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:
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:
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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