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.

On this page

• Who can apply
• About the application process
• How to apply
• After you apply
• Other authorizations
• Other oversight mechanisms

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:

• academia
• veterinarians
• research organizations

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:

• a novel active substance
• a new indication, formulation or species of a previously approved drug

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

• You are a researcher or research organization looking to conduct studies in Canada to generate data to support an eventual veterinary drug regulatory submission for market authorization.
• You are a veterinary researcher conducting a trial or research with a veterinary drug and the animals being treated may include animals that are not in your direct care.
• You are conducting studies involving food-producing animals that could enter the food chain.

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

• You are conducting a study outside of Canada.
• You are using a Health Canada-approved drug in accordance with its authorized label.
• You are conducting a study on an animal (for example, mice, rats, pigs, dogs) to develop drugs for human use.
  • You are not using or intending to market the study drug as a veterinary drug.

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:

• basic science research (often called fundamental or bench research):
  • an example would be to discover the function or basic properties of molecules
• research taking place in non-target species:
  • an example would be a study using mice for a drug that's intended for use in dogs

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 vdd.vetdrugs-medsvet.dmv@hc-sc.gc.ca.

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 vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca.

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 hpbcp-pcpsf@hc-sc.gc.ca.

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: vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca.

Your responsibilities

Before you begin your study, you should:

• confirm if other authorizations are needed or if other guidelines or standards may apply
• contact the Canadian Council on Animal Care about standards for animal ethics and care or local authorities for any other province/territory-specific regulations

When conducting your study, you should:

• use the study drug appropriately, taking into account any drug withdrawal times
• not advertise, promote or sell the study drug
• report any serious adverse drug reactions right away

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:

• if you are conducting research involving cannabis, your research may be subject to the Cannabis Act
• for details about the cannabis research licensing process, contact us at sp-licensing-cannabis-licences-sp@hc-sc.gc.ca
• if you are conducting research involving controlled substances, your research may be subject to the Controlled Drugs and Substances Act (CDSA)
• researchers requiring a controlled substance for research purposes must receive an exemption under subsection 56(1) of the CDSA
• for details about the exemption process, please refer to exemptions from the provisions of the CDSA or contact us at exemption@hc-sc.gc.ca

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 vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca.

Other oversight mechanisms

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

• Good clinical practice - Guideline 9 (VICH)
• Good laboratory practices for test facilities and their management for non-clinical studies (OECD)
• Three Rs and ethics (Canadian Council on Animal Care)

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

• justify the quantity being imported and
• explain how the research being undertaken falls outside the scope of an ESC

For more information, email us at hpbcp-pcpsf@hc-sc.gc.ca.

Related links

• Health Canada 3011 form – For manufacturers: Veterinary investigational new drug
• Clinical trial applications (CTAs) for human drugs
• Regulating veterinary drugs, considering the environment