A “Site Licence” is issued to Canadian importers, manufacturers, packagers and labellers, when they can provide sufficient evidence of procedures or processes that comply with Canadian Good Manufacturing Practices.

The company must provide evidence through Standard Operating Procedures (SOPs) that proper processes are in place; including receiving natural health products, clean premises with a good sanitation program, and an up-to-date recall system in place, among others, all with good records and GMP procedures.

In the case of manufacturers, packagers and labellers, equipment and a record of their maintenance and calibration are required (if appropriate).

If you are a company outside Canada, please refer to the Foreign Site Reference Numbers section below.

Renewal; Site Licences are presently renewed annually for the first three years. After that, they are renewed and valid for two years.  The third cycle is that once the first seven years have passed, they are valid for three years.

Fees; There is no government fee for obtaining a Site Licence or for renewing one.

We have simplified the process of completing a site licence application and obtaining a site licence from the Natural and Non-Prescription Health Products Directorate (NNHPD) into eight steps.

More detail on each follows:

Step 1:

We sign a non-disclosure agreement with you (yours or ours) so that you can be assured that anything we discuss remains strictly confidential. Eventually, some of the information will be part of the application process to Health Canada but they are the only people outside of ourselves to which anything will be disclosed.

Step 2:

You identify who your Canadian importer is – and if they do not already have a site licence, we work with the company to obtain one. This involves proving GMP compliance, usually through a Quality Assurance Report providing Standard Operating Procedures (SOPs) and executed records. If your importer does not have SOPs, we can provide them for you.

Step 3:

You identify any other entities that will deal with the product (i.e. foreign manufacturers, foreign warehouses, fulfillment centres, etc.). Each of these will have to be annexed onto the importer’s site licence so that Health Canada can ensure the product has been manufactured/packaged/labelled/stored in GMP-compliant facilities.

Step 4:

Once we understand your site licensing requirements, we will send you an all-inclusive, comprehensive written quotation for the work required. There are no hidden or additional charges. What we quote is all that you will pay.

Step 5:

Once the quote is accepted, we compile, complete, and submit the application to NNHPD for assessment.

Step 6:

We will then issue you an invoice for the amount quoted.

Step 7:

We work with NNHPD and your sites to answer any questions raised during the assessment of the site licence.

Step 8:

You get a site licence. You can now perform the licensed activities (such as manufacturing, packaging, or labelling) and/or ship any licensed products* from your manufacturing/warehousing sites to your Canadian importer.

*learn more about product licensing requirements here

As the authority of Health Canada ends at our borders, they cannot issue licences to companies outside of Canada. However, they do have the authority to make certain that the products entering Canada comply with our regulatory requirements. Health Canada accomplishes this by having the “foreign” company supply appropriate documentation (similar to what is required to receive a Site Licence).

When these documents are deemed compliant with good manufacturing practices, a Foreign Site Reference Number (FSRN) is granted by the NNHPD. Then, that company can, and must, be annexed onto your Canadian importer’s Site Licence. The “foreign” company is annexed and the natural products are allowed into Canada via that importer. Once annexed, there is no limit on how many shipments of licenced products* can come into Canada.

In summary, the following is required:

1. FSRN - applied for by a foreign company

2. Annexation to a site licence of a Canadian Importer

*licensed products are natural health products that have received a natural product number/NPN.