Guidelines

In this Section:

Several guidance documents have been developed to help our stakeholders familiarize themselves with the regulatory requirements of the Food and Drugs Regulations that pertain to veterinary drug submissions.

In addition, Canada has adopted a number of VICH Guidelines that are available in the topics area to the left of your screen.

• Guidance Document: Determining Prescription Status for Human and Veterinary Drugs [2013-06-21]
• Prescription Drug List [2013-06-21]
• Questions and Answers - Prescription Drug List [2013-06-21]
• Consultation on the new Prescription Drug List [2012-12-24]
• Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations
• French-English Lexicon for Standard Labelling Statements
• Guidance Document: Reconsideration of Decisions Issued for Veterinary Drug Submissions
• Guidance Document on Cost Recovery - Veterinary Drug Submission Evaluation Fees
• Guidance for Industry - Management of Regulatory Submissions
  • Policy
• Guidance for Industry - Preparation of Veterinary Abbreviated New Drug Submissions - Generic Drugs
• Guidelines for Evaluation of Safety and Efficacy of Teat Dip Formulations
• Notice - Post-Notice of Compliance (NOC) Changes Guidance Documents
• Veterinary New Drug List
• Annex 4 to the Current Edition of the Good Manufacturing Practices Guidelines - Veterinary Drugs (GUI-0012)