On June 15, 2026, Health Canada’s Natural and Non-prescription Health Products Directorate published a bulletin on finished product specifications. The headline in most industry posts was a relief: less paperwork in the licence application.
That is accurate. It is also easy to misread as “specifications matter less now”. I think the opposite is true.
What changed
According to the bulletin, as reproduced by Cosmetics Alliance Canada:
- Effective June 25, 2026, applicants and licence holders no longer submit finished product specifications (FPS) with Class II and Class III product licence applications and amendments. This matches Class I, which already did not require them.
- Changes made solely to an FPS no longer need an amendment or a notification.
- Licence holders are still expected to maintain FPS that comply with the current Quality of Natural Health Products Guide.
- Health Canada can request an FPS at any time, including through an Information Request Notice during a review, for example for cannabis-containing products.
- The change “does not impact existing Natural Health Products Good Manufacturing Practices (GMP) requirements.”
I have not found the bulletin as its own page on canada.ca, so I am quoting the association’s reproduction. Check the original wording with Health Canada before relying on any one sentence.
What did not change: GMP
The NHP GMP guide (GUI-0158, version 4, implemented March 4, 2026) sets the specification requirements, and none of them depend on whether the FPS was submitted (GUI-0158 v4, section 6.2).
Section 44 of the regulations requires the specifications to contain:
- detailed information on purity, with purity tolerances
- for each medicinal ingredient, its quantity per dosage unit and identity, with tolerances
- potency, with tolerances, if potency is shown on the label
- a description of the test methods
The specifications and every change must be approved by a quality assurance person. And every manufacturer and importer must have written specifications for all finished products, in accordance with the Quality of NHPs Guide, plus written procedures for finished product testing (GUI-0158 v4, section 6.2).
One point to watch. The GMP guide, issued in September 2025, lists specification changes that need a licence amendment, such as removing a test method or widening a tolerance. The June 2026 bulletin says FPS-only changes no longer need an amendment. I would not assume how those two fit together for a specific change. Ask Health Canada or your regulatory consultant before you widen a tolerance or drop a test.
The tolerances your results are read against
Health Canada’s FPS form user guide gives the limits a finished NHP is normally tested against (Table 1):
| Test | Tolerance |
|---|---|
| Quantity of most medicinal ingredients, vitamins and minerals | pharmacopoeial limits, or 80–120% of label claim |
| Enzymes | 80–150% |
| Probiotics | at least 80% of label claim at end of shelf life |
| Lutein | 90–130% |
| Identity | conforms to reference material (probiotics: phenotype plus genotype) |
| Microbial purity, most products | USP, BP or Ph. Eur. limits |
These do not move because the FPS is no longer submitted.
Why the lab matters more now
Before June 2026, a Class II or III FPS went to a reviewer with the application. A reviewer could notice a missing identity test, a tolerance outside the norm, or a method that could not measure what the specification claimed. That check no longer happens at submission.
The specification still has to be right. So the people who catch a problem are now mostly the licence holder’s own QA person and the lab doing the testing. From the lab side, these are the questions I would ask of any NHP specification:
- Is every medicinal ingredient covered for both identity and quantity? A multi-ingredient product can drop an ingredient from the test list without anyone noticing.
- Can the identity method tell this ingredient apart from its known adulterants? For some botanicals, a single method can be fooled on purpose. I wrote about synthetic curcumin passing HPLC.
- Is the method validated for this matrix? A method for a capsule powder may not work for a tincture or a gummy.
- Does the tolerance match Table 1 or a pharmacopoeia, and is the reason written down if it does not?
- Do the stability results support the expiry date? The quantity has to be within tolerance at the end of shelf life, not only at release. See real-time stability under GMP v4.
Sources
- NNHPD Bulletin 11, Expectations for finished product specifications, 15 June 2026, as reproduced by Cosmetics Alliance Canada. Original not located on canada.ca.
- Health Canada. Good manufacturing practices guide for natural health products (GUI-0158), version 4, issued 4 September 2025, implemented 4 March 2026, section 6.2.
- Health Canada. Finished product specifications form user guide, Table 1.
This is a summary of public guidance, not regulatory advice for any product. If you are reviewing your own specifications now that no reviewer checks them at submission, tell me the product type on LinkedIn and I will tell you what I would check first.
Common questions
- Do I still need finished product specifications for an NHP?
- Yes. Health Canada's bulletin says licence holders are still expected to maintain FPS that comply with the Quality of Natural Health Products Guide, and the NHP GMP guide requires written specifications for purity, quantity, identity and potency for every finished product, approved by the quality assurance person.
- When did Health Canada stop requiring FPS with product licence applications?
- Effective June 25, 2026, applicants no longer submit FPS with Class II and Class III product licence applications and amendments. This aligns them with Class I applications, which already did not require FPS.
- Can Health Canada still ask for my finished product specifications?
- Yes. Health Canada retains the authority to request an FPS at any time, including through an Information Request Notice during an application review, for example for cannabis-containing products.
- What must an NHP specification contain?
- Section 44 of the Natural Health Products Regulations requires information on purity with purity tolerances; for each medicinal ingredient, quantity per dosage unit and identity with tolerances; potency with tolerances if potency is on the label; and a description of the test methods. The specifications and every change must be approved by a quality assurance person.
- What tolerance applies to the quantity of a medicinal ingredient in an NHP?
- Health Canada's FPS user guide lists pharmacopoeial limits or, where there are none, 80% to 120% of label claim for most ingredients, vitamins and minerals. Enzymes are 80% to 150%, and probiotics must be at least 80% of label claim at the end of shelf life.