Who needs an NHP site licence is usually the first regulatory question a new brand owner asks, and the answer surprises most of them. Many founders assume every company with its name on a bottle needs one. In reality, the requirement follows the activity, not the brand. This guide maps the four licensed activities, shows where brand owners, importers and distributors fit, and flags the common traps that create compliance gaps.
Key Takeaways
- A site licence covers activities at a physical site; a product licence (NPN) covers the product itself.
- Manufacturing, packaging, labelling and importing for sale each require a site licence.
- A brand owner who outsources all four activities to licensed sites usually doesn't need its own site licence.
- Relabelling or repackaging in your own warehouse counts as a licensed activity.
- Distributors and retailers selling finished, labelled products don't need a site licence.
Site Licence vs Product Licence: Two Separate Approvals
Canada's Natural Health Products Regulations set up two separate licensing tracks. The product licence, which carries the eight-digit NPN, authorizes a specific product for sale. The site licence, by contrast, authorizes a specific building to carry out specific activities. Health Canada assesses each one on its own terms.
Here's what that means in practice: holding an NPN does not let you make the product, and holding a site licence does not let you sell an unlicensed product. Most brands need a product licence for every SKU. However, far fewer need a site licence of their own. For the product side, see the guide to the NHP product licence in Canada.
Who Needs an NHP Site Licence? The Four Licensed Activities
So who needs an NHP site licence? Under the regulations, any company that manufactures, packages, labels or imports a natural health product for sale in Canada needs one. The licence lists which of these activities each site performs. As a result, one company can hold a licence for labelling only, while another covers all four.
Each licensed site must also meet the Good Manufacturing Practices in Part 3 of the regulations. Those requirements cover premises, equipment, personnel, sanitation, records and more. The post on NHP site licence GMP requirements walks through them in detail.
Brand Owners: When You Need an NHP Site Licence
This is where most brands run into trouble. A typical private label brand owner designs the formula, holds the NPN and markets the product. Meanwhile, a contract manufacturer handles manufacturing, packaging and labelling at its own licensed site. In that model, the brand owner usually doesn't need a site licence at all, because it performs none of the four activities itself.
However, small operational choices can change the answer. For example, some brands buy pre-filled, unlabelled bottles and apply their own labels to save money. That step is labelling, so the brand now needs an NHP site licence for its premises. Likewise, a brand that decants bulk tincture into retail bottles is packaging, even at small volumes.
The practical implication: map every physical step between raw material and finished retail unit before you launch. Then confirm that a licensed site performs each one. If any step happens in your own space, budget for a site licence and the GMP obligations that come with it.
Even without a site licence, the product licence holder carries real responsibility. The NPN holder must make sure every site in the chain holds the right licence. The holder also handles adverse reaction reporting and recalls. In short, outsourcing production doesn't outsource accountability.
Importers: Site Licence Rules for Products Made Abroad
Importing is the activity brand owners most often overlook. If your product comes from outside Canada, the Canadian company that brings it in for sale needs an NHP site licence that covers importing. That rule applies even when the finished product arrives fully labelled and ready for shelves.
Foreign manufacturing sites don't receive Canadian site licences. Instead, the importer must show that each foreign site meets Canadian GMP requirements, usually through inspection reports or other evidence that Health Canada accepts. The short version: importing shifts more of the compliance burden onto you. That's one reason many brands weigh a domestic partner against an overseas one, a question the post on North American herbal extract suppliers explores.
Distributors, Retailers and Online Sellers
No one who simply sells a finished, properly labelled product needs an NHP site licence. Distributors, wholesalers, health food stores, clinics and online retailers all fall into this group. Similarly, a third-party logistics warehouse that only stores and ships sealed, labelled units typically sits outside the four activities. The guide to natural health product fulfillment covers the 3PL decision in more depth.
That said, the line moves the moment a seller opens a case and changes the product. Adding a French sticker, bundling bottles into a gift set with a new outer label, or splitting a bulk pack all count as labelling or packaging. So before a retailer or 3PL offers kitting services, it should confirm whether those services trigger a licence.
Choosing a Partner With the Right Site Licence
Whichever model you choose, verify your manufacturer's site licence before you sign. Specifically, ask which activities the licence covers and when it expires. A site licensed only for manufacturing, for example, can't legally package or label your product. It also helps to understand what Health Canada looks for on site, which the guide to NHP inspection preparation explains.
Ultimately, the question of who needs an NHP site licence comes down to one test: who does the physical work, and where? Get that map right early, and you avoid relabelling surprises, import delays and inspection findings later. If you're planning a new herbal line, explore our manufacturing services or get in touch to talk through your production model.
Published: October 1, 2026