How to Register Natural Health Products in Canada
By: Joanna Chudyk, SENIOR REGULATORY AFFAIRS SPECIALIST, email
Multivitamin gummies, herbal extracts, probiotics, hand sanitizers, and homeopathic medicines – what do all of these products have in common? They are all considered Natural Health Products (NHPs) in Canada. And they are all regulated under the Health Canada Food and Drugs Act.
Dell Tech’s consultants have years of experience with NHP regulations and can help you successfully obtain a Natural Health Product License from the Non-prescription Drug and Natural Health Products Directorate for any product type.
Some Non-prescription drug and Natural Health Product NNHPD monographs apply to both Drug Identification Numbers (DINs) and Natural Health Products (NHPs). Dell Tech is available for pre-registration product reviews to determine the appropriate pathway for your product.
What is a Natural Health Product?
Natural Health Products (NHPs) (or Dietary supplements in the US) are naturally occurring substances (vitamins, minerals, extracts, or isolates) commonly sourced from plants, animals, microorganisms, or marine sources. They can be in a variety of dosage forms including gummies, capsules, tablets, powders, creams, or lotions. Examples of common Natural Health Products (NHP’s) include:
- Vitamin or mineral supplements
- Essential oils
- Topical products like primary or secondary sunscreen
- Hand sanitizers
Health Canada and Natural Health Products Regulations
To legally sell a Natural Health Product (NHP), the product must undergo pre-market review with Health Canada’s Non-prescription Drug and Natural Health Products Directorate (NNHPD). Approved products are assigned a valid Natural Product Number (NPN). Sometimes you’ll hear this called an “NPN number”. A Natural Product Number (NPN) is a unique 8-digit number used to identify Natural Health Products (NHPs). The Natural Product Number must appear on the product’s label.
Homeopathic medicines, although regulated by the Non-prescription Drug and Natural Health Products Directorate (NNHPD), will be assigned a Drug Identification Number – Homeopathic Medicines (DIN-HM) instead of a Natural Product Number.
What is the Non-prescription Drug and Natural Health Product Ingredient Database (NNHPID)?
The Non-prescription Drug and Natural Health Product Ingredient Database (NNHPID) is a collection of medicinal and non-medicinal ingredients acceptable for addition to a Natural Health Product (NHP). If the ingredient in your formula is not present in the database it cannot appear in your formula.
If you wish to add a new ingredient to the database, an Ingredient Issue Form (IIF) can be submitted requesting an addition or modification of an existing ingredient database entry.
What is the NHP registration process?
To sell a Natural Health Product (NHP) compliantly you must apply to register your product and obtain a Natural Product Number (NPN). The process varies depending on whether or not the ingredients in your product belong to a Non-prescription drug and Natural Health Products Directorate (NNHPD) Monograph.
A monograph includes pre-cleared information relating to acceptable doses, dosage forms, health claims, and applicable risk statements on a product or single ingredient. If your product meets the conditions of use in one monograph, then you are permitted to attest to it for safety, efficacy, and quality.
The monographs play a vital role in the classification of your product. It impacts data necessary to submit and the timelines for approval. Natural Health Products (NHP) can fall into either Class I, II, or III, which are defined below:
Class I (Compendial)
Class I applications – 60-day approval – products that comply solely with one monograph for safety, efficacy, and quality. The Product License Application (PLA) is the only technical document required for submissions of this class.
Class II applications – products that will attest to 2 or more monographs for safety, efficacy, and quality. Submission packages require both the Product License Application (PLA) and Finished Product Specifications (FPS).
Class III applications – the product contains medicinal ingredients that do not belong to any existing monographs. A Product License Application (PLA), Finished Product Specification (FPS) and safety/efficacy data must be compiled by the applicant to support the product.
What safety and efficacy data is required to support a Class III submission?
Class III submissions are for products containing medicinal ingredients without an associated Non-prescription Drug and Natural Health Products Directorate (NNHPD) monograph. Due to the absence of pre-cleared information, the onus is on the applicant to compile the necessary safety and efficacy data to support the health claims of the product. The NNHPD has stringent requirements for any supporting evidence provided for review.
In general, high-quality double-blind, placebo-controlled, human clinical trials are considered sufficient to support safety or efficacy. The studies do not need to be conducted on your actual product and it is sufficient to have data for each ingredient without a monograph as long as the ingredient is comparable.
The dosage of the ingredient in the study must be at or below the dosage in the product, and the source materials and the route of administration must be identical to the product. Dell Tech has ample experience compiling data for the Non-prescription Drug and Natural Health Product Directorate (NNHPD) to support health claims and can help you set your application up for success.
What other considerations must be made when selling a Natural Health Product (NHP) in Canada?
In addition to ensuring all Natural Health Products (NHPs) hold a valid Natural Product Number (NPN), all Canadian sites (manufacturer, packager, labeler, importer) must hold a valid Site License (SL). Site Licenses (SLs) have their own submission process and requirements. Any establishment must follow Good Manufacturing Practices (GMPs). To determine if a site is registered with the Non-prescription Drug and Natural Health Product Directorate (NNHPD) a search can be conducted through the Site License and Foreign Site Reference Number Holders List. Dell Tech is available to help register your site or amend any existing site licenses.
Moreover, you must ensure your product label is compliant with the Natural Health Products Regulations. On July 6th, 2022, the revised NHP labelling regulations were published which outlined more stringent labelling requirements for all Natural Health Products (NHPs). The deadline for compliance for products licensed before June 21st, 2025 is June 21st, 2028. Products licensed on or after June 21, 2025 must comply immediately.
What costs are associated with NHP registrations?
There are currently no costs associated with obtaining a Natural Health Product License (PL) or selling a Natural Health Product (NHP) in Canada. However, cost recovery is expected to be implemented in 2025 for submissions of all types, in addition to an annual Right to Sell fee for each marketed product holding a valid Natural Product Number (NPN).
The proposed fees for Natural Health Products (NHPs) have been published but the timeline for the final fees has not yet been established.
How Dell Tech Can Help You Register a Natural Health Product in Canada
Dell Tech is available to assist your company with all things related to natural products. Our team has expert knowledge of natural health products regulations to conduct formula assessment, label review, product license applications, site licensing, good manufacturing practices consultation and more! We can act as your main contact with Health Canada through every step of the process.