The Veterinary Drugs Directorate is responsible for evaluating drugs for use in animals to determine that veterinary drugs are safe and effective and that food derived from treated animals does not contain potentially harmful residues.

The Directorate is part of the Health Products & Food Branch (HPFB). The VDD ensures safety of foods such as milk, meat, eggs, fish and honey from animals treated with veterinary drugs. They also ensure that veterinary drugs sold in Canada are safe and effective for animals.

The Directorate is comprised of seven divisions:, including the Human Safety Division, which evalutes data on new drugs to asses any potential hazards to human health resulting from the use of veterinary pharmaceuticals in animals used for food.

A drug manufacturer may only sell a drug in Canada if a submission has been filed with Health Canada and a Drug Identification Number issued.

When is approval given?

Veterinary drugs are used to prevent and treat diseases in animals caused by micro-organisms and parasites. Some drugs may help to promote growth, control reproduction or provide humane means of restraint and relief of pain in animals.

A new veterinary drug is approved for sale in Canada only if Health Canada is satisfied that:

• the drug is safe for the animals to be treated and effective for the purpose it is being marketed;
• it does not leave potentially harmful residues that could pose any health hazard to humans eating food products from treated animals (meat, milk, eggs, fish and honey);
• the drug must be manufactured according to strict specifications and must remain stable up to its expiry date.
  

The Drug Review Process

The review of a veterinary drug is the same as for any drug, whether produced by traditional methods or by biotechnological means.

It must undergo rigorous scrutiny and fully satisfy all scientific requirements under the Regulations to the Food and Drugs Act - Part C.

Non-scientific issues, such as social and economic matters, are not part of the scientific review.

For a new drug to be reviewed, the manufacturer must:

• submit a New Drug Submission which contains details of manufacturing and quality control as well as results of toxicity, pharmacology, residue and clinical studies;
• provide the VDD with substantial evidence to support the product's quality, safety and efficacy;
• prove that proposed labels for the new drug reflect the data submitted and specify adequate directions for use, including withdrawal periods for drugs used in food-producing animals.
  

Manufacturers must also submit information, in a Supplemental New Drug Submission, if they wish to make significant manufacturing changes or modify conditions of use (labelling) for previously approved drugs.

If required, the VDD will ask for further information. This process continues until the VDD approves or rejects the application.

Scientists in the Veterinary Drugs Directorate review the claims and findings of a company in the submissions and ensure that the information that will be provided to veterinarians and consumers is clear and unequivocal.

When there is no clear consensus among its scientists, or when the VDD would benefit from outside advice, it will also convene an Expert Advisory Panel to review data and recommendations made by scientists.

If a submission is accepted and the product is approved, the manufacturer will receive a Notice of Compliance from Health Canada specifying the terms and conditions under which the drug can be sold and used. The drug must bear a Drug Identification Number (DIN) on its label.