Most health supplements available in Canada are considered Natural Health Products (NHPs) and must be approved by Health Canada prior to commercialisation. After the 2021 audit of Health Canada’s NHP programme, several initiatives have come into place. So, those manufacturing, labelling, or importing NHPs need to know the compliance regulations to avoid any complications.
This guide provides an overview of the requirements for these products available in Canada, including licensing, compliance, timelines, costs, and import conditions.
Regulatory Authority for Natural Health Products in Canada
The Natural and Non-prescription Health Products Directorate (NNHPD), under Health Canada, regulates the safety, quality, labelling, and health claims prior to their sale. Until products meet the Natural Health Products Regulations (NHPR), they cannot be sold in the Canadian market.
The NNHPD is responsible for product licensing, while the Health Product Compliance Directorate oversees site licensing and GMP inspections. Under Canada’s framework, a product license authorises a specific NHP for sale with a Natural Product Number (NPN) issued. On the other hand, a site licence authorises the applicable Canadian site to manufacture, package, label, or import NHPs for sale and requires compliance with the applicable GMP provisions.
What Are Natural Health Products Under Canadian Regulations?
These are naturally occurring substances that help restore or maintain good health. Often made from plants, animals, microorganisms, or marine sources, they can be found in the form of tablets, capsules, solutions, creams, drops, tinctures, or ointments. In Canada, they can also be called “complementary” or “alternative” medicines, including herbal remedies, homoeopathic medicines, vitamins and minerals, amino acids, probiotics, traditional medicines, and other products.
Several routine consumer products like toothpastes, shampoos, antiperspirants, mouthwashes, and facial products also fall in this category. These products are consumed and marketed for various health reasons, covering the prevention and treatment of an illness or a condition. They can reduce health risks or maintain good health, generally being considered safe as over-the-counter products.
Natural Health Products Licensing Process in Canada
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). It’s necessary to assess the substance and function criteria before submitting the Product License Application (PLA). Review composition, dosage form, intended use, administration route, proposed claims, and medicinal and non-medicinal ingredients.
Step 2: Assess Ingredient and Claim Eligibility
Review the Natural Health Products Ingredients Database (NHPID) and NHP Monographs. The Licensed Natural Health Products Database (LNHPD) is a collection of all natural health products that have been licensed for use in Canada. Confirm that ingredients are permitted and claims are supported, and proposed doses are acceptable.
Step 3: Determine the Application Pathway
There are currently three application classes that affect the evidence requirement and application review time. Check them in the table below:
| 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 requiring a fuller assessment |
Step 4: Make the Product License Application (PLA)
Submit a Product License 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 + Administration route + Claims + Product information
Step 5: Submit Application
Send the completed PLA to Health Canada electronically. The current policy establishes rules for designated parties acting on behalf of an applicant, including the use of a Designated Party Authorisation (DPA) where applicable. Health Canada can subsequently request additional information through an Information Request Notice (IRN). IRN response periods can range from 5 to 15 calendar days, depending on the complexity of the request.
Step 6: Health Canada Screening & Assessment
Health Canada screens applications for regulatory completeness. Where applicable, they assess them against the selected monograph parameters. Applications can be refused for reasons including the following:
- The product does not meet the NHP definition
- Incomplete or inaccurate information
- Missing label text
- Lack of supporting safety/efficacy evidence
- Missing required attestations
- Failure to meet relevant monograph parameters.
For Class III applications, Health Canada conducts a substantive assessment of the relevant safety, efficacy, and quality requirements.
Step 7: Get the Natural Product Number (NPN)
If approved, Health Canada will issue an eight-digit NPN that will be on the product label before it is commercialised. Ensure it’s on the product label.
Step 8: Secure Site Licensing
If the company is manufacturing, packaging, labelling, or importing NHPs in Canada, a Site License will be required. It is linked to specific activities and locations. Such licensing activities need compliance with GMP in Part 3 of the NHP regulations.
Step 9: Maintain Post-Approval Compliance
Companies must maintain GMP compliance and report changes in the product that are applicable. They should keep licensing information up to date as needed and address complaints and recalls. Lastly, they must ensure adherence to labels and claims.
Documents Required for Natural Health Products Licensing in Canada
The ingredients used, application type, claims, supporting evidence, etc., affect what documents will be needed for NHP licensing. Several components that Health Canada’s current policy identifies are as follows:
Core Application Information
- Completed current Web PLA
- Product information
- Medicinal and non-medicinal ingredient information
- Recommended use and conditions of use
- Dosage and route
- Required label text
- Appropriate attestations
Supporting texts (as needed)
- Safety evidence
- Efficacy evidence
- Quality information
- Monograph attestations
- Supporting scientific information
- Letters of access, where another company’s submission is being referenced
- Animal Tissue Forms, where applicable
Important Updates
As of June 15, 2026, Health Canada no longer expects Finished Product Specifications (FPS) to be submitted with Class II and Class III PLAs and amendments. FPS also do not need to be submitted for Class I applications under the current management policy.
