Regulating veterinary drugs

On this page

• Approving veterinary drugs
• Monitoring safety and quality
• Considering the environment
• Creating policies and setting standards
• Promoting careful use of veterinary drugs
• Promoting and enforcing compliance
• Collaborating with partners
• Engaging and informing Canadians
• For more information

Approving veterinary drugs

To sell a veterinary drug in Canada, manufacturers must:

• apply to the Veterinary Drugs Directorate
• provide evidence to demonstrate that the drug will be:
  • safe
  • effective
  • of high quality
• obtain approval and an assigned drug identification number

For a drug to be approved for use, its benefits must outweigh its risks. A veterinary drug is approved for sale in Canada if the manufacturer has proven that the drug is:

• safe for the animals that will be treated
• safe for humans, if it is to be used in food-producing animals
• effective at treating the condition for which it is approved
• of high quality, by:
  • being manufactured according to strict specifications
  • remaining stable up to its expiry date

Health Canada reviews product labels to make sure they are clear and concise, and include the required information.

All veterinary drugs approved for sale in Canada are listed in the Drug Product Database.

When warranted, Health Canada may allow manufacturers to sell certain drugs that are not authorized for sale in Canada to:

• veterinarians for emergency use
• qualified investigators for clinical trials or scientific research projects

Monitoring safety and quality

Once new veterinary drugs are approved for sale in Canada, we monitor them to ensure:

• their safety and efficacy for animals
• the safety of humans who will:
  • handle these products
  • eat food that comes from treated animals

Manufacturers are required to report all suspected and serious adverse drug reactions. An adverse reaction (side effect) is an unintended reaction to a drug that results in adverse symptoms.

Veterinarians and technicians are the first point of contact for adverse reaction reporting in clinical practice. We encourage them to report adverse reactions to the manufacturer or Health Canada.

Through the Chemicals Management Plan, we assess and take action on potentially harmful chemical substances, including those that may be found in veterinary drugs.

Creating policies and setting standards

Health Canada has developed several guidance documents. These help stakeholders familiarize themselves with the requirements for veterinary drugs outlined in the Food and Drug Regulations.

Regulatory policies and guidance documents are periodically updated and published online.

Promoting careful use of veterinary drugs

Health Canada works to prevent public health issues arising from the use of unauthorized drugs. To do this, we oversee the:

• importation of unapproved drugs for animals
• importation and quality of active pharmaceutical ingredients for veterinary use

We take action to promote the responsible use of antimicrobial drugs, including:

• reviewing and approving all new antimicrobial drugs used in animals
• monitoring the safety of marketed products
• updating product labelling with new information as it becomes available, including information related to antimicrobial resistance

Promoting and enforcing compliance

Health Canada makes sure companies and products are meeting Canada's high safety and quality standards. We do this by promoting, monitoring and enforcing compliance with laws and regulations.

We conduct inspections and carry out targeted or planned reviews of specific product types to monitor compliance. If a company fails to comply, we have a range of options to enforce compliance.

We post information on our compliance and enforcement activities, such as:

• advertising complaints
• a drug and health product inspections database, which allows you to:
  • search for inspection results
  • browse lists of inspections in Canada and at foreign sites

Collaborating with partners

Health Canada helps to protect your health by working with a wide range of partners and stakeholders, including:

• veterinarians
• pharmacists
• manufacturers
• feed mills associations
• importers and distributors
• food animal producers and farmers
• other federal and provincial/territorial partners
• international counterparts

Engaging and informing Canadians

Health Canada engages and informs Canadians on important issues related to veterinary drugs. We are committed to transparency and public involvement as an integral part of decision-making and quality oversight. To do this, we:

• engage with stakeholders
• meet with our advisory committees