Policy on terms and conditions for veterinary drugs: Notice to stakeholders
Effective date: February 12, 2025
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Background
Terms and conditions (T&Cs) are a tool used to manage known or anticipated risks and significant uncertainties associated with a drug. They also allow certain drugs to be considered for market authorization based on promising evidence of clinical efficacy.
Health Canada consulted stakeholders on the regulatory proposal to introduce T&Cs for veterinary drugs. We published the proposal in the Canada Gazette, Part I in 2022. Following a consultation period, we then published the Regulations Amending Certain Regulations made under the Food and Drugs Act (Agile Licensing) in the Canada Gazette, Part II on December 18, 2024.
The Agile Licensing Regulations introduced amendments to the Food and Drug Regulations so that T&Cs can be used for veterinary drugs. This may mean early market access to promising novel therapies for animals suffering from serious or severely debilitating diseases or conditions.
Implementing T&Cs by policy
The T&C regulatory authorities for veterinary drugs will come into force on April 1, 2027. In the interim, starting April 1, 2025, the Veterinary Drugs Directorate (VDD) is implementing T&Cs by policy for veterinary drugs that meet certain criteria. This will also expand the type of veterinary drugs that may be reviewed simultaneously with the United States to include drugs seeking conditional approval in that country.
Learn more:
The process for managing regulatory submission supported by promising evidence of efficacy is similar to the process described in the Veterinary drugs - Management of regulatory submissions guidance.
Eligibility
This policy applies to new drug submissions (NDSs) and supplements to new drug submissions (SNDSs) for veterinary drugs that are for serious or severely debilitating diseases or conditions and where there is promising evidence of efficacy. It does not apply to veterinary biologics regulated under the Health of Animals Act.
When filing an NDS or SNDS, manufacturers must indicate that their veterinary drug be considered for authorization based on promising evidence of efficacy. The new drug must meet the following 2 criteria:
- the drug treats, prevents or diagnoses a serious or severely debilitating disease or condition and
- the drug either:
- treats, prevents or diagnoses a disease or condition for which no drug is currently authorized in Canada or
- is significantly more effective, or poses a significantly lower risk compared to drugs currently authorized in Canada, or medical procedures or diagnostic methods that are currently available to manage the serious or severely debilitating disease or condition
How to file a submission
Pre-submission requirements
Before you file your submission, you should:
- communicate with us early on about the promising evidence of efficacy for your veterinary drug
- assess your drug's eligibility based on the 2 criteria
- request a pre-submission meeting
- email us at vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca
Your pre-submission package should show that there is promising evidence for your drug and contain the information described in the Veterinary Drugs - Management of Regulatory Submissions Guidance.
An appendix to the pre-submission package should include the following information:
- how the product meets the 2 criteria for promising evidence
- a summary of studies completed to support the promising evidence
- the status of ongoing studies that support the drug's clinical effectiveness, including interim results and anticipated completion dates
- a plan for completing all ongoing studies and
- a timeline for filing the submission based on promising evidence
Your pre-submission meeting package (including the appendix) should be under 40 pages.
You will be notified if your submission will be considered based on promising evidence of efficacy within 14 calendar days after the pre-submission meeting minutes are finalized.
Unless otherwise agreed to in the pre-submission meeting, submissions should be filed within 6 months of receiving this confirmation. Otherwise, a new pre-submission meeting may be required. (Note: A copy of this confirmation should be included in the submission.)
Submission timelines and process
Every effort is made to expedite submissions, but the ability to do so depends on resources.
During a submission review, VDD will inform you of any T&Cs that may be imposed in an "anticipatory terms and conditions letter". You will have 30 calendar days to respond to the letter. We will review your response within 30 calendar days and issue a final "terms and conditions letter" if the submission receives an authorization. This letter will specify the drug identification number (DIN), the T&Cs to be fulfilled, additional information to be submitted and the timeframe for fulfilling the T&Cs.
After a drug is authorized, T&Cs associated with the DIN will be posted online.
Fulfilling T&Cs
Following authorization, the information to fulfill the T&Cs should be filed using the appropriate submission type by the date indicated in the final T&C letter. Once satisfactory evidence is provided and all the T&Cs have been met, the conditions associated with the DIN will be removed.
Any outstanding T&Cs will transition to regulatory T&Cs on April 1, 2027, with more information provided at that time to affected market authorization holders.
For information about general pre-submission requirements, our screening and review timelines, consult the Veterinary Drugs - Management of Regulatory Submissions Guidance.
Contact us
If you have any questions about T&Cs policy for veterinary drugs, contact VDD at vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca.