Canada's New Drug Shortage Regulations: What Market Authorization Holders Must Do Now

Health Canada has finalized the most significant change to its drug and medical device shortage rules in almost a decade. The amendments were registered as SOR/2026-96 on 29 May 2026 and published in the Canada Gazette, Part II, Volume 160, Number 12, on 17 June 2026. Most of the drug provisions are already in force. This guide explains exactly what changed, what is only proposed and not yet law, and the steps market authorization holders (MAHs) should take now to stay compliant and inspection ready.

Executive summary

On 17 June 2026, Health Canada's amended shortage framework under the Food and Drug Regulations took effect. The headline change for drug MAHs is a new 12-month advance notice for discontinuations, up from the previous 6 months. Health Canada also gained authority to extend the shortage rules to drugs that were previously out of scope, including certain over-the-counter (OTC) products, through a new Expanded Scope List. New tools for exceptional importation and extended expiration dates were also formalized. Updated medical device shortage and discontinuation reporting follows one year later, on 17 June 2027.

Two points are widely misunderstood. First, the mandatory Shortage Prevention and Mitigation Plans (SPMPs), mandatory safety stock, and mandatory demand surge reporting that appeared in Health Canada's December 2024 proposal were not enacted in SOR/2026-96. They remain draft guidance and a signalled future direction. Second, the Critical and Vulnerable Drug List (CVDL) is now final, but Health Canada states it is not linked to any regulatory requirement yet. The practical path is to comply now with the reporting changes that are law, and to prepare in a structured way for the obligations likely to follow.

What actually became law on 17 June 2026

Direct answer: SOR/2026-96 amended the Food and Drug Regulations to strengthen drug shortage and discontinuation reporting, to let Health Canada expand the scope of drugs covered, and to add supply tools such as exceptional importation and extended expiration dates. These drug provisions came into force on publication, 17 June 2026. The updated medical device reporting provisions come into force on 17 June 2027.

The regulation comes into force in two phases, not the three-phase rollout described in the original proposal. The following came into force immediately on 17 June 2026:

• The Minister's authority to expand the scope of drugs subject to the shortage rules.
• The Minister's authority to extend expiration dates for specified drug lots to help manage a shortage.
• Updated frameworks for the exceptional importation and sale of drugs and medical devices.
• The updated reporting framework for drug shortages and discontinuations, including the new 12-month discontinuation notice.

The updated reporting framework for medical device shortages and discontinuations comes into force one year later, on 17 June 2027.

The 12-month discontinuation rule: the change most MAHs will feel first

Direct answer: MAHs must now report a decision to permanently stop selling a drug in Canada at least 12 months in advance. If the decision is made 12 months or less before the planned discontinuation, it must be reported within 5 days of that decision. This doubles the former 6-month notice period and gives the supply chain more time to respond.

Under the amended reporting provisions, the discontinuation report is filed on the third-party website Drug Shortages Canada, the same platform MAHs have used since March 2017. Two operational details deserve attention. First, the window to update an existing discontinuation report when information changes is now 5 days, aligned to the discontinuation timelines. Second, the change applies to discontinuations. The advance notice for an anticipated shortage remains 6 months, with reporting within 5 days once you determine a shortage will begin in 6 months or less, and updates to shortage reports within 2 days. Do not assume the 12-month period applies to shortages. It does not.

For MAHs, the practical impact is on internal decision timing. A commercial decision to delist a product now triggers a regulatory clock that is twice as long. Portfolio reviews, product transfers, and end-of-life planning need to feed the regulatory affairs function far earlier than before.

Expanded scope: how OTC drugs can be pulled into the framework

Direct answer: The shortage rules historically applied only to prescription drugs and drugs used under the supervision of a health professional. SOR/2026-96 gives Health Canada authority to apply the reporting and anti-diversion provisions to other drugs, including certain OTC products, by adding them to a new Expanded Scope List. As published, that list is currently empty, so no OTC product is captured yet, but the mechanism is live.

This is a structural shift. Before these amendments, non-prescription drugs, natural health products, and veterinary drugs sat outside the mandatory reporting regime. Health Canada's regulatory impact analysis estimates that up to 12 medicinal ingredients, representing roughly 75 uniquely identified drug products, could be brought into scope where an OTC shortage could present a risk of injury to human health. The lesson for OTC and consumer health MAHs is not to relax because the list is empty today. Health Canada can add products after consultation, and companies with critical OTC lines should build the reporting capability before they are named.

Natural health products remain outside this framework. They are regulated under the Natural Health Products Regulations, not the Food and Drug Regulations shortage provisions, so NHP-only companies are not directly captured. Companies that hold both drug and NHP portfolios should be careful not to apply drug shortage obligations to their NHP lines by mistake, or to overlook a drug-classified product they assumed was an NHP.

New supply tools: exceptional importation and extended expiration dates

Direct answer: The amendments formalize two shortage-management tools. Health Canada can authorize the exceptional importation and sale of foreign-authorized drugs to address a shortage, and it can extend the expiration dates of specified drug lots. Both give the supply chain more flexibility during a serious shortage.

The exceptional importation framework builds on the approach used during the COVID-19 period and is now a permanent, non-pandemic tool. Two obligations attach to it. Importers of exceptionally imported OTC drugs must include information that supports safe use, typically a printed information sheet. Importers of exceptionally imported drugs must also inform Health Canada of any serious adverse drug reaction reported in another jurisdiction for that product. These are new administrative duties that quality and pharmacovigilance teams should map into their procedures.

Medical devices: reporting changes arrive 17 June 2027

Direct answer: For medical devices, SOR/2026-96 removes the exemption that let manufacturers and importers skip reporting a shortage when a substitute device was available, and it introduces a 12-month advance notice for device discontinuations. These medical device reporting changes come into force on 17 June 2027, giving industry a full year to prepare.

Health Canada expects device shortage reports to rise significantly once the substitute-device exemption is removed. Device manufacturers and importers on the relevant shortage list should update their monitoring and reporting procedures now, well ahead of the 2027 date, and confirm who is accountable for filing. Companies that also hold a Medical Device Establishment Licence should align these duties with their existing quality system. For a refresher on device licensing obligations, see MFLRC's medical device regulatory support.

What is proposed but not yet law: SPMPs, safety stock, and demand surge reporting

Direct answer: Health Canada's December 2024 proposal included mandatory Shortage Prevention and Mitigation Plans, mandatory safety stock, and mandatory demand surge reporting. These were not enacted in SOR/2026-96. They remain draft guidance published for consultation and represent Health Canada's stated direction, not current legal requirements.

This distinction is where many summaries get it wrong, because early legal commentary described the full proposal before the final rule narrowed it. Here is what the draft guidance describes, so MAHs can prepare with clear eyes:

• Shortage Prevention and Mitigation Plans (SPMPs). As proposed, MAHs of drugs on the CVDL would prepare a written plan describing how they identify and assess shortage risks, the risks identified, measures to prevent or mitigate those risks, measures to reduce the impact of a shortage, how they evaluate effectiveness, and how they alert Health Canada to a significant increase in shortage likelihood. The draft would require the plan on request within 24 hours and review at least every three years.
• Safety stock. As proposed, MAHs of certain drugs would hold a safety stock in Canada. For the first tier of the draft list this was three months of average monthly demand from the prior calendar year, with monthly record keeping retained for three years.
• Demand surge reporting. As proposed, drug establishment licence holders such as importers and wholesalers would report a significant demand surge, defined as a monthly sales increase of at least 250 percent versus the same month in the prior year, within 5 days after month end.

None of these are enforceable today. Health Canada has signalled that regulatory action, rather than voluntary measures, is its preferred path, and its published plan, Building Resilience: Health Canada's plan to address health product shortages, 2024 to 2028, points in the same direction. Preparing now is prudent risk management, not premature compliance.

The Critical and Vulnerable Drug List (CVDL): what it is and how to use it

Direct answer: The CVDL is Health Canada's finalized list of drugs that are most likely to cause serious harm if they go into shortage, or that have features making them more vulnerable to shortage. Health Canada states plainly that a listing does not mean a shortage exists and that the CVDL is not linked to any regulatory requirement yet. It is a planning and prioritization tool.

The list was built using a criticality and vulnerability scoring method and covers categories such as anti-infectives and antibiotics, oncology and anti-neoplastic agents, vaccines, intravenous fluids and electrolytes, critical care medicines, hormones, and coagulation factors. Even though the CVDL carries no direct legal obligation today, it is the clearest available signal of where future SPMP and safety stock obligations will land. If any of your products appear on it, treat that as your early warning to begin structured shortage-risk planning.

Comparison at a glance

Compliance checklist for MAHs

1. Update your discontinuation SOP to the 12-month notice, with the 5-day fallback and the 5-day update rule.
2. Reconfirm that anticipated shortage reporting stays at 6 months and 5 days, and that shortage report updates stay at 2 days.
3. Verify your Drug Shortages Canada account access, user roles, and backup reporter coverage.
4. Add a regulatory checkpoint to any product delisting or end-of-life decision, triggered at the commercial decision stage.
5. Screen your portfolio against the CVDL and flag any listed products for shortage-risk planning.
6. For OTC and consumer health lines, build reporting capability before any Expanded Scope List addition names your product.
7. Map the new exceptional importation duties, safe-use information and foreign serious adverse drug reaction reporting, into your quality and pharmacovigilance SOPs.
8. For medical devices, prepare for the 17 June 2027 reporting changes, including removal of the substitute-device exemption.
9. Draft a shortage prevention and mitigation plan template now for your highest-risk products, so you are ready if the requirement is finalized.
10. Assign clear ownership. Confirm who holds accountability for shortage reporting, and document escalation paths.

