Service Standards for Veterinary Drug Submission Evaluations under the Food and Drug Regulations

Disclaimer: Information on this webpage is provided for illustrative purposes only. The Food and Drug Regulations should be relied upon for specific requirements, including if there are discrepancies between this page and the Food and Drug Regulations.

The Health Products and Food Branch (HPFB) commits to service delivery standards to reach first decision outlined as time in calendar days in the below-noted table:

Service Standards for Veterinary Drugs
Veterinary Drugs Time in Calendar Days
New Drug Submission 300
Abbreviated New Drug Submission 300
Supplemental New Drug Submission 240
Supplemental Abbreviated New Drug Submission 240
Administrative 90
DIN (including changes to DINs) 120
Notifiable Change 90
Experimental Studies Certificate 60
Emergency Drug Release 2

Performance Target

The target for achieving these standards is the average time to reach first decision on a submission within an individual fee line, as shown in the above table.

Performance Results

Annual service performance is measured over the course of the fiscal year (i.e. April 1 - March 31). Performance results for a given fiscal year are published in the Departmental Results Report, which is normally tabled in Parliament and published in the third quarter (October-December) of the following fiscal year.

In 2016-2017, HPFB's actual performance for these submissions were:

Performance Results for Veterinary Drugs
Veterinary Drugs Time in Calendar Days
New Drug Submission 307
Abbreviated New Drug Submission 339
Supplemental New Drug Submission 222
Supplemental Abbreviated New Drug Submission 221
Administrative 41
DIN (including changes to DINs) 102
Notifiable Change 80
Experimental Studies Certificate 83
Emergency Drug Release <2

Applying for Veterinary Drug Submission Evaluations

Context

Division 8, Part C of the  Food and Drug Regulations provides governance on the sale of new drugs in Canada and prohibits the sale of new drugs unless the manufacturer has filed a submission that is satisfactory to the Minister.

Application Process

The Guidance for Industry Preparation of Veterinary New Drug Submissions is meant to assist drug manufacturers (sponsors) with the preparation of a well-structured veterinary drug submission to facilitate its screening and subsequent review by the Veterinary Drugs Directorate of Health Canada (VDD). It should be noted that all requirements in this guidance document may not necessarily apply to every product. Data requirements may vary depending on the drug and submission type for which a submission is filed.

Some sections of this Guidance Document are general in nature. Therefore, this Guidance Document should be used in conjunction with the complete  Food and Drugs Act ("the Act") and  Food and Drug Regulations ("the Regulations"), and with specific Health Canada Policies and Guidance Documents applicable to veterinary drugs. The manufacturers or those filing submissions on their behalf should ensure that all Veterinary Drug Submissions filed with the VDD contain sufficient information in order to satisfy the requirements of the Act and Regulations.

Cost Recovery

The Guidance Document on Cost Recovery Veterinary Drug Submission Evaluation Fees provides guidance on the interpretation of the  Veterinary Drug Evaluation Fees Regulations with a focus on how the fees for the review of all cost-recovered submissions for veterinary drugs will be administered.

Departmental Contacts

To make any general inquiries or comments on the submission process, please contact:

  • Submission and Knowledge Management Division
    Veterinary Drugs Directorate
    Health Products and Food Branch
    Health Canada
    Holland Cross Complex
    Tower A, Ground Floor
    14-11 Holland Avenue
    Ottawa, Ontario K1A 0K9
    Address Locator - 3000A
    Email: vetdrugs-medsvet@hc-sc.gc.ca
    Fax: 613-946-1125
    Contacts Head-Submission Office: 613-941-1667

For inquiries on Drug Identification Number Applications:

  • DIN/EDR Evaluation Section: 613-941-9269
    Fax: 613-946-1125

For Emergency Drug Release Requests:

  • EDR Contact: 613-948-2381
    Fax: 613-946-1125

Additional Information

Service Feedback

Dispute prevention and early resolution are key to minimizing the impacts of disputes both internally and externally, and to improving relations between Directorates and their stakeholders. HPFB will make every effort to identify, manage, and resolve disputes at the level at which they take place.

Details on the appeal procedure in the veterinary drug evaluation process may be found in the Guidance Document: Reconsideration of Decisions Issued for Veterinary Drug Submissions.

For feedback on service, including on service standards, please send correspondence to the departmental contact indicated above.

For More Information

To learn about upcoming or ongoing consultations on proposed federal regulations, visit the  Canada Gazette and  Consulting with Canadians websites.

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