Do You Still Need Finished Product Specs for NHPs in Canada?

In June 2026, Health Canada quietly changed one line in the natural health product application process. Through NNHPD Bulletin No. 11, the Natural and Non-prescription Health Products Directorate told industry that it no longer expects a finished product specification, or FPS, to be filed with Class II and Class III product licence applications and their amendments. For a busy regulatory team, that reads like good news and one less document to prepare. It is not that simple. The obligation to build, validate and maintain a compliant FPS has not changed at all. Only the moment when Health Canada looks at it has moved.

This article explains exactly what changed, what did not, and why treating the FPS as optional is one of the most expensive misreadings a natural health product company can make in 2026. If you hold or are applying for an NHP product licence, the short answer is this: you still need a finished product specification, it still has to be defensible, and Health Canada can now ask to see it at a moment when you have far less room to fix it.

The short answer

Health Canada removed the expectation to submit an FPS with Class II and Class III NHP product licence applications, effective 25 June 2026. It did not remove the legal requirement to have one. Under section 44 of the Natural Health Products Regulations, every NHP available for sale in Canada must comply with the specifications established for it. Your FPS still has to exist, still has to be scientifically justified, and must be produced on request. The evidence burden simply shifted from pre-market review to post-market inspection.

What changed under NNHPD Bulletin No. 11

NNHPD Bulletin No. 11 is an administrative streamlining measure. From 25 June 2026, applicants filing Class II and Class III product licence applications and amendments are no longer expected to include the finished product specification form in the submission package. Class I applications never included an FPS, so nothing changes there. The bulletin reduces submission paperwork and review friction. It does not reduce your quality obligations.

It helps to be precise about what the bulletin does and does not touch. The table below sets it out.

In other words, the only thing that moved is the filing step for two application classes. Everything that makes an FPS matter, the science behind it, the test methods, the acceptance limits and the person who signs it, is exactly where it was.

What a finished product specification actually is

A finished product specification is the written definition of what your product is and what it must meet before release. It sets the tests, analytical methods and acceptance criteria that confirm every batch is the correct identity, potency, purity and quantity. Health Canada describes the required content in the Quality of Natural Health Products Guide and in GUI-0158, the GMP guide for natural health products. It is the document that lets you say, with evidence, that the product on the shelf is the product you licensed.

A defensible FPS is not a one-page table of numbers. At minimum it links each attribute to a validated or verified test method and a justified acceptance limit. Common elements include:

• Identity of every medicinal ingredient, confirmed by a specific method rather than by a supplier certificate alone
• Quantity or potency of each medicinal ingredient, with a range that reflects overages and stability
• Purity and contaminant limits, including heavy metals, microbial limits and, where relevant, solvent residues, aligned to recognized pharmacopoeial standards
• Physical and organoleptic characteristics such as appearance, and disintegration or dissolution where applicable
• A test method for each attribute, with a reference to the validation or verification that supports it
• Acceptance criteria that are scientifically justified and consistent with the stability data and the shelf life you claim

Why 'no longer submit' does not mean 'no longer needed'

The requirement to hold and meet a finished product specification is set in law, not in a submission checklist. Section 44 of the Natural Health Products Regulations states that every NHP available for sale must comply with the specifications established for it, and section 44 of GUI-0158 interprets exactly what that means in practice. GUI-0158 version 4.0, in force since 4 March 2026, sits behind that duty. Removing the form from the application does not touch any of this. It moves the point of scrutiny to inspection, where the consequences are harder to manage.

The mechanism to understand is the Information Request Notice, or IRN. Health Canada can issue an IRN and ask for your FPS at any time, with no notice. At submission you have time to prepare. During an inspection or a targeted request you do not. A site with no defensible FPS now fails at inspection against the site licence, rather than being asked a clarifying question at product review. That is a worse place to be found short, because inspection findings carry compliance ratings, corrective action timelines and, in serious cases, restrictions on the ability to sell.

There is also a scope point that catches people out. The FPS is still required with a site licence application. So the document you no longer file with a product application is still expected elsewhere in the same regulatory relationship, alongside the wider GMP changes covered in our review of the 2026 NHP GMP reset. Reading Bulletin No. 11 as we do not need an FPS anymore gets both the timing and the scope wrong.

Which applications are affected

The change applies to Class II and Class III product licence applications and amendments. Class I applications are unaffected because an FPS was never part of that package. Higher-risk products can still be asked for an FPS during review. The table below summarizes where the change lands.

What an inspection-ready FPS file looks like

An inspection-ready FPS file is one a Health Canada inspector can pick up and follow from attribute to method to result without asking you to explain it. It ties every specification to a current test method, a validation or verification record, and a batch result that shows the limit is actually met. It is signed by a named quality person, dated, version-controlled, and consistent with your stability data and label claims.

In practice, the gaps we see most often during quality assurance gap assessments and mock inspections are not missing specifications. They are specifications that do not connect to anything. A number sits on a page with no method behind it. A method exists but was never validated for that matrix. Acceptance limits do not match the shelf life on the label. A certificate of analysis from a supplier is treated as identity testing, when GUI-0158 expects the site to confirm identity itself. Each of these is defensible to fix before an inspection and painful to explain during one.