Common mistakes to avoid

• Treating SPMPs and safety stock as current legal requirements. They are proposed guidance, not law under SOR/2026-96.
• Applying the 12-month notice to anticipated shortages. It applies to discontinuations only.
• Assuming OTC products are safe because the Expanded Scope List is empty. Health Canada can add products after consultation.
• Confusing the CVDL with a regulatory obligation. It is a planning list with no direct duty attached today.
• Applying drug shortage rules to natural health products. NHPs sit under a separate framework.
• Waiting until 2027 to plan for medical device reporting changes. The volume of reports is expected to rise sharply.
• Leaving discontinuation timing to the commercial team alone, so regulatory affairs learns too late to meet the 12-month clock.

Frequently asked questions

When must a drug discontinuation be reported in Canada?

Under SOR/2026-96, an MAH must report a decision to discontinue a drug at least 12 months before sales stop. If the decision is made 12 months or less before discontinuation, it must be reported within 5 days of the decision. This replaces the former 6-month notice.

Did the anticipated shortage reporting timeline change?

No. Anticipated shortages are still reported when you determine a shortage will begin in 6 months or less, within 5 days of that determination, with updates to shortage reports within 2 days. Only the discontinuation notice moved to 12 months.

Are over-the-counter (OTC) drugs now covered by the shortage rules?

Not automatically. SOR/2026-96 lets Health Canada add drugs that were previously out of scope, including certain OTC products, to a new Expanded Scope List. That list is currently empty, but the mechanism is in force, so OTC MAHs should prepare to report if named.

Is a Shortage Prevention and Mitigation Plan (SPMP) mandatory now?

No. Mandatory SPMPs, safety stock, and demand surge reporting were in Health Canada's December 2024 proposal but were not enacted in SOR/2026-96. They remain draft guidance and a signalled future direction. Preparing early is still recommended.

What is the Critical and Vulnerable Drug List (CVDL)?

It is Health Canada's finalized list of drugs most likely to cause serious harm if in shortage, or that are more vulnerable to shortage. Health Canada states it is not linked to any regulatory requirement yet, so treat it as a planning and prioritization tool.

When do the medical device reporting changes take effect?

The updated medical device shortage and discontinuation reporting provisions, including removal of the substitute-device exemption and a 12-month discontinuation notice, come into force on 17 June 2027, one year after the drug provisions.

How MFLRC can help

Navigating a shifting shortage framework is exactly the kind of work MFLRC does every day. Our team helps drug, generic, OTC, and medical device MAHs turn regulatory change into practical, defensible systems. We can:

• Run a shortage-compliance gap assessment against SOR/2026-96 and the draft SPMP and safety stock guidance, so you know precisely where you stand.
• Draft or update your shortage and discontinuation reporting SOP suite, aligned to the 12-month rule and Drug Shortages Canada workflows, through our regulatory affairs and licensing services.
• Build a shortage prevention and mitigation plan template and a CVDL screening process as part of a resilient quality management system.
• Prepare you for inspection with mock audits and CAPA review through our audit services.
• Support pharmaceutical, OTC and prescription and medical device portfolios, and advise controlled drug and natural health product sponsors on where these rules do and do not apply.

Need help getting shortage ready? Book a consultation with MFLRC and turn this regulatory change into a competitive advantage. You can also explore more of our regulatory articles for practical Health Canada guidance.

Conclusion

Canada's shortage framework has moved from a light-touch reporting regime toward a more active supply-resilience model. The parts that are law today, the 12-month discontinuation notice, the expanded scope mechanism, and the new supply tools, are manageable with updated SOPs and clear ownership. The parts that are coming, mandatory SPMPs and safety stock tied to the Critical and Vulnerable Drug List, reward companies that prepare early. The MAHs who treat this as a systems upgrade, rather than a paperwork exercise, will spend less time firefighting and more time supplying the Canadian market with confidence.

Sources and references

• Canada Gazette, Part II: SOR/2026-96, Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of Drugs and Medical Devices).
• Health Canada: Drug shortages in Canada, Regulations and guidance.
• Health Canada: Critical and Vulnerable Drug List.
• Health Canada: Draft for consultation, Guide to shortage prevention and mitigation plans.
• Drug Shortages Canada reporting website.