SOR/2025-244: Every Cannabis Regulations Change In Force 1 October 2026

On 1 October 2026, a large and largely unnoticed amendment to Canada's Cannabis Regulations comes into force. It is called SOR/2025-244, the Regulations Amending the Cannabis Regulations (Harmonization with Certain Provisions of the Controlled Substances Regulations). It was registered on 28 November 2025 and published in the Canada Gazette, Part II, on 17 December 2025, yet many licence holders, licensed dealers and pharmacy teams have never heard of it. That is a problem, because it changes how you keep records, who can be designated to run your facility, how drug identification numbers are recorded, how test kits are registered, and even what a patient may carry across the border.

The instrument does not arrive alone. It shares its in-force date with SOR/2025-242, the new Controlled Substances Regulations, so 1 October is the single most important compliance date of the autumn for any organization that touches cannabis or controlled drugs. There is no phase-in and no transitional provision. The rule simply applies on the day. This guide explains, in plain language, what SOR/2025-244 actually changes and the practical steps a Canadian organization should take now.

Executive summary

The table below sets out the cluster of instruments and guidance that all take effect on 1 October 2026. Reading them together, rather than one at a time, is the only way to plan the work.

Instrument or guidance	Sector	What it does
SOR/2025-244 Cannabis Regulations harmonization	Cannabis	Aligns cannabis recordkeeping, designations and drug provisions with the controlled-substances framework
SOR/2025-242 Controlled Substances Regulations	Controlled drugs	Consolidates the existing controlled-substances regime into one modernized regulation
Health Canada foreign-action notification list	Pharma and NHP	Revises the list of foreign authorities and jurisdictions whose actions trigger reporting
HC guidance: summary reports for marketed drugs and NHPs	Pharma and NHP	New expectations for preparing and submitting annual summary reports

What SOR/2025-244 actually is

What it is: SOR/2025-244 is a regulation made under subsection 139(1) of the Cannabis Act that amends the Cannabis Regulations (SOR/2018-144). Its stated purpose is harmonization, meaning it brings cannabis requirements into line with the parallel provisions of the new Controlled Substances Regulations so that organizations working across both frameworks see consistent rules. Why it matters: harmonization sounds administrative, but the detail is substantive. Dozens of provisions change, several new ones are created, and three are repealed. What to do: treat this as a full regulatory change, not a cleanup. Map every amended provision to the SOP, record or designation it touches, and assign an owner and a due date before 1 October 2026.

Because the amendment is a harmonization exercise, it is best understood alongside its companion instrument. Our analysis of what the new Controlled Substances Regulations (SOR/2025-242) mean for manufacturers and dealers explains the framework that SOR/2025-244 is aligning to. One drafting point is worth stating up front: the Regulatory Impact Analysis Statement that describes costs and rationale is published with SOR/2025-242 and covers the whole package, so any burden estimate should be read as package-wide rather than attributed to the cannabis amendment alone.

Two-year record retention, now uniform

What it is: SOR/2025-244 writes an "at least two years" retention period into five separate provisions of the Cannabis Regulations, at sections 146(7), 179, 187, 195 and the new 195.3. Why it matters: retention periods have historically been scattered and inconsistent across the cannabis framework, which made records matrices hard to build and easy to get wrong. A single, repeated standard removes the ambiguity, but it also removes any excuse. If your document control procedure still names a different period for these records, it is now out of step with the regulation.

What to do: rebuild your records retention matrix so that the records tied to these provisions are held for at least two years, confirm that your electronic systems will not auto-purge inside that window, and update the retention clause in your recordkeeping SOP. Two years is a floor, not a ceiling, so where other obligations (tax, provincial, or contractual) require longer, the longer period governs.

