Site Licensing Forms

All businesses in Canada that wish to manufacture, package, label or import natural health products for sale must hold a current site licence.

A site licence gives the licensee the authorization to manufacture, package, label or import natural health products in Canada. These activities must be carried out according to the good manufacturing practices outlined in part 3 of the Natural Health Product Regulations.

On this page

• How to interact with us electronically
• Harmonized Site Licence and FSRN Application Form
• Additional forms

How to interact with us electronically

As of November 30, 2020, the Natural and Non-prescription Health Products Directorate (NNHPD, formerly the Natural Health Products Directorate) no longer accepts paper-based Site Licence and FSRN submissions sent by courier or mail. Applicants will use ePost connect to submit all site licence and FSRN submissions.

This secure online system allows a company to:

• submit confidential documentation directly to the NNHPD by email
• track its transactions

The guidance on how to interact with the NNHPD electronically provides a summary for trading partners using the online system. A trading partner is a company or private business that has gone through the steps of validating its status with the NNHPD.

• Trading Partner Agreement (PDF version - 997KB)
• Trading Partner Profile

Before you apply for a site licence (SL) or foreign site reference number (FSRN), Health Canada must assign a company code (a number) for your company.

• If you do not already have a company code, email us at nnhpd.consultation-dpsnso@hc-sc.gc.ca and put in the subject line “Request for a company code”.
• In the body of your email, include the company information that you will be using to complete your site licence application form (Web SLA), including company name and address, contact information and senior official (for example, chief executive officer or director).

Harmonized Site Licence and FSRN Application Form

Web-based form

Released on November 12, 2020, the Harmonized Site Licence and FSRN Application Form (version 1.0) allows users to fill a site licence application or foreign site reference number (FSRN) application online. The completed application form is saved as an .html file that must be sent to the NNHPD as part of the submission package.

System requirements

For best results, we recommend using the Harmonized Site Licence and FSRN Application form in Firefox 54+ or Chrome 60+. JavaScript must be enabled in your browser.

Instructions

Instructions for completing the form can be found in the form itself:

• Harmonized Site Licence and FSRN Application Form

Additional forms

Please read the instructions for completing the following forms first.

• Quality Assurance Report Form (QAR) (PDF fillable/saveable, 815 K), with instructions
• Supplementary Quality Assurance Report (SQAR) Form for Homeopathic Medicines (HM) (PDF fillable/saveable, 481 K), with instructions
• Summary of Net Changes Form (SNC) (PDF fillable/saveable, 381 K), with instructions
• Designated Party Authorization Form
• Foreign Site Reference Number Authorization Form