Forms – Applications and submissions – Veterinary drugs

This section provides tools and information needed to help veterinary drug sponsors comply with the Food and Drugs Act and Regulations.

Health Canada regulates veterinary drugs used in food-producing and companion animals to ensure that they are safe, effective and of high quality. Learn more about regulating veterinary drugs.

Veterinary Application / Submission Forms:

• Product Classification Request Form - Veterinary Drugs Directorate (VDD)
• Veterinary Drug Experimental Studies Certificate (ESC) Application Form
• Certified Product Information Document (CPID) (Word Version - 121 K)
• Quality Overall Summary - New Drug Submissions/Abbreviated New Drug Submissions (VDD QOS (NDS/ANDS)) (Word Version - 277 K)
• Master File Application Form [2024-01-02]
  Download V1.0 stylesheet ZIP file [2023-06-26]
• Veterinary Drugs Submissions Applications and Fee Form [in effect as of April 1, 2024]
  • Veterinary Drugs Submissions Applications and Fee Form [in effect until March 31, 2024]
• Health Canada 3011: Drug Submission Application Form for Human, Veterinary or Disinfectant Drugs and Clinical Trial Application/Attestation
  Please note that, as of October 1, 2022, the 3011 should no longer be used for applications for pharmaceutical, biologic and radiopharmaceutical drugs for human and veterinary use as well as disinfectants, pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations. Instead, please use the Regulatory Enrolment Process.

  (DOC Version - 228 KB)

• Pre-Submission Meeting Request (PDF Version - 863 K)
• Submission Certificate for a NDS, SNDS, SANDS, ANDS, or NC

  (DOC Version - 42 KB)

• Administrative changes - Certification Form for Veterinary Drugs (PDF Version - 679 K)
• Post-notice of compliance changes of veterinary drugs: Level III form
• Emergency Drug Release (EDR) Fee Form [in effect as of April 1, 2024]
  • Emergency Drug Release (EDR) Fee Form [in effect until March 31, 2024]

Veterinary drug submission fees

• How to Pay Fees

Guidance and Policies

• Guidance Documents
• Policies
• Right to Sell Veterinary Drug Fees
• Drug Establishment Licencing Fees
• Establishment Licencing Fees (Veterinary Drugs) Regulations

For more information

• Veterinary Drugs - Main page
• Drug Product Database
• Notice of Compliance (NOC) database
• Buying and using drug and health products safely
• Food and Drug Regulations

Contact Us

You can reach the Veterinary Drugs Directorate by:

E-mail: HC.vdd.skmd.so-dgps.dmv.cp.sc@canada.ca
Telephone: 613-321-4239