Travelling with prescription cannabis: the new 90-day rule

What it is: a new Division 3, at sections 195.4 and 195.5, creates a controlled pathway for an individual to import into, or export from, Canada a drug containing cannabis for their own medical use. The quantity is capped at a 90-day supply based on the daily dose shown on the label. Why it matters: this is genuinely new ground and the rules for coming in and going out are not the same. Importation requires the traveller to declare the drug to a customs officer and to carry it in its labelled container from a health care practitioner. Exportation, under section 195.5, does not carry the same customs-declaration requirement. That asymmetry matters to pharmacists and practitioners who counsel travelling patients.

What to do: if you operate a pharmacy or advise patients, add a short patient-counselling note that captures the 90-day limit, the labelled-container requirement and the declare-on-import step. The comparison below sets out the key differences.

Requirement	Importing into Canada (s. 195.4)	Exporting from Canada (s. 195.5)
Quantity limit	90-day supply at the labelled daily dose	90-day supply at the labelled daily dose
For personal medical use	Yes	Yes
Labelled container from a practitioner	Yes	Yes
Declaration to a customs officer	Required	Not required under the export provision

New recordkeeping duties for licensed dealers

What it is: new sections 195.1 to 195.3 introduce a licensed-dealer recordkeeping regime inside the Cannabis Regulations that did not previously exist there. Why it matters: licensed dealers handling drugs containing cannabis now have explicit, cannabis-side record obligations that mirror the controlled-substances approach. If your records program was built only around the controlled-drugs rules, it may not satisfy the cannabis provisions once they apply. What to do: dealers should review their transaction and inventory records against the new sections, confirm the two-year retention in section 195.3 is built in, and close any gaps between their controlled-substances records and the new cannabis-side requirements.

Master grower and designated-person duties rewritten

What it is: the duties of the master grower are rewritten at sections 12(2) and 15(2) in matching terms, making the master grower responsible for the cultivation, propagation and harvesting of cannabis and requiring sufficient knowledge of the applicable provisions of the Act and the Regulations. Related designated-person provisions are also refreshed. Why it matters: these are named, accountable roles. When the wording of a duty changes, the qualification file behind the person holding that role should be revisited so it still demonstrates the knowledge the regulation now describes. Inspectors routinely ask to see how a designated individual meets the stated requirements.

What to do: review each designation against the revised duty wording and rebuild the credential and equivalency file where needed. A structured quality assurance and designated-person review is a fast way to confirm your master grower, quality assurance person and other named roles still hold up under the new language.

Drug identification numbers, test kits and promotion exemptions

What it is: three further sets of changes round out the amendment. First, drug identification number records are inserted across the provisions dealing with drugs containing cannabis and combination products, and the definition of combination product is updated to mean a product consisting of a device and a prescription drug that has a drug identification number. Second, the test-kit regime is rebuilt, with a new section 260.1 setting out grounds on which Health Canada must refuse to register a test kit and section 261 governing mandatory cancellation and kits already manufactured. Third, new promotion and sponsorship exemptions are created from sections 21 and 22 of the Cannabis Act, at sections 163 and 164 for prescription drugs and sections 198 and 199 for combination products.

Why it matters: these changes reach QA records, product registration and marketing review all at once. A combination product team, a regulatory affairs lead and a marketing reviewer could each be affected without realizing the others are too. What to do: confirm that drug identification numbers are captured in the relevant records, reconcile your combination-product documentation with the updated definition, re-examine any test-kit registrations against the new refusal and cancellation grounds, and have your promotional review procedure updated so the new exemptions are applied correctly rather than ignored.

A terminology sweep also runs through the amendment, replacing references to a "professional licensing authority" with a "professional regulatory authority" across many provisions, and three provisions (sections 173, 196 and 263) are repealed. These are smaller items, but they still need to be reflected wherever your SOPs quote the old wording.

Compliance checklist before 1 October 2026

Use the following checklist to convert the amendment into assignable work. Each item should have an owner and a completion date ahead of the in-force date.

