Veterinary drug experimental studies

Experimental studies certificates

Experimental studies certificates (ESCs) may be issued by Health Canada to support the conduct of a variety of veterinary drug studies in Canada, as further described below. Through the ESC application process, we provide guidance on how to comply with the regulations, and take animal and human health and safety into account.

Who can apply

Health Canada authorizes the sale (or import for sale) of veterinary drugs to investigators who conduct experimental studies in animals. Investigators can 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 in Canada. Examples of a new veterinary drug are:

a novel active substance
a new indication, route of administration, formulation or for a new species of a previously approved drug

You do not need to apply for an ESC if:

You are conducting a study outside of Canada.
You are using a Health Canada-approved drug in accordance with its authorized label.
You are doing basic science research (often called fundamental or bench research):
- an example would be to discover the function or basic properties of molecules.

As part of our risk-based approach to regulating veterinary drugs, Health Canada may consider ESC requirements a low priority for enforcement if you are conducting a study early in product development. This includes studies that involve:

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 or humans

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:

Complete and sign the Experimental Studies Certificate (ESC) Application Form. The form gives you a checklist of what to submit (such as objectives and outline of the study, drug and supplier information, qualifications of the proposed investigator, rationale for the proposed quantity of the drug), as well as detailed instructions and important information about fees.
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, refer to the guidance 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, 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

Suspending or cancelling an ESC

Health Canada has the regulatory ability to suspend (for a definite or indefinite period) or cancel an ESC in circumstances considered necessary in order to safeguard animal health or public health or to promote public safety.

Other examples can include if:

The submitted ESC application form contains untrue information
The labelling is false, misleading, deceptive or incomplete
The qualifications of the investigator are found to be inadequate, or there is evidence that the investigator has not followed their responsibilities (e.g. reporting all serious adverse drug reactions)

Health Canada takes a risk-based approach when deciding how to respond to issues and concerns. The level of intervention depends on the seriousness of the situation. For example:

For less serious issues (that pose a lower risk to health and safety), we typically begin by reaching out to the investigator to communicate the concern and encourage corrective action
If the issue remains unresolved, we may escalate by suspending the related activity
In cases where serious problems persist, we may cancel the ESC if necessary

In such cases where an issue arises, we would:

Send a notice to the investigator that sets out the concerns or reasons for the intended suspension or cancellation
Provide the investigator with an opportunity to be heard
If the investigator is unable to address the concerns, take a risk-based approach on the decision to suspend or cancel the ESC, and send the investigator a notice that sets out details (such as the effective date and whether a suspension would be for a definite or indefinite period of time)
Reinstate the ESC, for example, if the investigator is able to provide information demonstrating that the situation has been corrected

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, 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, 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 with documentation 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

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2026-07-09

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