Health Canada explicitly states that an FSRN was not required under the regulations, was not equivalent to a foreign site licence, and did not authorise a foreign site to export directly to Canada without a licensed Canadian importer (Feb 16, 2026).
NHP Licensing Timelines in Canada
Canada’s current system is risk- and class-based. Health Canada is managing application workload through prioritisation.
Class I
Health Canada hasn’t provided a particular service standard timeline for Class I applications. However, past years’ records show it to be 60 calendar days for screening the Compendium and Class I assessment. This applies to submissions sent through the electronic PLA form. For other modes, 180 calendar days will be taken for assessment.
Class II
Health Canada introduced workload management for Class II submissions in June 2025 and states that it will strive to meet a 90-calendar-day service standard for qualifying prioritised Class II applications, subject to workload and available resources.
Class III
For qualifying prioritised Class III submissions, Health Canada states that it will strive to meet a 210-calendar-day service standard.
These are service standards, not guaranteed approval timelines. Health Canada also states that the review order for applications received from December 15, 2025, onwards is based on the application’s receipt date, subject to the current workload-management framework.
NHP Licensing Costs in Canada
Health Canada has proposed a cost-recovery framework for NHP product evaluation, site licensing and the right to sell. However, the department is revisiting the implementation following programme adjustments. Companies should verify the current fee position directly with Health Canada before budgeting or filing.
Compliance Checklist for NHP Approval in Canada
When applying for approval, make sure:
- The product meets the definition of an NHP.
- The applicable medicinal ingredients are permitted.
- Medicinal and non-medicinal ingredients are correctly identified.
- Ingredients comply with applicable NHPID information and restrictions.
- Recommended use and dosage are supported.
- Safety and efficacy evidence are appropriate for the product.
- Claims are supported.
- The label complies with the Natural Health Products Regulations.
- The correct application class and type have been selected.
- The required attestations and supporting information are available.
- The relevant site information and site-license requirements have been addressed.
Labelling Requirements for Natural Health Products in Canada
Labels must include:
- Natural Product Number (NPN) or DIN-HM (Homoeopathic medicine number)
- 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
- Expiry date, directions to use, lot number, net amount
Important 2025-2028 Labelling Transition
Health Canada published a Ministerial Order in March 2025 providing a temporary exemption from the new NHP labelling requirements. The transition allows applicable NHPs to continue using the previous labelling requirements until June 22, 2028, subject to the Order’s conditions.
GMP Requirements for Natural Health Products 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.
Important: GMP compliance is a site-level regulatory obligation. It should not be confused with a requirement to submit a standalone GMP certificate with every product licence application.
Health Claims and Advertising Regulations for NHPs in Canada
All health claims on labels, websites, ads, and promotional materials should be consistent with the approved product license. Key requirements include evidence to back claims. 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 Natural Health Products in Canada
Prior to importation and sale, complementary medicines are required to comply with Canadian regulatory requirements. Importers must have a valid Site License and ensure manufacturing premises are GMP certified. They should keep import & distribution records and make sure that labelling meets Canadian standards. Further, they must ensure recall/reporting procedures are in place and adhered to complaints.
Post-Market Compliance for NHPs
License holders must maintain compliance with their product license and applicable regulations. It includes requirements relating to changes, complaints, recalls, quality, and safety. NHP market authorisation holders also have adverse reaction reporting obligations.
Health Canada’s current guidance applies the reporting requirements to marketed NHPs and directs reports through the Canada Vigilance system. Companies should also maintain processes for the following:
- Complaint handling
- Adverse-reaction reporting
- Product withdrawals and recalls
- GMP compliance
- Label and claim monitoring
- Record keeping
- License amendments and notifications.
Conclusion
Developing a proper licensing strategy and ensuring compliance with all the rules during the entire NHP 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 compliance 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 Natural Health Products Require Approval Before Sale in Canada?
Yes. All Natural Health Products (NHPs) require a product licence before they can be sold in Canada. Once Health Canada authorises the product, it is assigned an eight-digit Natural Product Number (NPN), which must appear on the product label.
What Is an NPN?
Natural Product Numbers (NPNs) are eight-digit product licence numbers granted by Health Canada to approved Natural Health Products. They are granted permission for sale in the country.
Is a Site License Required for imported NHPs?
Yes. Natural Health Product importers need to have a valid Site Licence and meet GMP requirements. Importers must also ensure that NHPs manufactured, packaged or labelled at foreign sites meet Canadian GMP requirements or an equivalent standard and must maintain appropriate evidence of compliance.
Can Foreign Manufacturers Obtain a Canadian Site License?
Foreign manufacturers should work with the Canadian importer and site-licence holder to ensure that foreign manufacturing, packaging and labelling sites meet applicable Canadian GMP requirements or equivalent standards. The former Foreign Site Reference Number (FSRN) process was discontinued by Health Canada on February 16, 2026.
