Natural Health Product (NPN and Site Licence) Readiness
Hold the right product and site licences, have your QA person approve each lot and report serious reactions within 15 days.
In Short
- QA person approves every lot.
- Serious reactions: 15 days.
- Keep lot records 1 year past expiry.
The Dietary Supplement Operations Guide
What the label says. What the batch proves.
- The rules and who decides
- Specification to finished batch
- Test, review, investigate
We ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.
UltimateFree guide
The Dietary Supplement Operations Guide
What the label says. What the batch proves.
In Canada, natural health products such as vitamins, minerals, herbal remedies and many topical products are governed by the Natural Health Products Regulations, SOR/2003-196, current to 21 September 2026 on the Justice Laws site. They need a product licence to be sold and a site licence to be manufactured, packaged, labelled or imported. This guide covers licensing, Part 3 GMP, reporting and labelling. Orientation, not legal advice. Sources checked 4 Oct 2026.
Two licences: product and site
Section 4(1) says no person shall sell a natural health product unless a product licence has been issued for it; the licence carries the product number shown on the label. Section 27(1) says no person shall manufacture, package, label or import a natural health product for sale unless they hold a site licence for that activity and conduct it in line with Part 3.
More on two licences: product and site
Sales must stop during a suspension or after cancellation. Plan which party holds each licence in a contract-manufacturing arrangement and record it, because each licence carries its own duties.
Quality assurance person and lot approval
Section 51(1) requires every manufacturer, packager, labeller, importer and distributor to have a quality assurance person responsible for assuring quality before the product is made available for sale, with relevant training, experience and technical knowledge. That person must approve materials before use and methods before implementation, and section 51(4) requires every lot or batch to be approved by a quality assurance person before sale.
Worked Example: Lot NH-0733 Path to Sale
- ReceiptRaw materials approved for use by QA person (s.51(2))
- ProductionMade to master production document v6
- TestingFinished lot results recorded
- ReleaseQA person approves lot before sale (s.51(4))
- Expiry + 1 yearEarliest disposal of lot records (s.58)
More on quality assurance person and lot approval
Returned product needs approval before resale. Complaints about quality must be investigated and recorded, with corrective action where necessary. These are human approvals.
Stability and Records
Section 52 requires manufacturers and importers to determine the period during which the packaged product keeps its purity, physical characteristics, and medicinal ingredient quantity and potency under recommended storage, or room temperature if none is given. Section 53 lists manufacturer records, including the master production document, the ingredients in each lot, and testing of raw materials and finished lots.
More on stability and Records
Packagers, labellers, importers and distributors have their own lists. Section 58 requires lot-related records to be kept for one year after the product's expiry date.
Adverse Reactions and Recalls
Section 24(1) requires a licensee to send a case report within 15 days of becoming aware of each serious adverse reaction occurring in Canada, and of each serious unexpected adverse reaction occurring inside or outside Canada. Section 24(2) requires an annual summary report with a concise and critical analysis of adverse reactions.
Reporting Clocks
| Event | When | Source |
|---|---|---|
| Serious adverse reaction in Canada | 15 days after awareness | s.24(1)(a) |
| Serious unexpected reaction anywhere | 15 days after awareness | s.24(1)(b) |
| Recall started | Section 62 information within 3 days | s.25 |
| All reactions in Canada | Annual summary report | s.24(2) |
- Serious adverse reaction in Canada
- When
- 15 days after awareness
- Source
- s.24(1)(a)
- Serious unexpected reaction anywhere
- When
- 15 days after awareness
- Source
- s.24(1)(b)
- Recall started
- When
- Section 62 information within 3 days
- Source
- s.25
- All reactions in Canada
- When
- Annual summary report
- Source
- s.24(2)
More on adverse Reactions and Recalls
Section 25 requires a licensee that starts a recall to provide the information listed in section 62 within three days of starting it. Qualified people decide whether a case is serious or unexpected; software can keep intake dates and case history.
Labels: principal display panel and Product Facts
Section 93 requires the brand name, product number, dosage form, the words sterile and stérile where applicable, and net amount on the principal display panel. Section 93.1 requires the licence holder or importer, route of administration, lot number, expiry date and a Product Facts or Drug Facts table in English and French, with set headings in a set order.
More on labels: principal display panel and Product Facts
Section 95 requires security packaging for products to be ingested, inhaled, inserted or used in the eye, with exceptions. The transition provisions of the 2022 labelling amendments were not opened, so confirm which rules apply to each product now.
Questions
Do we need both a product and a site licence?
A product licence is needed to sell (section 4). Manufacturing, packaging, labelling or importing for sale needs a site licence for that activity (section 27).
Who approves each lot?
A quality assurance person approves every lot or batch before it is made available for sale (section 51(4)).
How long are lot records kept?
One year after the expiry date of the product the record relates to (section 58).
When is a serious adverse reaction reported?
Within 15 days after the licensee becomes aware of it, for serious reactions in Canada and serious unexpected reactions anywhere (section 24(1)).
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
Canada NNHPD: NPN, Monographs, Site Licence and Claims
Canada Cannabis Regulations (SOR/2018-144): GPP, Testing, Recall and Labels
Canada Medical Devices Regulations (SOR/98-282) Readiness
Canada Drug GMP Readiness: Food and Drug Regulations Part C, Division 2
Canada Supermarket Supplier Standards: Readiness Guide
China Health Food Readiness: Blue Hat Registration and CBEC