Emergency Drug Release (EDR)

What is an Emergency Drug Release (EDR)?

An Emergency Drug Release is an authorization, under the provisions of Sections C.08.010 and C.08.011 of the Food and Drug Regulations, to permit the manufacturer of a new drug to sell a limited quantity of the new drug to a veterinary practitioner.* The new drug is one which is not marketed in Canada and is requested by the practioner for the purpose of diagnosing or treating a medical emergency in a patient under his or her care.

What information does VDD require for authorization of an EDR?

The practitioner must supply the VDD with information concerning the emergency (including animal species, production type, age, disease state or situation requiring treatment, number of animals to be treated), data in his possession respecting the safety, efficacy and human safety (withdrawal times/residue data, occupational safety) of the drug, and information on the amount of drug required, route of administration, dosage and concentration of the drug.

How does a veterinarian request an EDR?

A practitioner may request an EDR by completing the Emergency Drugs Release Application and Fee Form and faxing it to the Veterinary Drugs Directorate (VDD) at (613) 946-1125.

What is the practitioner's responsibility?

The practitioner assumes full responsibility for the use of this new 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 from where the drug can be obtained, the dosage, indications and contraindications, and is responsible to provide the above information to the VDD.

The practitioner must report to the manufacturer and to the VDD on the results of the use of the new 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 received. This follow up report must be prepared and submitted to the VDD to permit authorization of additional drug releases.

* 'Practitioner' means a person who is registered and entitled under the laws of a province to practice the profession of veterinary medicine.