Rebuild the records retention matrix so the records tied to sections 146(7), 179, 187, 195 and 195.3 are held for at least two years, and confirm no system auto-purges inside that window.
Review licensed-dealer records against the new sections 195.1 to 195.3 and close any gaps against the controlled-substances records you already keep.
Re-verify every designated-person file, especially the master grower under sections 12(2) and 15(2), against the revised duty wording.
Confirm drug identification numbers are captured in all required records and reconcile combination-product documents with the updated definition.
Re-examine any test-kit registrations against the new refusal grounds in section 260.1 and cancellation rules in section 261.
Update promotional review procedures so the new exemptions at sections 163, 164, 198 and 199 are applied correctly.
Add a patient-counselling note for the 90-day travel rule, covering the labelled container and the declare-on-import requirement.
Search and replace "professional licensing authority" with "professional regulatory authority" in every SOP that quotes it, and remove references to the repealed sections 173, 196 and 263.

Common mistakes to avoid

Treating it as a cleanup. The word harmonization hides real substantive change. Reading the summary and moving on is how organizations miss the dealer records regime and the designation rewrites.
Waiting for a transition period that does not exist. Section 65 sets a single, unqualified in-force date. There is no grace period to fall back on.
Assuming import and export rules match. The customs-declaration step applies to importation, not to the export provision. Counselling patients as though the two are identical is an easy error.
Updating the retention clause but not the system. A two-year policy means little if an archiving tool still deletes records at eighteen months.
Attributing package costs to the wrong instrument. The cost and burden analysis lives with SOR/2025-242 and covers the package, so quoting a figure as if it belonged to SOR/2025-244 alone is not defensible.

Frequently asked questions

When does SOR/2025-244 come into force?

Section 65 of SOR/2025-244 states that the regulations come into force on 1 October 2026. It is a single, unqualified date with no transitional provisions, so every amended requirement applies from that day.

How long must cannabis licence holders keep records under the new rules?

At least two years. The amendment writes an "at least two years" retention period into sections 146(7), 179, 187, 195 and the new 195.3. Where another obligation requires a longer period, the longer period applies.

Can a patient bring prescription cannabis into Canada?

Yes, up to a 90-day supply at the labelled daily dose, under the new section 195.4, provided it is for personal medical use, carried in its labelled container from a health care practitioner, and declared to a customs officer on arrival.

Is a customs declaration required when leaving Canada with prescription cannabis?

The export provision, section 195.5, sets the same 90-day personal-use limit but does not carry the customs-declaration requirement that applies on import. The requirements for coming in and going out are not identical, which is why patient counselling should address each separately.

What are a master grower's responsibilities under the amended regulations?

Under the revised sections 12(2) and 15(2), the master grower is responsible for the cultivation, propagation and harvesting of cannabis and must have sufficient knowledge of the provisions of the Act and the Regulations that apply to those activities. The qualification file behind the role should demonstrate that knowledge.

Does SOR/2025-244 replace the Controlled Substances Regulations changes?

No. SOR/2025-244 amends the Cannabis Regulations to harmonize them with the separate new Controlled Substances Regulations (SOR/2025-242). The two instruments are companions that come into force on the same day, 1 October 2026, and are best planned together.

How MFLRC can help

MF License & Regulatory Consultants works with cannabis licence holders, licensed dealers and pharmacy teams across Canada. For SOR/2025-244 we run a section-by-section gap assessment that maps each amended provision to the SOP, record or designation it affects, then help you rewrite the affected procedures, rebuild your records retention matrix, and refresh designated-person files. Our regulatory affairs, licensing and import/export team and our audit services team can also run a mock inspection against the new requirements so you know where you stand before an inspector does.

With only a short window to the in-force date, a focused readiness map is the practical way to reach 1 October with confidence rather than exposure.

Book a SOR/2025-244 Gap Assessment

Conclusion

SOR/2025-244 is a large amendment wearing a modest name. It changes retention periods, creates a dealer records regime, rewrites designation duties, reaches into drug identification number records and test kits, adds promotion exemptions, and opens a controlled travel pathway, all on 1 October 2026 with no phase-in. The organizations that do well will be the ones that started early, mapped the changes to their own documents, and treated the date as the deadline it is. If cannabis and hemp sit in your regulated market, now is the time to build the readiness plan.