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:
- Complete and sign these forms:
- 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
- We may request more information to help us make a decision
- If a request is authorized, we will issue a letter of authorization to the requesting veterinarian and the manufacturer
- You must submit the Emergency Drug Release Follow-Up Form with the results of the use of the drug:
- including any adverse events
- accounting for all quantities of the requested drug
You must also report annually to Health Canada if the requested drug you are using is:
- a medically important antimicrobial for veterinary use on List A and
- not present in Canada at the time of its sale (this means you are the person importing the drug)
If this is the case, provide information on:
- the total quantity sold or distributed
- the approximate quantity sold or distributed for each intended animal species
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:
- inform your clients of the drug's possible benefits and risks, as well as regulatory status (not approved for sale in Canada)
- use the drug appropriately, taking into account:
- its safety and efficacy in the intended species
- drug withdrawal times relative to safety of the food(s) derived from treated animals
- the quantity of the drug in the letter of authorization and who may receive the shipment (such as another practitioner, pharmacist or commercial medicated feed mill)
- ensure that the decision to prescribe the drug is supported by credible evidence (in relevant medical literature or provided by the manufacturer)
- refrain from advertising or promoting an unapproved drug
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:
- for the first time
- a repeat request for a known patient
- for an anticipated future emergency when the patient is unknown
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:
- its use, safety and efficacy
- the manufacturer
You will not be asked to provide safety and efficacy information:
- for the request of a drug that was previously authorized by the EDR program for the same use
- for a drug that has been authorized by the European Medicines Agency or the U.S. Food and Drug Administration for the same use, without any terms or conditions
- unless there are concerns, such as insufficient evidence or potential risks to health, related to the drug that has caused us to cancel its DIN (drug identification number)
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:
- safety and/or efficacy in the intended species
- human safety, including in relation to foods derived from treated animals
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:
- Complete and sign the Emergency Drug Release Pre-Positioning Form (no fee)
- 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
- We may request more information to inform a decision
- If a request is authorized, we will issue a letter of authorization to the requesting manufacturer and the importer
- For pre-positioned drugs:
- we will copy you on EDRs issued to veterinarians for the drug you have pre-positioned, which is when you can sell the drug to the requesting veterinarian. You can't sell the pre-positioned drug beforehand
- when the drug expires, it can no longer be sold or distributed under an EDR authorization
- You must report annually to Health Canada if the requested drug is:
- a medically important antimicrobials for veterinary use on List A and
- present in Canada at the time of its sale (this means the veterinarian is not the importer)
If this is the case, provide information on:
- the total quantity sold or distributed
- the approximate quantity sold or distributed for each intended animal species
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:
- ensure they have the information needed about the drug so they can submit their EDR request
- verify they can access the needed amount of the drug
When submitting the pre-positioning request for a drug:
- give details about the anticipated medical emergency and the drug to be imported, and the reason for the request
- identify a Canadian importer who holds an establishment licence (EL) in Canada and who can store the pre-positioned drug in a Canadian facility (an EL cannot be requested solely for the purpose of importing a drug for an EDR request)
You must also:
- ensure the quantity of drug imported does not exceed the quantity specified in the EDR letter of authorization
- maintain complete and accurate records of all transactions so that you can reply quickly to our questions or requests
- refrain from advertising or activities deemed to promote an unapproved drug, which are prohibited
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
Email: edr-dmu@hc-sc.gc.ca
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