About veterinary drug submission guidance documents
On this page
- Overview of submission guidance documents
- How to file a submission and the administrative processes
- Seeking market authorization (pre-market)
- After you receive market authorization (post-market)
Overview of submission guidance documents
Health Canada's Veterinary Drugs Directorate (VDD) evaluates and monitors the safety, quality and efficacy of veterinary drugs for food-producing and companion animals. This oversight is based on the requirements in the Food and Drugs Act and the Food and Drug Regulations.
We have developed guidance documents to provide information on how to file veterinary drug submissions and comply with the regulations. These guidance documents reflect the structure, format and content requirements for pre-market and post-market submissions, as well as our administrative and procedural steps.
In the global context, we have adopted international guidelines related to technical requirements for veterinary drug submissions. Our international collaboration page also explains how we work with our regulatory partners for both pre-market and post-market submissions to:
- leverage resources
- facilitate timely access to safe and effective veterinary drugs
- promote harmonization of regulatory practices and standards
We will update the guidance documents periodically to apply a science-based and risk-based approach to the assessment of veterinary drugs. Note that guidance documents are administrative instruments not having the force of law.
How to file a submission and the administrative processes
Companies are required to file submissions electronically, which helps file and process regulatory information, such as submissions. Regulatory enrolment process (REP) is a common submission intake method across health product lines (including veterinary drugs) and filing formats (that is, eCTD and non-eCTD).
Additionally, our management of regulatory submissions (MORS) guidance provides administrative and procedural information about how we manage submissions.
Seeking market authorization (pre-market)
Before a veterinary drug can be sold in Canada, submission applicants must apply for market authorization by providing evidence of the drug's safety, efficacy and quality for our review to obtain approval and an assigned drug identification number. We have developed pre-market guidance documents to help applicants prepare well-structured and high-quality submissions.
Preparing veterinary drug submissions
The Food and Drug Regulations outline the pre-market requirements and provisions for Division 1 drugs, Veterinary Health Products (VHPs), and Division 8 new drugs.
Guidance for Division 1 drugs and VHPs
- Guidance on Division 1 drugs: Preparation of veterinary Drug Identification Number (DIN) submissions
- Guidance on the VHP Notification Program: Veterinary Health Products
Guidance for Division 8 new drugs
The standard submission structure and format is provided in appendices of the guidance documents listed in this section, and also in the zip file folder structure for veterinary drugs.
The following guidance documents are intended to help applicants prepare their submissions:
- Guidance for Industry Preparation of Veterinary New Drug submissions
- This covers administrative requirements, clinical, human safety and quality information.
- Note: information about the quality submission content is now replaced by Guidance for Industry: Preparation of Veterinary New Drug Submissions and Abbreviated New Drug Submissions (New and Generic Drugs) – Quality Requirements
- Guidance for Industry: Preparation of Veterinary New Drug Submissions and Abbreviated New Drug Submissions (New and Generic Drugs) – Quality Requirements
- This covers quality information for new and generic drugs, replacing the previous quality information in the NDS and ANDS guidance documents.
- Guidance for Industry: Preparation of Veterinary Abbreviated New Drug Submissions (Generic Drugs) – Clinical and Human Safety Requirements
- This covers clinical and human safety information for generic drugs, replacing the previous version.
After you receive market authorization (post-market)
The following guidance documents assist applicants in preparing post-market submissions:
- Post-Notice of Compliance (NOC) changes: Guidance for safety and efficacy of veterinary drugs: Overview
- Post-NOC changes: Guidance for quality of veterinary drugs: Overview
- For administrative submissions (amendments) and post-approval administrative submissions: Management of regulatory submissions for veterinary drugs: Guidance : Submission-related processes
Related links
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