Ownership matters as much as content. A finished product specification should be reviewed and approved by the quality unit, typically the Quality Assurance Person responsible for the site. If your FPS is a spreadsheet that no one owns, that is the first thing to fix, because an inspector will ask who is accountable for it.

Compliance checklist

Use this checklist to confirm your FPS programme is inspection-ready rather than submission-ready.

• Every marketed and pipeline product has a current, version-controlled finished product specification
• Each specification lists identity, potency or quantity, purity and contaminant limits, and physical attributes
• Each attribute is linked to a validated or verified test method
• Acceptance criteria are scientifically justified and consistent with stability data and shelf life
• Identity of each medicinal ingredient is confirmed by testing, not by supplier certificate alone
• The FPS is reviewed and signed by the Quality Assurance Person or delegated quality authority
• Specifications align with the Quality of Natural Health Products Guide and GUI-0158 version 4.0
• The FPS is retrievable quickly, so an Information Request Notice can be answered within the timeline given
• Site licence application records include the FPS where required
• A change control process governs any change to a specification

Common mistakes

• Reading the bulletin as deregulation. The submission step changed, the obligation did not. Companies that stop maintaining the FPS are exposed at their next inspection.
• Treating supplier certificates as identity testing. GUI-0158 expects the site to confirm the identity of medicinal ingredients, not to rely solely on incoming paperwork.
• Acceptance limits that do not match the label. If your shelf life claim is 24 months but your specification and stability data do not support it, the mismatch is a finding.
• Orphan specifications. A number with no method, or a method with no validation, will not survive scrutiny.
• No named owner. If no one in the quality unit signs and controls the FPS, accountability is unclear and the document loses weight at inspection.
• Slow retrieval. An FPS you cannot produce quickly during an IRN is, for practical purposes, a missing FPS.

Frequently asked questions

Do I still need a finished product specification for my NHP in 2026?

Yes. Health Canada removed the expectation to submit the FPS with Class II and Class III product licence applications from 25 June 2026, but the legal duty under section 44 of the Natural Health Products Regulations to establish and meet specifications is unchanged. You must still build, validate and maintain an FPS for every product.

What is an Information Request Notice and why does it matter now?

An Information Request Notice, or IRN, is a formal request from Health Canada for information, including your finished product specification. Because the FPS is no longer filed up front for Class II and III applications, the IRN is now the main way Health Canada verifies it. You can receive one at any time, so the FPS has to be ready before the request arrives, not after.

Does Bulletin No. 11 apply to Class I applications?

No. Class I product licence applications never included a finished product specification in the submission package, so nothing changes for them. The obligation to hold and meet specifications still applies to Class I products like any other NHP.

Is the FPS still required for a site licence application?

Yes. The change only affects product licence applications and amendments for Class II and Class III. A finished product specification is still expected as part of the site licence process, so the document has not disappeared from your regulatory obligations.

What happens if I cannot produce my FPS when Health Canada asks?

If you cannot produce a defensible FPS in response to an Information Request Notice or during an inspection, you risk a compliance finding against your site licence. Depending on severity, that can lead to corrective action requirements, an unfavourable inspection rating, or restrictions on your ability to sell the product. It is a far more serious position than answering a question at product review.

Who should approve the finished product specification?

The FPS should be reviewed and approved by the site quality unit, usually the Quality Assurance Person accountable for the site. Clear ownership, version control and dated signatures are what turn a specification from a working document into an inspection-ready record.

How MFLRC can help

MFLRC helps natural health product companies close the gap between a submission-ready file and an inspection-ready one. Our team drafts and remediates finished product specifications, runs GUI-0158 version 4.0 gap assessments, builds and validates the test methods and stability programmes that sit behind each specification, and prepares your quality unit to answer an Information Request Notice quickly and confidently. We provide Quality Assurance Person services, site and product licensing support, and inspection-readiness reviews. If you are also tracking the wider changes to NHP oversight, see our guides to Health Canada's plan to simplify NHP licensing and to 21 CFR Part 111 for Canadian NHP exporters. If Bulletin No. 11 has you wondering whether your FPS would hold up when Health Canada actually asks, that is exactly the question we help you answer before an inspector does.

Conclusion

NNHPD Bulletin No. 11 is a small administrative change with an outsized potential to mislead. Filing an FPS with your Class II and Class III applications is no longer expected, and that is genuinely helpful. The risk is in the inference. Removing a document from a submission does not remove it from your obligations. Section 44 of the Natural Health Products Regulations and GUI-0158 version 4.0 still require you to establish, meet and maintain finished product specifications, and Health Canada can ask to see them at any time. The companies that come out ahead will treat the FPS as a live quality document that runs production, not as a form they once submitted. Build it to survive an inspection, not just a review.

Sources and references

• Health Canada, Good manufacturing practices guide for natural health products (GUI-0158)
• Health Canada, GUI-0158 NHP GMP guidance, sections 43 to 47 (specifications)
• Natural Health Products Regulations (SOR/2003-196), Justice Laws Canada
• Health Canada, Natural Health Product Licensing Bulletin index