Emergency Drug Release Application and Fee Form

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VETERINARY DRUGS DIRECTORATE
Holland Cross Complex, Tower A, Ground Floor, AL 3000A
14-11 Holland Avenue, Ottawa ON K1A 0K9
Tel: (613) 948-2381 Fax: (613) 946-1125

Please note the following information and procedures concerning application and cost recovery fees for Emergency Drug Releases.

The attached form must be fully completed for each Emergency Drug Release (EDR) Request and faxed/mailed to the Veterinary Drugs Directorate.

Please photocopy this form for future use.

Procedure

1. One EDR must be requested for each patient.
   Eg. A patient means one pet animal or one horse or one herd or one group of 300 sows or one group of zoo animals/wildlife or one site of fish.
   
   
2. You may request a sufficient quantity for one patient for:
   a) up to 6 months of treatment ie. in the case of patients requiring chronic therapy
   or
   b) a specific course of treatment for one patient, up to a maximum of 6 months
   
   
3. >You must indicate the date(s) when you plan to use the drug, when the animal(s) will be treated, and clarify that the amount you are requesting is sufficient for maximum of six months.
   
   
4. A follow-up report must be received in order for further authorization to be given. This follow up report may accompany your request (the attached form) or you may indicate that you have previously sent it or the date that you plan to send it.
   
   
5. An EDR for a non food animal is $50.00.
   An EDR for a food animal is $100.00.
   You will be invoiced by Health Canada.
   
   
6. For animals such as elk, bison, or domestic animals used in research, ie any species which could potentially enter the human food chain, you must provide a statement that the animal(s) in which the drug is being used will not enter the human food chain; or, you must indicate that the animals may enter the food chain; for some emergency drugs, the Directorate may have an evaluation of withdrawal time on file, otherwise you are required to provide us with metabolism/residue studies such that we can evaluate a withdrawal period.

Once the EDR request has been processed, you will be charged and invoiced even if you subsequently decide to cancel or modify your request.

The role of the Veterinary Drugs Directorate is to authorize the manufacturer of a new drug to sell it to a practitioner for 'emergency use' prior to its approval in Canada. Once your request is received, it is processed in our office and faxed to the manufacturer, normally within the end of the following business day; you should contact the manufacturer appropriately for information on the drug itself, cost, protocol for use, shipping, payment for the drug etc.

Form Information

Manfacturer Name & Address

Telephone   Fax

Contact

Drug Brand Name & Strength

Active Ingredient

Quantity requested

Clarify maximum for 6 month

Date(s) drug will be used

Dosage & Route of Administration

Veterinarian Practitioner Name & Address

Telephone   Fax

Email

Billing address (if different)

Billing contact person

Veterinary Situation   Disease
Justification

Species

Number of animals   age  weight  sex

Animal's name and Owner's name (for pets and horses)

Animal's name

Owner's name

Producer's Name and Address (for farms and /orbreeding units)

Production Site (for aquaculture)

Previous follow up report: has been sent   is attached
other (explain)

If applicable, please provide a written statement that animals to which this drug is administered will not be used in food for human consumption.

An EDR for a non food animal is $50.00; for a food animal is $100.00: you will be invoiced by Health Canada for your EDR request.

VETERINARIAN'S SIGNATURE:
DATE:

HC use only

Customer no.  EDR no.  NF  F

Invoice no. _______ S.O.no _______