New Rules for Drug and Device Shortages

Summary#

These final regulations change the Food and Drug Regulations and the Medical Devices Regulations to strengthen how shortages and the stopping of sales are tracked and handled. The rules give Health Canada new powers to expand which drugs/devices must be reported, to allow some foreign or extended‑expiry supplies during shortages, and to require earlier notices from manufacturers; most changes take effect on publication (June 17, 2026) while some medical‑device reporting rules come into force on June 17, 2027.

What it does#

• Gives the Minister of Health the power to add specific drugs or drug classes to a government list so those products become subject to shortage and discontinuation rules.

  • This list will be kept on a Government of Canada website and can be changed over time.

• Changes timing and public posting rules for shortages and discontinuations (plain summary of the main timing changes):

  • If a manufacturer decides to stop selling a drug, they must notify the public and Health Canada earlier — generally at least 12 months before stopping. If the decision is made less than 12 months before stopping, it must be posted within 5 days.
  • If a drug is in shortage, manufacturers must post shortage info and update changes quickly (shortage updates within 2 days; when supply is restored, post within 2 days).
  • For medical devices, manufacturers or (for Class I) importers must post shortage notices; if a shortage is anticipated more than 6 months ahead, post at least 6 months before; if within 6 months, post within 5 days; unexpected shortages must be posted within 5 days. Device updates generally must be updated within 2 days.

• Allows Health Canada to require information about potential shortages for any drug that could cause injury to health if it were in short supply — not just drugs already covered by the old rules.

• Creates a way to formally extend the expiry date for specific lots/batches of authorized Canadian drugs in shortage. If a lot is added to the new online list of extended expiry dates, sellers must notify customers within 5 days. That gives a short-term increase in usable supply.

• Broadens and clarifies the “exceptional importation and sale” pathways so foreign‑authorized drugs and some domestically made lots can be used as substitutes during shortages. Notable points:

  • The framework can now be used for some over‑the‑counter drugs and for replacements of drugs discontinued in Canada for up to 36 months after discontinuation.
  • Sellers/importers of such products must make safe‑use information available in English and French at the point of sale.
  • Importers/sellers of these exceptional products must report certain serious adverse reactions within 15 days, and must report certain foreign regulatory actions within 72 hours.

• Changes how shortage and discontinuation information is shared publicly: drug and medical‑device shortage reports will be posted on a designated (third‑party) website that Health Canada links to, rather than some reports going directly to the department.

• Requires importers/establishment licence holders to keep more detailed records and to provide information to Health Canada on request (for example, measures to prevent or mitigate shortages).

Who's affected#

• Manufacturers and market authorization holders of drugs (prescription, certain over‑the‑counter products, biologics, radiopharmaceuticals, controlled drugs).
• Holders of drug and medical‑device establishment licences (importers, fabricators, packagers, wholesalers).
• Medical‑device manufacturers and importers, including Class I device importers.
• Pharmacies, hospitals, practitioners and wholesalers who may sell or handle exceptionally imported products.
• Patients and clinicians who use drugs or devices that could be in shortage.
• Health Canada and the third‑party operator of the designated website.
• Small businesses in the sector — the regulatory analysis estimates around 190 small businesses could be affected each year.

If the source is unclear about exactly which specific products will be added to the new lists, that will depend on future decisions by the Minister and the lists published on the government website.

Why it matters#

• Faster, clearer warning: the rules require earlier and more standardized public posting of shortages and discontinuations. That gives hospitals, pharmacists and patients more time to find alternatives or plan transitions.
• More supply options in shortages: the government can extend expiry dates for specific lots and bring in foreign‑authorized or domestic substitute products more easily. That can reduce shortages or the need for patients to stop treatments.
• Better safety checks: importers and sellers of exceptional products must share adverse‑reaction reports and certain foreign regulatory actions, so Health Canada has better real‑time safety information.
• Some extra paperwork and modest costs: Health Canada’s impact analysis estimates total quantifiable annual costs of roughly $728,000 per year (present value $5.1 million over 10 years) and monetized benefits of about $245,000 per year (present value $1.7 million). The net monetized impact is a cost of about $483,000 per year (present value $3.4 million over 10 years). These are national, program‑level estimates from the regulatory impact statement.