Harmonized Site Licence and FSRN Application form

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General information

The web-based harmonized site licence and foreign site reference number (FSRN) application form (web SLA) is designed to be completed online and saved on the applicant's workstation.

In order to complete the form, you must have a company code (a 5-digit number). If you do not already have a company code, email the Natural and Non-Prescription Health Products Directorate (NNHPD) at hc.nnhpd-dpsnso.sc@canada.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, address, contact information and name of the senior official.

The most current version of the web SLA must be used for all site licence and FSRN submissions. Upon completion of the web SLA, submit the saved .html file to the NNHPD electronically as part of a complete submission package (for more information, consult the Guidance Document on How to Interact with the NNHPD Electronically and Site Licencing Guidance Document).

Updated Web SLA:

The web SLA update on July 24, 2021 (version 2.0) includes the following changes:

  • Addition of a COVID-19 Site Licence Transition pathway

  • Addition of a Summary page

COVID-19 Interim Site Licence Transition

In March 2020, the Natural and Non-Prescription Health Products Directorate (NNHPD) introduced interim measures to enable expedited site licensing for alcohol-based hand sanitizers to address the shortage of these products and meet public health recommendations. On July 13, 2020, NNHPD stopped accepting new applications for an interim COVID-19 site licence and advised that it would provide 60-day advance notice of when the interim COVID-19 site licences that had been issued up until July 13, 2020 would no longer be valid. From December 2020 to February 2021, NNHPD surveyed all interim COVID-19 SL holders to inform the transition plan.

In July of 2021, NNHPD communicated to all interim COVID-19 site licence holders (licences denoted by the prefix "COV####") that they are required to submit a complete application for a site licence under Part 2 of the Natural Health Products Regulations (NHPR) by September 30, 2021 in order to continue activities beyond that date.

Those who do not apply by September 30, 2021 at 11:59pm EST shall be required to cease manufacturing, packaging, labelling and/or importing activities with respect to NHPs by that date. Additionally, should a refusal notice be received at any point during the application process, activities related to manufacturing, packaging, labelling and/or importing of NHPs must immediately cease.

The NNHPD is no longer accepting amendments to interim COVID-19 SLs.

How do I transition from an interim COVID-19 SL to a regular SL?

Step 1: Review the communication sent to you in July of 2021, which outlines the requirements and process to follow for the transition.

Step 2: COVID-19 SL holders who wish to transition to a regular Site Licence are required to complete the web SLA form, noting that you must select "COVID-19 SL Transition" on the first page.

Step 3: Applications will be required to demonstrate compliance with the Good Manufacturing Practices (GMPs) outlined in Part 3 of the NHPR. You are encouraged to familiarize yourself with the requirements as detailed in the Good Manufacturing Practices Guidance Document, the Quality of Natural Health Products Guide and the Antiseptic Skin Cleansers (Personal Domestic Use) monograph.

Step 4: Upon completion of the web SLA form and all supporting documentation, applicants shall save the web SLA form as an .html file and submit it, along with all required documentation, via ePost Connect. Consult Appendix 1, Step 4 of the bulletin to COVID-19 SL holders sent in July 2021 for specific instructions on submitting via ePost Connect.

Step 5: Monitor your email, including junk mail, for a notification from the ePost Connect System. This will be the means through which you will be sent future communication.

  • An " Acknowledgment of Receipt" or "Notice of Refusal" will be sent through ePOST within 30 days confirming that the application has been received or rejected for being incomplete. If you do not receive an ePost message within 30 days, contact the NNHPD at hc.nnhpd-dpsnso.sc@canada.ca.

Step 6: If your application is refused, any activity that had been authorized under the interim COVID-19 SL must cease immediately. The communication sent in July of 2021 outlines the refusal criteria that are being applied as part of the transition. Health Canada may undertake additional compliance actions to ensure that activities have ceased, as needed.

  • Activities may continue under the interim COVID-19 SL until a regulatory decision is issued by the NNHPD. As such, status update requests will not be provided.

Start your application

Version: 2.0.0
Date modified: