection of all natural health products that have been registered for use in Canada.
Confirm:
- Ingredients are permitted
- Claims are supported
- Proposed doses are acceptable
Step 3: Determine the Application Pathway
| Class | Description |
| Class I |
Completely complies with an existing monograph
|
| Class II |
Minor variations from the requirements for the monograph are acceptable
|
| Class III |
New ingredients, claims, or formulations
|
The length of time to review and the types of evidence required vary by application class.
Step 4: Make the Product Licence Application (PLA)
Submit a Product Licence Application via Health Canada’s Web PLA/ePLA system.
Include:
- Product name
- Recommended use
- Medicinal ingredients
- Non-medicinal ingredients
- Dosage information
- Risk statements
- Supporting evidence
- Label text
Step 5: Submit Application
Send the completed PLA to Health Canada electronically.
Before submission, verify:
- All ingredient information is correct
- Claims are supported by evidence
- Labels are compliant with regulatory regulations
- You have all the necessary documents
Step 6: Answer to Information Requests
Health Canada can ask for more details about the following:
- Unsupported claims
- Missing evidence
- Labeling deficiencies
- Ingredient inconsistencies
Step 7: Get the Natural Product Number (NPN)
If approved, Health Canada will issue an NPN that will be on the product label before it is commercialized.
Step 8: Secure Site Licensing
If the company is manufacturing, packaging, labelling, or importing NHPs in Canada, a Site Licence will be required.
Step 9: Maintain Post-Approval Compliance
Companies must:
- Maintain GMP compliance
- Report changes in the product that are applicable
- Keep licensing information up to date as needed
- Address complaints and recalls
- Ensure adherence to labels and claims
Registration Workflow at a Glance
The registration workflow includes product classification, ingredient review, application class determination, PLA submission, Health Canada review, issuance of the NPN, site licensing, and commercialization. If the product formulation changes or a different ingredient is introduced, a new classification assessment may be required before submission or commercialization.
Documents Required for Health Supplements Registration in Canada
Common documents submitted are:
- Product name and dosage form
- Medicinal and non-medicinal ingredient details
- The recommended use and dosage are included
- Safety and efficacy data are provided
- Risk statements and warnings
- Proposed label text
- Product specifications and testing data (where applicable)
Health Canada Labelling Requirements for Health Supplements in Canada
Labels must include:
- Natural Product Number (NPN)
- Use or purpose recommended
- The recommended dosage or instructions for use
- Medicinal ingredients and ingredients for non-medical purposes
- Warnings, cautions, and contraindications
- English and French labelling
Health Canada Licensing Requirements for Health Supplements in Canada
Product Licence Requirements:
- Product must be given an NPN prior to sale
- Evidence to support claims is required
- Product information needs to be identical to the approved licence
Site Licence Requirements:
- Required for manufacturers
- Required for packagers
- Required for labellers
- Required for importers
GMP Requirements for Health Supplements in Canada
Health Canada’s GMP requirements apply to companies engaged in the manufacturing, packaging, labelling, storing, distribution, or importation of NHPs.
Some key GMP requirements are:
- Product specifications
- Personnel and quality monitoring
- Controls for premises and equipment
- Testing requirements
- Distribution records
- Complaint handling procedures
- Recall procedures
Importers shall keep records that prove compliance with the applicable GMP of foreign-manufactured products.
Health Claims and Advertising Regulations in Canada
All health claims on labels, websites, ads, and promotional materials should be consistent with the approved product licence.
Key requirements include:
- Support with evidence of claims is required
- All claims must be consistent with the approved NPN
- Nothing in an advertisement shall be false or misleading
- The rules for digital marketing claims are the same as those for product labels
Import Regulations for Health Supplements in Canada
Prior to importation and sale, Natural Health Products are required to comply with Canadian regulatory requirements.
Importers must:
- Have a valid Site Licence
- Ensure manufacturing premises are GMP certified
- Keep import & distribution records
- Make sure that labelling meets Canadian standards
- Ensure recall/reporting procedures are in place and adhered to for complaints
Health Supplement Registration Timelines in Canada
There are varying review period lengths for different applications based on the class of application, complexity of the product, and level of supporting evidence.
The following are some of the determining elements that impact review time:
- Monograph alignment
- Novel ingredients
- Novel claims
- The completeness of the application
- Health Canada information requests
Applications falling under Health Canada monographs are typically processed more quickly than those that need scientific assessment.
Health Supplement Registration Costs in Canada
The registration fees vary according to the formulation of the product, the claims to be made, the required evidence, and the preparedness of the product for registration.
Common cost drivers are:
- Regulatory assessment
- Dossier preparation
- Scientific evidence reviews
- Develop labels and translations
- The importance of testing and quality documentation
- GMP compliance activities
- Site Licence requirements
Conclusion
Developing a proper licensing strategy and ensuring compliance with GMPs during the entire product lifecycle is important to enter the Canadian market.
Getting in touch with the regulatory partner is the best approach for manufacturers expanding to Canada. Artixio helps with registration strategy, including product licensing, site licensing, labelling, and compliance in Canada. For more information, get in touch with us today at info@artixio.com.
FAQs
Do Health Supplements Require Approval Before Sale in Canada?
Yes. A majority of health supplements that are classified as a Natural Health Product (NHP) must be licensed and approved by the NPN for sale.
What Is an NPN?
Natural Product Numbers (NPNs) are the product licence numbers granted by Health Canada to approved Natural Health Products.
Is a Site Licence Required for Imported Health Supplements?
Yes. Natural Health Product importers need to have a valid Site Licence and meet GMP requirements.
Can Foreign Manufacturers Obtain a Canadian Site Licence?
Foreign manufacturers can be issued a Foreign Site Reference Number (FSRN), and Canadian importers continue to be responsible for compliance.
