I want to sell a Natural Health Product in Canada. What do I have to do?

In order to legally sell and advertise your products in Canada, you first need approval from the Natural and Non-Prescription Drug Directorate (NNHPD) in the form of an NPN, a Natural Product Number. They are the authority that reviews and issues product and site licenses in Canada based on the Natural Health Products Regulations.

a. Product Licensing

Before any natural health product can be sold (or even donated) in Canada, it must first undergo a pre-market review where it will be assessed for safety, efficacy, and quality. Evidence demonstrating this must be submitted to Health Canada by means of a product license application (one for each product). Products, which meet the required criteria, will be authorized for sale and each issued a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM).

b. Site Licensing

The Natural Health Products Regulations require any Canadian site where natural health products for sale are manufactured, packaged, labelled, and/or imported to have a site license. Businesses can choose to have a single site license (ie. your home formulation area) for all their operations or an individual license for each site (ie. home formulation area, garage storage area, leased space).

Site licenses are obtained by demonstrating that the above mentioned activities are conducted in a manner that is in line with the requirements of the Canadian Good Manufacturing Practices (GMPs) for NHPs. The requirements for a site license include both Standard Operating Procedures and Good Manufacturing Practices that are based on ISO 22716:2007 - Cosmetics - Good Manufacturing.

What is the process to import a natural health product into Canada?

How does a natural health product get approved for importing into Canada?

• Any person (business or individual) that brings into Canada a finished NHP for the purpose of sale is considered to be an importer under Part 2 of the Regulations.

• Importers that ship a product directly to the retailer without first storing the product require a site licence and, must be compliant with all the GMP requirements relating to the site licence.

Canadian importers must have a site license and the onus is on them to provide evidence that imported products come from sites that meet the Canadian Good Manufacturing Practices (GMPs), or equivalent standards.

The Canadian importer is responsible for submitting a Quality Assurance Report for each site with their site license application. Site licenses are issued only to Canadian sites (not to foreign sites). Foreign manufacturers will be covered under the Canadian importer’s site license.

Can I market my product without an NPN or DIN-HM?

No, all natural health products for retail sale in Canada must have valid a NPN or a DIN-HM before you are allowed to sell in Canada.

A site licence is not required by:

• A pharmacist, aboriginal healer, traditional Chinese medicine practitioner, or health care practitioner, who, at the request of a patient, compounds a NHP for the purpose of sale solely to that individual. For clarification on what activities performed by a practitioner requires a site licence, refer to the Natural Health Product (NHP) Compounding Policy.

• Distributors that do not import NHPs into Canada. A distributor is a person who sells NHPs to another person for the purpose of further sale in Canada. However, distributors must follow GMP (as stated in section 43 (1) of the Regulations).

• Persons (business or individual) performing the activities of growing, harvesting, cleaning, sorting, and/or importing raw material but do not produce a product that is ready for use or consumption by the consumer. For further clarification on how the NNHPD defines a raw material, refer to the Natural Health Product Raw Material Policy.

• Persons (businesses or individuals) that invoke section 37 of the Food and Drugs Act, to manufacture NHPs for the sole purpose of exporting outside of Canada as per the Import and Export Policy for Health Products under the Food and Drugs Act and its Regulations.

• Persons (businesses or individuals) that manufacture, package, label, or import NHP's solely for the purpose of a clinical trial as per section 26 of the Regulations. However, the products and activities must conform to the provisions outlined in Part 4 of the Regulations (Clinical Trials Involving Human Subjects). For more information on clinical trials, including GMP, see the Clinical Trials for Natural Health Products guidance document.

• Testing labs do not require a site licence. However, it is expected that the activity which is required to confirm that a NHP meets its finished product specifications be conducted in a manner that assures accurate and valid results.

Do I need to provide quality testing on my products?

Product licence holders are ultimately responsible for ensuring the quality of their licensed NHPs. The product licence applicant is required to confirm this responsibility by providing an attestation (in the product licence application (ePLA)) that the product will be manufactured, packaged, labelled, imported, distributed and stored in accordance with GMPs. It is the responsibility of the product licence holder to ensure that the product is handled in such a way as to ensure the product’s stability to the end of its shelf-life.

It is recognized that the product licence holder may rely on another party to produce the NHP, including establishment of the specification and testing the product for release and stability. As such, clear roles and responsibilities for developing and maintaining data and records should be established when the product licence holder relies on a third party to provide this information.

Documentation should be kept by the product licence holder that clearly defines the responsibilities between themselves and the contracted third parties. Such documentation may include a valid quality technical agreement between the manufacturer/ importer and/or the contracted third party or product licence holder that is signed and dated by the parties involved. It should also clearly state who is responsible for developing and maintaining the appropriate information/data, and/or performing any key functions for the regulatory compliance of the product that have been delegated by the product licence holder to another party. Data (e.g. specifications, testing, studies or standard operating procedures) should be available to Health Canada upon request.

Are cosmetics such as creams, shampoos, toothpastes, etc. regulated by the Natural Health Products Regulations?

Cosmetics are regulated as natural health products only if they meet both the function and substance components of the NHP definition. This refers to the intended use of the product, such as diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans; restoring or correcting organic functions in humans; or modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health. Products such as these typically fall within the Cosmetic-Drug Interface.

What are the costs for submitting a product and/or a site license application for a natural health product?

Presently, there are no costs or fees associated with the submission and review of product and site license applications*. However, the natural health products directorate will be initiating consultations with industry stakeholders on a proposed cost recovery framework for natural health products. As it has done in the past, the directorate will undertake a transparent and collaborative process to ensure that this framework is appropriate for the natural health products industry.

*There are costs involved with the applications for Mosquito Repellant (this falls under the PMRA) and Hard Surface Disinfectants (this falls under Health Products and Food Branch Inspectorate)

How does the Natural Health Products Directorate define Quality Assurance Person?

In the good manufacturing practice guidance document, the quality assurance person is defined as “the person who is responsible for assuring the quality of the natural health product before it is made available for sale. This person should be qualified by education/technical knowledge, training and experience relating to the specific activity (e.g., manufacturing, packaging, labelling and importing). Generally for small businesses, makers and solopreneurs that person is the owner of the business. Often in businesses like this, all hats are worn by the same individual. This is ok, but multiple hats should never be worn at one time! Your actions need to be specific to the role and the documentation you are completing and filling in that moment.

How do the new regulations affect my manufacturer or supplier?

The new Health Canada regulatory requirements have a direct impact on how natural health products are manufactured, imported and distributed throughout Canada.

Each organization that is involved in the overall supply chain of natural and non-prescription products (i.e. manufactures, packagers, labelers and importers) must have valid site licenses.

Also, in order for a product to be imported into Canada, the importation must be performed by a fully compliant facility that has been officially licensed by Health Canada. Failure to be compliant will result in the products not being allowed to enter the country or at very least be held at the border until the proper documents can be provided.

Want to know if a medicinal or non-medicinal ingredient is acceptable to Health Canada?

The Natural and Non-Prescription Health Products Ingredients Database is a vast source of information in terms of the science, ingredients and monographs that have been pre-cleared by Health Canada. This is public information approved by the NNHPD that is available for any person to reference. The principal use of this database is to validate ingredients for use in natural and non-prescription health products. If your product uses ingredients that are not in the database they need to be added, which may take some time. This is possible through a specific process and does require supporting evidence. Canadian Natural Health Product Registry can help you through this procedure.