Health Canada's special access programs: Overview

Through Health Canada's special access programs (SAP), health care professionals may access non-marketed drugs and medical devices not yet approved for sale in Canada.

These programs are not to be used to:

  • promote or encourage the early use of drugs or medical devices
  • conduct research
  • bypass the clinical trial, drug or medical device review process

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Special access program for drugs

Through SAP, health care professionals may request access to non-marketed drugs to treat patients with serious or life-threatening conditions. Access to these drugs is only considered when conventional therapies have failed, are unsuitable or are unavailable.

A SAP authorization allows a manufacturer to sell a drug that has not been approved for sale in Canada. Drugs considered for release under SAP include pharmaceutical, biologic and radiopharmaceutical products.

Regulations and policy

Sections C.08.010 and C.08.011 of the Food and Drugs Regulations support access through SAP to these drug products. The exception are drugs that are or contain a "restricted drug" as defined in part J of the Regulations.

Special access program for medical devices

Through SAP, health care professionals may access medical devices that have not yet been approved for sale in Canada. Special access is given for emergencies or when conventional therapies have failed, are unavailable or are unsuitable to treat a patient.

Special access authorization is required for all medical devices that have not been approved for use in Canada, as well as some custom-made devices.

Regulations and policy

Part 2 (special access provisions) of the Medical Devices Regulations, under the Food and Drugs Act, supports the ability of health care professionals to access custom-made and unlicensed medical devices.

Emergency drug release program for veterinary drugs

Through the Emergency Drug Release (EDR) program, veterinary practitioners may request access to unapproved drugs to treat patients (an animal or group of animals) with serious or life-threatening conditions. Access to these drugs is only considered when conventional therapies have failed, are unsuitable or are unavailable. The EDR program may also authorize a manufacturer to sell a drug for veterinary use that has not been approved for sale in Canada.

Regulations and policy

Sections C.08.010 and C.08.011 of the Food and Drug Regulations support the authorization of EDR requests by veterinary practitioners. The exception are drugs that are or contain a "restricted drug" as defined in part J of the Regulations.

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