2024 Natural Health Products (NHP) Licensing in Canada - Licensing Guide
In order for manufacturers to sell natural health products (NHPs) in Canada, they must acquire a Natural Product Number (NPN) and a site licence from Health Canada's Natural and Non-prescription Health Products Directorate.
For natural health product licences, a Product Licence Application (PLA) must be submitted to Health Canada for assessment and approval. The PLA must provide comprehensive information about the product, including a complete list of medicinal ingredients and associated health claims. Upon submission, Health Canada reviews the PLA to ensure the product's safety and efficacy. Applications meeting the standards for safety, efficacy, and quality are granted licensing approval, along with the assignment of a Natural Product Number to the product.
For site licences, a different application must be submitted for the activities performed by the responsible party. This entails submission of a site licence application and contain information related activities performed.
In addition to product and site licensing, natural health products sold in Canada must meet the requirements set out in the Natural Health Products Regulations and follow Good Manufacturing Practices (GMPs) for natural health products. This includes meeting the labelling requirements and marketing the product in accordance with the granted natural health product licence and the scope of its health claims.
Learn more about the licensing process below.
Is my product a Natural Health Product?
Several different factors must be considered to determine if a product falls under the natural health product definition. According to the definition published by Health Canada;
"Natural health products (NHPs) are naturally occurring substances that are used to restore or maintain good health. They are often made from plants, but can also be made from animals, microorganisms and marine sources. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops."
The following product categories are considered to be a natural health product that requires a federal NPN licence:
Vitamins and minerals
Herbal remedies and herbs with health claims
Homeopathic medicines
Probiotics/Bacteria
Nosodes
Enzymes
Amino Acids
Essential fatty acids
Traditional medicines such as Traditional Chinese Medicine and Ayurveda
Workout supplements
Nicotine pouches
About Product Licence Applications for Natural Health Products
To acquire a Natural Product Number (NPN), manufacturers need to submit a Product Licence Application (PLA) package to Health Canada for risk assessment. The application package should include the PLA form and additional natural health product information, such as scientific evidence and ingredient specification documents.
There are three application classes - 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.
Monographs are compilations of information provided by Health Canada, detailing pre-approved medicinal ingredients suitable for use in natural health products along with their specifications. These monographs, accessible in the Natural Health Product Ingredient Database, serve as resources for applicants to substantiate the safety and effectiveness of their products.
To determine what class of applications is best suited for your products, the following class-specific information should be noted:
Class I PLA for Natural Health Products: Class I applications are designated for submissions validating a single monograph. This encompasses both single-ingredient monographs and product monographs containing multiple ingredients within a single monograph. Applicants are eligible to attest to the chosen monograph only if they fully comply with its specifications and requirements. Furthermore, for Class I applications, applicants are restricted to using only the health claims included in the validated monograph. Any additional health claims or purposes of use are not permitted unless already included in the monographs.
Class I applications take approximately 60 days of review by Health Canada, making them subject to the shortest performance standard among the three application classes.
Class II PLA for Natural Health Products: Class II applications are similar to class I applications in that they both attested to the already pre-cleared information published by Health Canada. Class II applications are submissions that use more than one monograph to substantiate the safety and efficacy of the product. In other words, applicants using more than one monograph to support the safety and efficacy of their product should submit a class II product application. As with class I applications, applicants can attest to Health Canada's monographs only if all specifications of the monograph are met. Additionally, only the health claims listed in the attested to monographs can be included on the application and the product label.
Class II applications take approximately 90 days for Health Canada to review.
Class III PLA for Natural Health Products: Class III applications are primarily designated for novel products. These may include natural health products containing new ingredients not listed in Health Canada's monographs, products making claims beyond the scope of the monographs, or products failing to meet the specifications outlined for monographed ingredients. Such applications necessitate applicants to provide additional evidence substantiating the safety and effectiveness of the medicinal ingredient(s) in the product.
Applicants are required to submit a minimum of two documents supporting the safety and efficacy of the non-monographed ingredient in the product. These documents can encompass various forms of evidence, such as clinical studies, entries from traditional medicine sources (pharmacopoeias), or monographs from other countries, and other scientific evidence. For instance, a clinical study evaluating the safety and effectiveness of a specific ingredient on humans at a dosage comparable to that present in the product, and conducted with randomized, placebo-controlled parameters, generally constitutes acceptable evidence.
Class III applications take approximately 310 days for Health Canada to review, as additional time is required to assess the product and ensure that there are no safety risks or potential adverse reactions for the novel ingredient(s) or product.
Finished Product Specifications (FPS) for Natural Health Product Applications and Ingredient Testing
In addition to a product licence application, applicants must also include a Finished Product Specifications (FPS) document. This document outlines the ingredient specifications of the product and summarizes what testing has and will be performed on the product and ingredients within. This includes information on tolerance limits, potency of constituents, ingredient specific parameters, heavy metal testing, and dosage form specific parameters.
Most ingredients should be tested in accordance with the United States or European Pharmacopoeias, unless additional rationale for deviation is presented. For example, some herbal remedies might not have a pharmacopeial standard. In which case, information about the quality of the ingredient and testing parameters might be outlined in the clinical evidence provided by the applicant. This information should be outlined in the FPS.
