Frequently Asked Questions (FAQ) – Product Licensing in Canada
What is a Natural Product Number (NPN)?
A Natural Product Number (NPN) is an eight-digit identification number issued by Health Canada to approved Natural Health Products (NHPs). It confirms that the product has been assessed for safety, efficacy, and quality and is authorized for sale in Canada.
What is a Product Licence Application (PLA)?
A Product Licence Application (PLA) is the submission required to obtain an NPN for a Natural Health Product. It includes detailed information on ingredients, dosage, recommended use, risk information, and supporting evidence for safety and efficacy.
How long does it take to get an NPN in Canada?
Timelines for NPN approval vary depending on the complexity of the product and the submission pathway. Some applications may be processed within a few months, while others—particularly those requiring additional evidence—can take several months to a year.
What is a Veterinary Health Product (VHP)?
Veterinary Health Products (VHPs) are low-risk products intended for use in animals, such as supplements, vitamins, and grooming products. These products are regulated by Health Canada under a notification-based system rather than full pre-market approval.
What is a Notification Number (NN) for VHPs?
A Notification Number (NN) is issued by Health Canada once a Veterinary Health Product has been successfully notified. It confirms that the product meets the requirements of the VHP notification program and can be legally marketed in Canada.
How do I get a VHP Notification Number (NN)?
To obtain an NN, companies must submit a notification to Health Canada that includes product details, ingredients, and labelling information. The product must meet eligibility criteria and use only permitted ingredients.
Do cosmetics need to be approved by Health Canada?
Cosmetics do not require pre-market approval in Canada. However, manufacturers and importers must submit a Cosmetic Notification Form (CNF) to Health Canada within 10 days of first sale.
What is a Cosmetic Number (CN)?
A Cosmetic Number (CN) is assigned after submitting a Cosmetic Notification Form. It confirms that Health Canada has been notified of the product, but it does not represent formal approval.
What are the labelling requirements for NHPs, VHPs, and cosmetics?
Each product category has specific labelling requirements set by Health Canada. These include mandatory information such as product identity, ingredients, directions for use, risk statements, and bilingual (English/French) labelling. Non-compliance can lead to delays, refusals, or enforcement action.
Can you help with label compliance and claims review?
Yes. Nexus NHP provides comprehensive label review services to ensure compliance across NHPs, VHPs, and cosmetics. This includes assessing claims, formatting, ingredient disclosure, and alignment with regulatory requirements.
Do I need a regulatory consultant to submit my product?
While it is possible to submit applications independently, many companies choose to work with a regulatory consultant to reduce the risk of delays, refusals, or non-compliance. Expert guidance can significantly improve the efficiency and success of your submission.
What services does Nexus NHP provide for product licensing?
Nexus NHP offers end-to-end regulatory support, including:
NHP Product Licence Applications (PLA) and NPN submissions
VHP notification submissions and NN applications
Cosmetic Notification Forms (CNF) and compliance support
Product classification and regulatory strategy
Label review and compliance across all product types
Still have questions?
Regulatory pathways can vary depending on your product and business model.
Contact Nexus NHP to discuss your specific product and receive tailored guidance.