Why NHP Product Licence Applications Get Rejected — And What Most Applicants Miss

About 3 in 10 natural health product licence applications submitted to Health Canada arrive with at least one problem significant enough to generate a Request for Additional Information before technical review even begins. That figure isn’t published prominently on any government website — it comes from talking to consultants and manufacturers who’ve been through the process more than once. And it understates the real friction: because RAIs pause the clock, a single deficiency letter can push your timeline from 12 months to 18 or more.

If you’re preparing a product licence application (PLA) under Canada’s Natural Health Products Regulations (SOR/2003-196), the good news is that most rejections and deficiencies are predictable. They cluster around a handful of consistently misunderstood requirements. Understanding them before you file is worth far more than scrambling to answer a Request for Additional Information six months in.

Why the Screening Stage Catches More Applications Than You’d Expect

Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) screens every incoming PLA for administrative completeness before it moves to substantive review. This isn’t a deep technical assessment — it’s a checklist review. But applicants still fail it with surprising regularity.

The most common administrative triggers: missing or unsigned authorization forms, incorrect product type classification (Natural Product Number versus Drug Identification Number, or NHP versus homeopathic medicine), and fee discrepancies. Since Health Canada shifted to its Cost Recovery model, processing fees have been updated, and an incorrect fee — even by a small amount — can result in a returned submission. Always verify the current schedule on the NNHPD website within 60 days of your planned filing date.

There’s another issue we see frequently in first-time submissions: applicants use outdated form versions. Health Canada updates its electronic PLA forms through the Natural Health Products Online Solution (NHPOLS) system, and older versions sometimes omit fields for recently required data elements. If you’re working from a template that’s more than 18 months old, verify it still matches current requirements before building your file around it.

Evidence Gaps Are the Single Biggest Driver of Substantive Rejections

Once an application clears screening, the most frequent reason for a formal deficiency — or outright rejection — is inadequate evidence supporting the health claims on the label. This is where the Natural Health Products Regulations get technical, and where most applicants underestimate what Health Canada actually needs to see.

Under the NHPR, evidence requirements follow a tiered framework. Traditional-use claims — defined under section 2 as use recognized in a pharmacopoeial, herbal, or traditional reference for at least 50 consecutive years, with at least 15 years in a Western tradition — carry a lower evidentiary bar than non-traditional or structure/function claims. But “lower bar” doesn’t mean no bar. A traditional-use claim for an herbal ingredient still requires a recognized reference source — and not all references Health Canada accepts are equivalent.

The NNHPD publishes a list of accepted compendial sources, including the British Herbal Pharmacopoeia, the WHO Monographs on Selected Medicinal Plants, ESCOP Monographs, and the American Herbal Pharmacopoeia. The problem is that applicants sometimes cite sources not on that list, or cite accepted sources for claims those sources don’t actually support. An accepted reference that doesn’t explicitly validate the proposed claim, dosage, and intended population will generate a deficiency. We’ve seen applications where the referenced monograph supported a claim for adults, but the label included a paediatric sub-population — the claim failed review even though the reference itself was otherwise recognized.

Non-traditional claims, based on clinical evidence rather than traditional use, require a higher level of support: randomized controlled trials, systematic reviews, or peer-reviewed meta-analyses, matched specifically to the ingredient, dose form, dose amount, and duration proposed on your label. One clinical study rarely suffices on its own. Health Canada expects the submitted evidence to directly address each element of the proposed claim wording — not just the ingredient category in general.

Natural Health Product Labelling Issues That Trigger Automatic Deficiencies

Labelling is assessed as a separate layer, and it generates deficiency requests independently of the evidence file. The requirements under sections 93 through 103 of the NHPR are detailed, and several of them catch first-time applicants off guard.

Bilingual requirements: All text on the principal display panel — including the product name, dosage form, and net quantity — must appear in both English and French under the Consumer Packaging and Labelling Regulations. This isn’t unique to NHPs, but the NNHPD enforces it strictly. Approximately 15% of deficiency letters issued to first-time applicants in small-batch categories include a language compliance flag. Many English-market manufacturers simply underestimate how consistently this gets flagged.

NPN placement and format: The Natural Product Number must be displayed as “NPN XXXXXXXX” once the licence is issued, with type size consistent with overall label readability. Pre-approval mock labels submitted as part of the PLA must include a clearly labelled placeholder for this field — even though the number won’t exist until after approval.

Recommended conditions of use alignment: The label must include recommended use or purpose, recommended dose (including route of administration and duration), risk information (cautions, warnings, contra-indications, and known adverse reactions), and correct placement for lot number and expiry date. Critically, the claim wording on your label mock-up must match exactly what you’ve submitted in the application evidence section — word for word. Paraphrasing a claim between the label mock-up and the evidence summary is one of the most avoidable ways to generate a deficiency, and it’s more common than it should be.

How to Respond to an RAI Without Making It Worse

If you receive a Request for Additional Information, you typically have up to 6 months to respond, depending on the RAI type. Failure to respond within that window results in the application being deemed abandoned — you’ll need to re-file and pay again.

The most common mistake we see in RAI responses is over-submission. Applicants panic, compile everything they can find related to the ingredient or claim, and send Health Canada a 200-page package. That’s usually counterproductive. Reviewers are looking for targeted responses to specific deficiency points. A well-structured RAI response addresses each concern in numbered order, provides only the evidence directly responsive to the stated issue, and includes a brief cover letter explaining precisely what has changed in the submission.

If Health Canada’s concern is about claim wording, don’t just add more evidence — revise the claim language to match what your evidence actually supports. A narrower, better-supported claim will clear review faster than a broad claim with a dense evidence file that reviewers have to interpret themselves.

For applications involving multiple health claims or a complex ingredient list, consider requesting a pre-submission meeting with the NNHPD before filing. Health Canada does offer pre-submission consultations, and while the wait time can run 8 to 12 weeks, the feedback often prevents multiple RAI cycles downstream. For manufacturers with 5 or more products in development, that time investment is almost always worth it.

What a Solid First Submission Under Canada’s Natural Health Products Regulations Actually Looks Like

Before any PLA leaves your desk, it should pass an internal review against three criteria. Is every proposed claim directly supported by an accepted compendial reference or a clinical evidence package that addresses dose, population, duration, and endpoint? Does the label mock-up contain every mandatory element under sections 93–103 of the NHPR, in both official languages? And have you verified the current fee schedule and form version within the last 60 days?

That’s not an exhaustive checklist — a full pre-submission audit also covers ingredient safety data, non-medicinal ingredient acceptability, the manufacturing attestation under Part 3 of the NHPR, and site licensing status. But those three questions catch the majority of deficiencies before Health Canada ever sees the file.

Regulatory timelines in Canada are already long. Health Canada’s standard processing target for PLAs runs into the hundreds of business days, and the backlog in the NNHPD has stretched real-world timelines further in recent years. Getting the submission right the first time isn’t just tidier — for most manufacturers, it’s the difference between a product launching in Q2 or sliding to Q4 of the following year.

---

Written by Nour Abochama, Quality & Regulatory Advisor, Androxa. Learn more about our team

Talk to our team about Health Canada compliance Contact us

Related from our network

• NHP Ingredient Analytical Testing & COA Services — ISO 17025–accredited third-party testing for potency, identity, and contaminants to support your Canadian product licence application
• EU Cosmetics and Borderline NHP Regulatory Strategy — Guidance on EU 1223/2009, REACH compliance, and market-entry requirements for products sold across both European and Canadian markets