Veterinary drug experimental studies

Learn about conducting veterinary drug experimental studies in animals. Find information on how to meet the requirements of the Food and Drug Regulations.

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Who can apply

Health Canada authorizes the sale (or import for sale) of veterinary drugs to investigators who conduct experimental studies in animals. Investigators include:

About the application process

You may apply for an experimental studies certificate (ESC) to conduct a study of a new veterinary drug in animals. Examples of a new veterinary drug are:

The following are examples of when you should apply for an ESC:

The following are examples of when not to apply for an ESC:

As part of our risk-based approach to regulating veterinary drugs, Health Canada will not enforce the ESC requirements if you are conducting a study early in product development without an ESC. This includes studies that involve:

If you need more information or clarification, such as if you may wish to seek an ESC for other purposes (for example, wildlife immobilization or management), email us at

How to apply

To apply, follow these steps:

  1. Complete and sign the Experimental Studies Certificate (ESC) Application Form (the form gives detailed instructions and important information about fees).
    • include the following information at a minimum:
      • nature of the study
      • drug and supplier information
      • qualifications of the principal investigator
      • facility where the study is conducted
      • rationale for the quantity of drug being requested
      • summary of evidence concerning risk and risk mitigation for human and animal health
      • experimental drug label (as per C.08.016 of the Food and Drug Regulations)
      • toxicity and residue data if for food-producing animals
  2. Send your completed application and attachments to the Veterinary Drugs Directorate (VDD) by email at

After you apply

We may ask for more information to help us make a decision on your application.

If we approve your application, we will issue you an ESC. The certificate will indicate the quantity of the drug that you may use for the study.

If you are importing the study drug, a copy of the ESC should accompany the shipment to allow timely entry of the drug into Canada.

For information on importation, please refer to the guidance document on veterinary drugs and veterinary health products. You may also contact us by email at

After you receive your ESC, if you intend to make any changes, you must contact us by email so we can determine if an amendment to your ESC is needed:

Your responsibilities

Before you begin your study, you should:

When conducting your study, you should:

Other authorizations

Cannabis and controlled substances

Depending on the drug used in your study, you may need to obtain other authorizations from Health Canada before you begin. Examples include:

Protocol review

You may also ask for a protocol review by VDD. We charge a fee for this service.

Veterinary drug manufacturers or researchers often seek protocol reviews when they want an in-depth review of the study design to support a future regulatory submission for market authorization in Canada. This includes studies that may take place in another country.

For more information, contact us by email at

Other oversight mechanisms

For other important guidelines, standards and requirements for studies in Canada that use animals, please refer to the following:

If you intend to import a veterinary drug for research purposes that does not require an ESC, you should be prepared to:

For more information, email us at

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