ARCHIVED - The Veterinary Drug Approval Process

Questions

1. Under what conditions is a veterinary drug approved for sale in Canada?
2. Can I find out from the VDD what drugs are currently going through the approval process?
3. Does a veterinary drug sold in another country automatically become available in Canada?
4. If I know of a drug that would be useful in a certain situation, but is not yet approved for sale in Canada, can I get permission to use it?
5. How is the sale of new veterinary drugs regulated in Canada?
6. How does the Veterinary Drugs Directorate ensure that food products do not contain harmful levels of drug residue?
7. What information is required on the label of a veterinary drug?
8. What is the VDD's policy on off-label use?
9. Where are the Food and Drugs Act and Regulations?
10. How do I find out if a veterinary drug or medical device has been approved in Canada?
11. How do I know if my product is an old or a new drug?
12. What veterinary drug products are on the market?

Answers

1. Under what conditions is a veterinary drug approved for sale in Canada?

A veterinary drug is approved for sale in Canada if the manufacturer has supplied evidence that the drug:

• is safe for the animals to be treated;
• is effective treating the condition for which it is to be marketed;
• will not pose any demonstrable health hazard to humans eating the food product from treated animals, when the drug is used according to label directions, and
• is manufactured according to strict specifications and remains stable up to its expiry date.

2. Can I find out from the VDD what drugs are currently going through the approval process?

No. All submissions to the VDD for the approval of a drug are confidential. On a weekly basis, the Therapeutic Products Directorate publishes a listing of the drug products that have received a Notice of Compliance (NOC) for products classified as 'new drugs'.

3. Does a veterinary drug sold in another country automatically become available in Canada?

No. Every veterinary drug sold in Canada must first be approved by the VDD and issued a DIN. However, in special circumstances (medical emergencies), the veterinarian may ask the VDD to authorize the sale of a limited quantity of an unapproved drug to the veterinarian for use in a specific emergency.

4. If I know of a drug that would be useful in a certain situation, but is not yet approved for sale in Canada, can I get permission to use it?

The Emergency Drug Release Program allows veterinarians to obtain limited quantities of drugs not approved for sale in Canada for the emergency treatment under their direct medical supervision. Veterinarians may ask the VDD, which may then recommend to the Health Protection Branch, that the manufacturer be authorized to sell them a limited quantity of the drug for emergency use. The manufacturer must provide adequate evidence to the VDD that the drug poses no known health risk to the animals being treated or to humans. The veterinarian assumes full responsibility for the safety of the animals treated and for any drug residue violations in food-producing animals.

5. How is the sale of new veterinary drugs regulated in Canada?

Drug manufacturers must apply to the Veterinary Drugs Directorate for permission to sell a drug in Canada. The manufacturer must provide the evidence required by the VDD to demonstrate that the drug will be safe and effective. All new veterinary drugs must be approved by the VDD and assigned a Drug Identification Number (DIN) before they can be sold in Canada.

6. How does the Veterinary Drugs Directorate ensure that food products do not contain harmful levels of drug residue?

The VDD establishes a specific withdrawal period for each new drug it approves. The withdrawal is treatment-free period before an animal, or food products taken from the animal, can be used for human consumption. This time allows the drug and its residues to decrease to levels that do not pose any demonstrable health risk to humans eating the food. The withdrawal period is stated on the drug label along with other instructions for proper use of the drug.

In addition, federal and provincial food inspection systems monitor food regularly for drug residue violations.

7. What information is required on the label of a veterinary drug?

The label must contain the name of the drug, the Drug Identification Number, the words "For Veterinary Use Only" and warnings and cautions about health hazards for humans and animals, either through direct contact with the drug or through residues in food products.

In addition, the label must include the manufacturer's name and address, the production lot number, a list of medicinal ingredients, an expiry date and adequate directions for the use of the drug.

8. What is the VDD's policy on off-label use?

Off-label use of any drug should be avoided whenever an approved product is available. Veterinarians who choose to make use of a drug in an off-label manner are responsible for the safety of the animals being treated and for any illegal drug residues that are detected in animals and animal products sold for human consumption.

9. Where are the Food and Drugs Act and Regulations?

The Food and Drugs Act and Regulations are available on the Food Program Website.

10. How do I find out if a drug or medical device has been approved in Canada?

Go to the Notices of Compliance page to see recent NOC's, either for Drugs or Medical Devices. More information on NOC's, as well as who to call if you require further help is available on those pages.

For a list of all drugs approved in Canada go to the Drug Product Database.There is currently no online database of Medical Devices on the Canadian market, for more information contact the Device Notification Section at (613) 957-1909.

11. How do I know if my product is an old or a new drug?

The definition of a new drug is found in section C.08.001 (a)(b)(c) of the Food and Drug Regulations. Any product which doesn't fall under this definition is regulated as a Not-New Drug ('old drug').

This link will bring you to a list of pharmaceutical ingredients (also called active or medicinal ingredients) which have been deemed by the Veterinary Drugs Directorate to be "new drugs". A drug which contains one or more of the pharmaceutical ingredients on this list will be regulated as a "new drug", as per section C.08.001 (a). There are other factors besides the active ingredient which affect the status of the drug, including new combinations of drugs, new claims, different dosage forms or routes, etc. Each drug submission is evaluated by the Veterinary Drugs Directorate to determine new vs. not-new status.

12. What veterinary drug products are on the market?

There are several useful web links with this information.