Emergency Drug Release (EDR)
What is an Emergency Drug Release (EDR)?
Health Canada's Emergency Drug Release (EDR) program is supported by sections C.08.010 and C.08.011 of the Food and Drug Regulations. The EDR program considers requests for access to drugs for veterinary use:
- that are unavailable for sale in Canada; and,
- that are submitted by veterinary practitioners, for the purpose of diagnosing or treating a medical emergency in a patient (or group of animals) under their care.
A veterinary practitioner means a person who is registered and entitled under the laws of a province to practice the profession of veterinary medicine.
What information does Health Canada require for the review of a request for an Emergency Drug Release?
The veterinary practitioner must supply the Health Canada’s Veterinary Drugs Directorate (VDD) with information concerning:
- the medical emergency including:
- animal species
- production type
- disease state or situation requiring treatment
- number of animals to be treated etc.
- data in their possession respecting the safety, efficacy and human safety:
- withdrawal times/residue data
- occupational safety of the drug.
- information on the amount of drug required, route of administration, dosage and concentration of the drug.
How does a veterinary practitioner request an Emergency Drug Release?
What is the veterinary practitioner's responsibility?
- The practitioner assumes full responsibility for the use of a non-marketed drug with respect to safety and efficacy in the intended species and drug withdrawal times relative to potential residues in food derived from treated animals.
- The practitioner should know:
- the name of the manufacturer from where a non-marketed drug can be obtained as well as the dosage, indications and contraindications
- that it is their responsibility to provide the above information to the VDD.
- The practitioner must agree to report to the manufacturer and to the VDD on the results of the use of a non-marketed drug in the medical emergency, including information respecting any adverse reactions encountered. The report should be in some detail, indicating use and efficacy, and should account for all quantities of the drug authorized by the VDD. This follow up report must be prepared and submitted to the VDD to permit authorization of additional release for the same drug.
For more information, please contact:
Veterinary Drug Directorate
Holland Cross Complex, Tower A, Ground Floor, AL 3000A
14-11 Holland Avenue, Ottawa ON K1A 0K9
Fax: (613) 946-1125
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