How to Get a Health Canada Site Licence for Supplements: Step-by-Step Guide
A Health Canada site licence is the authorization you need to manufacture, package, label or import natural health products (NHPs) for sale in Canada. To get one, you submit a Site Licence Application form to Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD), together with evidence that every site involved meets Canadian Good Manufacturing Practices (GMP).
This guide walks through who needs a licence, what to prepare, how the application works, how long it takes and what it costs. It is written for supplement brand owners, importers and entrepreneurs without a regulatory background.
Quick Answer: You need an NHP site licence if you manufacture, package, label or import supplements for sale in Canada. Health Canada's published service targets are 30 business days when every site has pre-cleared GMP evidence and 60 business days when you rely on a Quality Assurance Report (up to 90 for 10 or more sites). Health Canada does not currently charge an application fee for NHP site licences.
What Is a Health Canada Site Licence and Who Needs One?
Under Part 2 of the Natural Health Products Regulations, no one may manufacture, package, label or import an NHP for sale without a site licence. The licence lists your activities, your Canadian buildings and, for importers, each foreign manufacturing site you source from.
You need a site licence if you:
Make or process finished natural health products in Canada
Package or label NHPs in Canada
Import finished NHPs for sale, including when goods ship straight to a retailer or you sell your own imported products online
You generally do not need one if you only distribute products that someone else imported, or if you only handle raw materials that are not ready for consumer use. Distributors must still follow GMP. Testing labs and health care practitioners compounding for an individual patient are also exempt.
Site licence vs. product licence (NPN)
Product licence (NPN) | Site licence | |
What it approves | One specific product: formula, dose, claims and label | Your Canadian business activities and buildings |
Who holds it | The product licence holder | The manufacturer, packager, labeller or importer |
GMP evidence | Not the focus of the application | Required for every site |
Current government application fee | None currently charged | None currently charged |
Most brands need both. Our NPN licensing service covers the product side, while the rest of this guide focuses on the site licence.
What You Need Before You Apply
Section 28 of the Regulations sets out what a complete application contains. Gather these items first:
Site Licence Application (SLA) form, listing your contact details, the activities you propose, the address of each building and whether you work with sterile dosage forms
GMP compliance evidence for each site, including every foreign site if you import
Designated Party Authorization (DPA) form, if a consultant files on your behalf
A cover letter stating whether each site's evidence is pre-cleared or a Quality Assurance Report (QAR), so the file is reviewed under the right service standard
Accepted GMP evidence
Evidence type | How long it stays valid |
Drug Establishment Licence (DEL) | 3 years from the inspection date |
GMP certificate from a PIC/S or Mutual Recognition Agreement authority | 3 years from the inspection date |
NSF/ANSI 173 (Section 8) certificate, plus testing and stability information | 3 years from the audit date |
Foreign Site Reference Number (FSRN), for overseas sites | 1 or 3 years, depending on the evidence behind it |
Quality Assurance Report (QAR) by your quality assurance person | 1 year from completion |
Certificates and an FSRN are called pre-cleared evidence and move through the fastest review stream. A QAR is a self-assessment against GMP, so it takes longer. If you are unsure your site would pass, a GMP audit before filing can expose gaps while they are still cheap to fix.
How to Get a Health Canada Site Licence: Step by Step
Decide your activities and buildings. List what you will do (make, package, label, import) and the address of every building, including third-party warehouses where imported products are stored.
Choose your GMP evidence. Check whether each site has a valid certificate or FSRN. If not, your quality assurance person must complete a QAR after an on-site verification.
Prepare the SLA form, DPA form and cover letter. Make sure names, addresses and signatures match across every document. Missing forms or signatures count as administrative deficiencies and can lead to rejection.
Submit to the NNHPD. Health Canada encourages secure electronic filing through epost Connect, which requires enrolment as a Trading Partner. Confirm the current submission instructions on Canada.ca before you file.
Watch for the acknowledgement. Complete applications are acknowledged within 5 business days, and the review clock starts from that acknowledgement.
Answer any Information Request Notice (IRN). Health Canada usually allows about 15 business days to respond, and it aims to send one consolidated request.
Receive your licence. Health Canada issues a site licence number, and licence holder details are posted on its public list.
If you import, remember the product side too. Product licence holders must give Health Canada the importer's site licence number before they start selling, so run both applications in parallel. Our guide on importing supplements into Canada shows how the pieces fit together.
How Long Does a Site Licence Take and What Does It Cost?
Timelines
Application type | Health Canada target |
Administrative check and acknowledgement | 5 business days |
Every site has pre-cleared GMP evidence | 30 business days |
1 to 9 sites, QAR used for one or more | 60 business days |
10 or more sites, QAR used for one or more | Up to 90 business days |
Notification of a change | 15 business days |
These are targets, not guarantees. The clock pauses while Health Canada waits for your IRN response, and heavy application volumes can add delays, so build a buffer into your launch date.
Government fees vs. professional costs
Health Canada currently relies on public funding for NHP regulatory services and does not charge an application fee for a site licence. It has proposed cost recovery fees, revised in March 2024, but they are not in force, and final fees would be published in the Canada Gazette, Part II first. Always check Canada.ca before filing.
Your real costs are professional and operational: preparing SOPs and the QAR, GMP audits or certificates for suppliers, finished-product testing and stability data, and consulting help. These vary widely, so ask for a scoped quote instead of relying on averages.
Renewals, Amendments and Notifications
A site licence expires on the first anniversary of its issue date unless renewed. Submit your renewal request at least 30 days before expiry, and allow more time for the review stream you fall into. After the first year, renewal periods run one, two or three years, depending on how long you have held the licence.
Some changes need an amendment approved before you act: new activities, new buildings or storage locations, a move to sterile dosage forms, or adding a foreign site. Other changes, such as a new address or a substantial change to equipment or procedures, need a notification within 60 days.
Common Mistakes to Avoid
Relying on a supplier saying it is "GMP certified" without current evidence that covers every NHP activity and building
Listing a warehouse address on the application that differs from the one on supporting documents
Forgetting the DPA form when a consultant files for you
Submitting a renewal too close to expiry, then being unable to operate
Starting a new activity or adding a building before the amendment is approved
Frequently Asked Questions
Do I need a site licence to sell supplements on Amazon Canada?
It depends on your role. If you import the products yourself, you need a site licence. If you only buy from a licensed Canadian importer and resell, you do not need one, but each product still needs an NPN.
Can my overseas manufacturer get a Canadian site licence?
No. Site licences cover activities in Canada. Foreign manufacturers, packagers and labellers can apply for an FSRN, which acts as pre-cleared GMP evidence for your importer application.
Do I need a site licence before I apply for an NPN?
No, the two applications can run in parallel. You will need your site licence in place before you import and sell the product.
Can a consultant file the application for me?
Yes. A designated party can file when you submit a Designated Party Authorization form with each application.
Need Help with Your Site Licence Application?
Our team prepares the documents, reviews your GMP readiness, files with Health Canada and responds to its questions for you. Explore our site licence service, or tell us about your business and we will outline the fastest compliant route with a clear, all-inclusive quote.
Official sources: Site Licensing Guidance Document · NHP cost recovery · Natural Health Products Regulations
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