Health Canada's special access programs: Request a drug

If you're a health care professional, you can request a drug that is not available for sale in Canada through the Special Access Program (SAP). Your request must be for treating a patient with a serious or life-threatening condition where conventional treatments:

• have failed
• are unsuitable or
• are not available in Canada

For access to SAP, a health care professional is someone who:

• is entitled, under the laws of a province or territory, to treat patients with an unapproved prescription drug
• practises in that province or territory
• has prescribing privileges in the respective province

Most often, a licensed physician is the health care professional who uses SAP. If in doubt, you should consult your professional college for information on your scope of practice.

When requesting a drug through SAP on behalf of your patients, you must:

• ensure your patients are well informed of the possible risks and benefits of the drug being requested and its development status
• provide a report to Health Canada on the results of the use of the drug, including any adverse reactions
• maintain accurate and accessible records in the event that you are asked to account for quantities of the drug received
• ensure that the decision to prescribe the drug is supported by credible evidence available in relevant medical literature or provided by the manufacturer

In some cases, a foreign manufacturer may consider importing a drug into Canada for pre-positioning before receiving authorization to sell to a requesting practitioner.

How to apply

For a patient-specific request

To submit a request to access non-marketed drugs used to treat, diagnose or prevent serious or life-threatening conditions in a patient:

1. Complete and sign the SAP request form (PDF Version, 379 KB).
   • (Microsoft Word version, 117 KB)

In a critical emergency, please contact SAP by telephone at 613-941-2108.

1. Fax your completed form, without a cover sheet, to 613-941-3194.
2. Wait for a decision.

For a future use request

To access a non-marketed drug for a future medical emergency, you must give a valid reason for needing the drug in advance rather than for a specific patient. To submit a future use request:

1. Complete and sign the future-use form (PDF version, 560 KB).
   • (Microsoft Word version, 120 KB)
2. Fax your completed form, without a cover sheet, to 613-941-3194.
3. Wait for a decision.

Note: We will consider expediting our review for a drug:

• previously authorized through SAP for the same medical emergency
• authorized by the European Medicines Agency or the US Food and Drug Administration for the same medical emergency

Cost

The manufacturer determines the cost of the drug. In some cases, drugs released through SAP are free.

If there's a charge, hospitals, public or private insurers or, in some cases, patients or their families will cover the cost.

How we process requests

The Special Access Program receives about 1000 requests each month. All requests are administratively processed and subject to triage to determine priority of incoming requests. Time-sensitive requests e.g. for immediate life-threatening conditions receive the highest priority and are typically processed and resolved within hours of receipt.

Other factors that can affect triage and time to assess requests include: proposed treatment dates that are weeks in advance, deficiencies in requests that require follow-up discussions with practitioners, and the need to clarify aspects of a patient’s medical history. Requests for drugs new to SAP or for those with limited evidence of safety and efficacy for a given condition may require additional time for a decision to be made, to allow for communication with manufacturers and practitioners.

After our review, we will make a decision as follows:

• Authorization: The information meets SAP criteria.
  • We will fax a letter of authorization to the manufacturer and send a copy to the health care professional.
  • We will contact you if there is missing information or to clarify your request.
  • If we are considering denying the request, we may contact the health care professional to discuss the reasons for this. After the phone call, it is possible we may reconsider our decision.
  • We will send a letter, by fax, explaining our decision to the health care professional.

  Mandatory reporting requirements

  Follow-up form

  To report outcomes, including adverse reactions, from using the drug:

  1. Complete, sign and date the follow-up form (PDF version, 351 KB).
     • (Microsoft Word version, 113 KB)
  2. Fax your completed form, without a cover sheet, to 613-941-3194.

  Information for manufacturers

  Drugs accessed through SAP are supplied directly by manufacturers to health care professionals.

  Authorized drugs can only be sent to:

  • the office of the health care professional who made the request
  • pharmacies
  • community pharmacies
  • radiopharmacies
  • blood banks

  The manufacturer may impose restrictions or conditions on the release of the drug to ensure it is used correctly.

  Manufacturers are also responsible for providing all drug information to health care professionals who request it.

  Pre-positioning

  In some cases, a foreign manufacturer may want to import a drug into Canada for pre-positioning before a health care practitioner makes a request through SAP. To pre-position a drug, a manufacturer must:

  • provide information about the medical emergency and how the new drug being imported will be used
  • give a rationale as to why the product needs to be pre-positioned
  • explain the urgency of having the product in Canada, including if the drug requires timely administration
  • specify the quantity of drug to be pre-positioned
  • identify the Canadian importer who will pre-position the drug in a Canadian facility (must hold an establishment licence in Canada)

  To apply, follow these steps:

  1. Complete and sign the pre-positioning form (PDF version, 240 KB).
     • (Microsoft Word version, 111 KB)
  2. Fax your completed form, without a cover sheet, to 613-941-3194.
  3. Wait for a decision from SAP.

  Contact us

  Access to SAP is available 24 hours a day, 365 days a year.

  Regular business hours are from 8:30 am to 4:30 pm Eastern Standard Time, Monday to Friday.

  On-call service is available for emergencies outside regular hours (evenings, nights, weekends and holidays) from 4:30 pm on Friday to 8:30 am on Monday. On a statutory holiday, on-call service continues until 8:30 am on the first business day following the holiday.

  For questions about SAP, contact us:

  Special Access Program
  Pharmaceutical Drugs Directorate

  Telephone: 613-941-2108
  Fax: 613-941-3194
  E-mail: sapd-pasm@hc-sc.gc.ca

  Related links

  • Notice: Clarifications Regarding Access to Restricted Drugs through the Special Access Program (SAP)
  • Special Access Program for drugs: Guidance document for industry and practitioners
  • Canada Gazette, Part II