Information Request Notices (IRNs) for Natural Health Product Applications
Throughout the application review phase, Health Canada has the authority to issue Information Request Notices (IRNs), which seek additional details regarding the product. In the case of Class III applications, an IRN may be issued if the provided evidence fails to substantiate the product's safety and/or effectiveness, prompting the applicant to either revise the formulation or remove the ingredient from the product. Subsequently, applicants are allotted a period of 7 calendar days to address the IRN, choosing from the options presented by Health Canada.
Natural Health Product Licence Issuance
Once the product licence application is reviewed, a decision is made. A positive licensing outcome results in the applicant receiving a product licence and an eight digit Natural Product Number (NPN). The licensed product is added to the Licensed Natural Health Products Database (LNHPD) and core product information is listed for public records.
Companies and applicants should retain a copy of the issued licence for future use and personal records.
Rejection of Product Licence Applications
In the event that an application for a health product is rejected, applicants can re-submit the application to Health Canada once the necessary changes have been introduced, ensuring that all regulatory requirements are met prior to re-submission. However, the application process starts anew and will be subject to the full timeline associated with the particular application class. For example, a resubmission of a rejected class II product licence application will be subject to another 90-day review.
Post-Licensing Considerations for Natural Health Products: Product Labelling
After obtaining licensing, further attention must be given to the labelling and marketing of the product prior to its sale. Natural health products' labelling must adhere to the regulations outlined in the Natural Health Product Regulations and associated guidance documents, such as the Guidance document: Labelling of Natural Health Products. Adherence to these regulations ensures that the product labels provide accurate information, remaining truthful and not misleading.
These referenced documents specify both the required information on the label of natural health products and the manner of its presentation. This encompasses technical aspects like font style, color, and size. Recently, Health Canada has updated labelling requirements and introduced a standardized approach that includes a Product Facts Table (PFT). The introduction of the PFT aims to standardize how essential product information is presented, resembling the labeling approach used for pharmaceutical drugs. Alongside the PFT, product labels must include details such as the brand name, Natural Product Number, net quantity in the immediate container (expressed in weight, measure, or count), lot number, and expiration date.
Finally, it's crucial for manufacturers to consider bilingual requirements for product labelling. Specifically, all natural health products must feature core label text translated into both English and French, ensuring that licensed information is presented in both official languages on the product label. In the case of a Product Facts Table (PFT), information should also be listed in both official languages.
Post-Licensing Considerations for Natural Health Products: Product Marketing
Marketing of licensed natural health products must stay within the scope of licensed health claims. This means that marketing claims should align with those authorized by Health Canada and not exceed their approved scope. Moreover, the marketing of licensed products must take place on Canadian websites, ensuring that non-compliant products are not marketed to Canadian consumers. In many instances, companies opt to establish a separate domain for their brand to sell products to Canadian consumers, ensuring compliance with Canadian regulations and standards.
For example, a United States-based company cannot sell unlicensed natural health products to Canadian consumers until they obtain the necessary licenses. Therefore, they establish a website to exclusively feature products that are already licensed and compliant, specifically tailored for the Canadian market. This involves removing any natural health products that have not yet undergone review by Health Canada. Furthermore, marketing terminology used in the United States is adjusted to conform to the requirements of the natural health product licence in Canada, ensuring that no unauthorized claims are made.
Post-Licensing Regulation of Natural Health Products
Natural health products are under Health Canada's oversight both before and after they enter the market. The pre-market phase involves product review prior to market entry, while the post-market phase entails ongoing monitoring of products already within the market.
During the pre-market phase, natural health products undergo thorough review to ensure compliance with regulatory standards before they are introduced to consumers. Health Canada oversees this process to assess factors described earlier.
Once natural health products are on the market, responsible parties, including product license holders, are tasked with monitoring adverse events and complaints associated with their products. They are required to promptly inform Health Canada of any product-related risks they identify, including notifications regarding product recalls and submissions of case reports detailing adverse reactions.
Overall, the pre-market and post-market regulatory processes work together to ensure the safety and effectiveness of natural health products, both before they reach consumers and while they are available on the market.
Summary
Obtaining licenses for natural health products demands a thorough understanding of Canadian regulatory standards and the licensing protocols. Applicants must ensure that the information they provide to Health Canada is precise and not misleading, including accurate declaration of ingredient specifications and a comprehensive listing of all ingredients.
The duration of the product licensing process varies, typically spanning between 2 to 10 months. However, additional time is often necessary for information gathering and reformulation efforts. In certain instances, further scientific research is imperative to validate the safety and effectiveness of ingredients not covered by existing monographs. Consequently, the preparatory phase frequently extends the licensing timeline.
Beyond product licensing, manufacturers must determine whether they require a site license for their operations. For example, companies engaged in product manufacturing within Canada must secure a manufacturing site license prior to production and sale. Conversely, companies importing finished products into Canada must obtain an import license. Products must be manufactured according to Good Manufacturing Practices and pharmacopeial standards.
