Health Canada’s special access programs: Request a veterinary drug through EDR

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Who can apply

Through the emergency drug release (EDR) program, veterinary practitioners (veterinarians) may request authorization to access unapproved drugs for emergency veterinary use.

A veterinarian is registered and entitled under the laws of a province or territory to practise veterinary medicine. This person is practising their profession in that province or territory.

Emergency use is for an animal or group of animals with serious or life-threatening conditions that can't be treated with conventional therapies. These therapies have failed, are not suitable or are not available in Canada.

With authorization through the EDR program, a manufacturer may sell an unapproved drug to a veterinarian. In some cases, a manufacturer may request authorization to import a drug into Canada in advance (referred to as pre-positioning) of an authorization to sell to a requesting veterinarian.

How to apply

Before submitting your EDR request, first confirm that the manufacturer (drug supplier) can supply the drug to you.

Once you have confirmed, follow these 2 steps:

  1. Complete and sign these forms:
  2. Send your completed forms to the Veterinary Drugs Directorate by fax at 613-946-1125 or by email at edr-dmu@hc-sc.gc.ca

We will contact you within 2 business days. If your request is urgent or if you have not received a follow-up response in this time, contact the EDR program.

After you apply

You must also report annually to Health Canada if the requested drug you are using is:

If this is the case, provide information on:

To report, you need to ask to be added to the veterinary antimicrobial sales reporting system by emailing us at: vasr-vavr@hc-sc.gc.ca.

Note: If the requested drug on List A was present in Canada at the time of its sale, the manufacturer will do the reporting.

Your responsibilities

It is your responsibility to:

Cost

There is a fee for each EDR request. After we issue your EDR authorization, we will send you an invoice with payment instructions.

On April 1, 2020, we implemented new measures to reduce fees to help small businesses. Veterinarians who qualify under Health Canada's small business definition may receive a fee reduction.

To receive a fee reduction, you must apply for small business status before submitting your EDR request. Otherwise, you will be invoiced the full fee. Small business status is valid for 1 year from issuance and can be used on multiple EDR requests.

For more information and to apply for small business fee reduction, visit small business fee reduction measures.

Publicly funded health care institutions and federal, provincial or territorial governments are exempt from fee payment.

The manufacturer determines the cost of the drug and shipping.

How we process requests

You can contact the EDR program during business hours from Monday to Friday.

You may be asked to provide additional information to help us make a decision about your EDR request. The level and type of information depends on whether we have already authorized the drug for the same veterinary use. We consider information about the nature of the medical emergency, including its credibility and relevance to the medical emergency.

Other considerations include if the request is:

If a drug has not been previously authorized by the EDR program for the same use, you will be asked to provide additional information on:

You will not be asked to provide safety and efficacy information:

To find out if a drug has been previously authorized by the EDR program for the same use, contact us.

You will receive a letter of authorization if the information you provide meets the EDR program criteria. The letter of authorization is valid until the quantity of drug identified is depleted or expires.

Requests may not be authorized if there are concerns about:

If this is the case, we will contact you to discuss.

You may cancel your EDR request at any time before the drug is shipped from the manufacturer by contacting the EDR program. This applies even if we have issued a letter of authorization.

Information for manufacturers

Manufacturers can request authorization to import an unapproved drug in Canada for anticipated EDR authorizations through the EDR program.

How to apply

Follow these 2 steps:

  1. Complete and sign the Emergency Drug Release Pre-Positioning Form (no fee)
  2. Send your completed form to the Veterinary Drugs Directorate by fax at 613-946-1125 or by email at edr-dmu@hc-sc.gc.ca

We will contact you within 2 business days.

After you apply

If this is the case, provide information on:

To report, you need to request to be added to the veterinary antimicrobial sales reporting system by emailing us at: vasr-vavr@hc-sc.gc.ca.

Note: If the requested drug that is on List A was not present in Canada at the time of its sale, the veterinarian (as the person importing the drug) will do the reporting (not the manufacturer).

Your responsibilities

When providing the requested drug to the veterinarian:

When submitting the pre-positioning request for a drug:

You must also:

Contact us

For questions about the EDR program, contact us during business hours from Monday to Friday.

Emergency Drug Release
Veterinary Drug Directorate

Telephone: 613-240-3916
Fax: 613-946-1125
Email: edr-dmu@hc-sc.gc.ca

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