Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Special Access Program (drugs) (SAP)

Canada · Health Canada · New drugs

Early or compassionate accessHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

3 requirements

Application fee

What is the Special Access Program (drugs) in Canada?

Doctors and other practitioners can ask for a drug that is not sold in Canada to treat a patient in a medical emergency. The agency authorizes the maker to sell a set quantity to that practitioner. Serious or life-threatening conditions when usual treatments have failed, are unsuitable or are not available in Canada.

What are the steps of the Special Access Program (drugs)?

1. Practitioner sends the request form; 2. Decision; 3. Manufacturer ships the drug.

Does the Special Access Program (drugs) rely on other regulators?

Yes. It relies on approvals from European Union, United States (uses the reference review, uses the reference review).

Outcome: Letter of authorization to sell a specific quantity to the practitioner.

Legal basis: Food and Drug Regulations, section C.08.010

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

Official step durations

Steps

In order, with the official target for each step

1. Practitioner sends the request form
2. DecisionUrgent requests are usually resolved within hours. Others vary case by case.
3. Manufacturer ships the drug

Requirements

What the applicant must provide or meet

Eligibility

Medical emergencyA serious or life-threatening condition where usual treatments failed, are unsuitable or unavailable in Canada.
Request by a practitionerA health or dental practitioner asks for a drug not sold in Canada.

After approval

Report on use and adverse reactionsThe practitioner reports the results of use, including adverse reactions.

Official time targets

Targets, not actual review times

No time targets published.

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

Reliance on other regulators

European UnionUses the reference reviewThe agency may speed up its review when the EMA has authorized the drug for the same emergency.
United StatesUses the reference reviewThe agency may speed up its review when the US FDA has authorized the drug for the same emergency.

Other routes in Canada: New drug submission (new active substance), New drug submission or supplement (known substance), Abbreviated new drug submission (generic), Biosimilar new drug submission, DIN application with supporting data, Priority review, Notice of compliance with conditions, Extraordinary use new drug submission, Public health emergency drug (rolling review), Ministerial reliance order (foreign decision deeming), Access Consortium work sharing, Project Orbis (cancer drugs), Drug and device combination products. See all routes on the or explore them in the .

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.