Canada
Natural Health Product (NHP)
Is my product a Natural Health Product?
Pursuant to Natural Health Products Regulations, Natural Health Products (NHPs) are defined as:
- Probiotics
- Herbal remedies
- Vitamins and minerals
- Homeopathic medicines
- Traditional medicines such as traditional Chinese medicines
- Other products like amino acids and essential fatty acids
Several everyday consumer products, like certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes are also classified as Natural Health Products in Canada. All NHPs require a product licence with a Natural product number (NPN) before being sold in Canada.
We understand that identifying if your product falls in the category of a NHP, food product or a cosmetic can be confusing, our team is here to handle everything for you from product classification to NPN approval.
Product Licence Application
Why is NPN needed?
Legal Requirement
To sell Natural Health Products (NHPs) in Canada, an 8-digit Natural Product Number (NPN) must be acquired from Health Canada's Natural and Non-prescription Health Products Directorate.
Consumer Confidence
The NPN serves as a clear indicator to consumers that the product has been reviewed and approved for sale by Health Canada.
Regulatory Oversight
The NPN allows Health Canada to monitor and track NHPs, ensuring compliance with the Natural Health Products Regulations and providing a mechanism for responding to any safety concerns.
How to get a Natural Product Number (NPN)?
To acquire a Natural Product Number (NPN), the applicant needs to submit a Product Licence Application (PLA) package to Health Canada for risk assessment. There are three classes of product licence application – class I, II, and III, each requiring varying levels of safety risk evaluation based on factors such as the product’s formulation, the novelty of its ingredients, and the referenced monographs.
We can take care of every step of the process so that you can relax and focus on your business.
Label Compliance
All Natural Health Products (NHPs) are required to be labeled and packaged according to the Natural Health Products Regulations before sale in Canada. The inner and outer labels of a NHP must contain a list of information that helps consumers make more informed choices about products they take. At FG, our team of label compliance experts can review your labels and provide guidance on ensuring that these comply with the regulations.
Site Licence Application to Manufacture, Package, Label and/or Import NHPs
Health Canada’s site licensing system requires all Canadian manufacturers, packagers, labellers, and importers be licensed.
Our team can help ensure a smooth NHP Site Licensing process for you, we will work with you to review your site’s Standard Operating Procedures (SOPs) and associated documentation against Good Manufacturing Practices (GMPs). We will guide you throught the process to ensure standards and procedures are implemented with regards to the manufacturing premises, equipment, personnel, operations, product specifications, stability, recall procedures, quality assurance, and records. Our team will prepare and submit all necessary documentation & liaise with the NNHPD on your behalf.
Cosmetics
Notifications
According to section 30 of the Cosmetic Regulations, all manufacturers and importers must notify Health Canada within 10 days after they first sell a cosmetic in Canada. Failure to notify may result in a product being denied entry into Canada or removed from sale.
How can FG help you with Cosmetic Notifications?
Our team of experts can assist you through the process of submission or re-submission of Cosmetic Notification forms. We can also assist you with following:
- Reviewing all the ingredients in cosmetic formulation and checking if the product contains any ingredients on the ‘Ingredient Hotlist’ (restricted or prohibited substances in cosmetics).
- Prepare and submit your cosmetic notification form to Health Canada.
- Make the necessary changes/corrections and re-submit the Cosmetic Notification Form, as required.
Amendment of Cosmetic Notification Forms
Re-submission of the Cosmetic Notification Form (CNF) to Health Canada is required if any changes that affect a Cosmetic Notification Form (CNF) are made. Health Canada must be notified of the change within 10 days of the modification. Modifications may include:
- Changes in cosmetic formulation
- Changes in product’s brand name
- Discontinuation of sale
- Change in company’s name and address
- Change in contact information of the company
Label Compliance
Our team of Canadian cosmetic labelling experts can help you analyze your cosmetic product labels for compliance with Health Canada regulations. We provide essential guidance on ingredient declaration, allergen labeling, and health claims specific to cosmetic and personal care products.
Whether you’re a cosmetic manufacturer, importer, or distributor, our experts can help ensure your products meet all Canadian regulatory requirements.
Canada Responsible Person
Why do you need a Responsible Person for cosmetics in Canada?
Effective October 2024, Canadian regulations for cosmetics define a “manufacturer” as a) any person in Canada selling cosmetics under their own name, and b) a responsible person in Canada authorized to represent a foreign brand. This means that the new regulation allows brands based outside of Canada to appoint a Canadian-based individual as their Responsible Person, who can then act effectively as the manufacturer’s representative.
What is the role of a Responsible Person?
It is the role of a Responsible Person (also referred to as the manufacturer or importer, if no manufacturer is identified) to ensure that your cosmetic product remains compliant with the regulations and safety standards. The responsible person also liaises with Health Canada to provide additional information, as necessary.
Fiducia Globus can serve as your Canadian Responsible Person for ensuring that your products are both legally compliant and safe for consumers.
Amazon compliance
Sell on Amazon.ca with confidence — meet both Health Canada regulations and Amazon’s strict compliance requirements.
Selling cosmetics and Natural Health Products (NHPs) on Amazon Canada means navigating two layers of compliance:
- Health Canada’s regulations under the Food and Drugs Act, the Natural Health Products Regulations, and the Cosmetic Regulations.
- Amazon.ca’s product policy and documentation requirements, which closely align with Canadian law but are enforced through Amazon’s own approval process.
At Fiducia Globus, we provide end-to-end regulatory guidance so your products meet all legal and Amazon policy requirements before they reach Canadian customers. Whether you’re a local business or an international brand expanding to Canada, we help you launch quickly, avoid costly delays, and maintain full compliance.
Get your cosmetics and NHPs approved on Amazon.ca quickly and without compliance headaches.
Contact us today for expert regulatory guidance and complete Amazon Canada compliance support.