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:

• Veterinary Drug Experimental Studies Certificate (ESC) Application Form [in effect until March 31, 2020]
• Veterinary Drug Experimental Studies Certificate (ESC) Application Form [in effect April 1, 2020]
• 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)
• Veterinary Drug Submission Application and Fee Form (PDF Version - 757 K) [in effect until March 31, 2020]
• Veterinary Drug Submission Application and Fee Form [in effect April 1, 2020]
• Health Canada 3011: Drug Submission Application Form for Human, Veterinary or Disinfectant Drugs and Clinical Trial Application/Attestation (PDF Version - 657 K) [in effect until March 31, 2020]
• Health Canada 3011: Drug Submission Application Form for Human, Veterinary or Disinfectant Drugs and Clinical Trial Application/Attestation [in effect April 1, 2020]
• Pre-Submission Meeting Request (PDF Version - 863 K)
• Certification: Submissions NDS, SNDS, NC (PDF Version - 413 K)
• Administrative changes – Certification Form for Veterinary Drugs (PDF Version - 679 K)
• Drug Master File (DMF) Application Form (PDF Version - 488 K)
• Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form (PDF Version - 431 K) [in effect until March 31, 2020]
• Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form [in effect April 1, 2020]
• Emergency Drug Release Application and Fee Form [in effect until March 31, 2020]
• Emergency Drug Release (EDR) Application Form [in effect April 1, 2020]
• Emergency Drug Release (EDR) Fee Form [in effect April 1, 2020]
• Suspected Adverse Reaction to Veterinary Drugs

Veterinary drug submission fees

• Method of Payment for Veterinary Drugs [in effect until March 31, 2020]
• Fee Reduction Application for a Veterinary Drug Submission [in effect until March 31, 2020]
• How to Pay Fees [in effect April 1, 2020]

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: 613-941-8845
Facsimile: 613-954-9860
Teletypewriter: 1-800-465-7735 (Service Canada)

Veterinary Drugs Directorate (VDD)
Holland Cross Complex
Ground Floor
14 - 11 Holland Ave
Postal Locator 3000A
Ottawa, Ontario K1A 0K9