Natural Health Product Site Licensing Changes

Natural Health Product Site Licensing Changes

Mandatory Canadian and Foreign Site Reference Number (FSRN) and what this means to you…

As per the NHPR (regulations), you are responsible for providing the NNHPD with the Canadian site information prior to commencing the importation and/or sale of the natural health product. All information required is outlined in Part 1, Section 22 (1 & 2). If this information has not already been provided to NNHPD, please submit this information as a notification, as per section 12 (2) (b) of the NHPR.

Site Licensing Changes

You will be learning shortly if you haven’t already, that you must have a Canadian Site License to sell your natural health products in Canada. This means Canadians and foreign manufacturers alike.

Natural health products Site Licensing is a requirement of all Canadian and foreign companies who manufacture, package, label or import a natural health product for sale.

Companies must have a Site License that has been issued by the Natural Health Products Directorate (NHPD).

Currently, you might have product licenses that have stalled halfway through the process due to the lack of a Site License number (SL#). These applications cannot be submitted until you can provide the Site License number (SL#).

Older products submitted in the past without a Site License number will be asked to provide this number to the NNHPD. This means securing a GMP compliant manufacturing site then submitting the application the NNHPD.

We can provide you with that site license. We can also provide you with an Import License.

Licence Types – Within & Outside of Canada

The available types of applications are as follows:

  • Site Licence: A site licence is required for the physical site in Canada where any persons (business or individual) wish to manufacture, package, label, and/or import a NHP for sale.
  • Foreign Site Reference Number: A FSRN is issued to a manufacturer, packager and/or labeller of NHPs located outside of Canada, referred to as a foreign site. The reference number issued is not a site licence or authorization for direct export of NHPs into Canada, but rather, a unique reference number. The FSRN holder will engage in a partnership with a licensed Canadian importer in order to export NHPs into Canada.

Businesses that do not require a site licence:

  • 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 Natural Health Products 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 Natural Health Products Regulations. However, the products and activities must conform to the provisions outlined in Part 4 of the Natural Health Products 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.

Is your site licence expired?

Companies who have failed to submit their site licence renewal (regardless of the renewal cycle) 30 calendar days prior to the Site Licence’s expiration date will see their application for renewal refused. A new application will be required prior to initiating or resuming activities

Site License Application

update on April 30, 2022 (version 3.0) includes the following changes:

  • Addition of the “Changes Reporting to this application”/”notification types” section to capture notifiable changes to a Site Licence
  • Addition of fields to describe how the applicant’s Quality Assurance Person meets the qualification requirements described in the Natural Health Products Regulations
  • Restructuring of the Site Information module
  • Addition of new questions for sites requesting information on the timeframe to conduct activities
  • Implementation of dynamic GMP evidence lists for sites to better reflect the requirements listed in the Site Licensing Guidance Document
  • Addition of a NPN lookup in the Product Information module
  • Reworking of the supply chain questions under the Product Information module
  • Addition of a validation service to the form

We can provide you with consultation on site licenses.