Topics
	Adopted VICH Guidelines

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 right of your screen.

• Component Checklist for Veterinary New Drug Submissions
  
  
• Guidance Document on Cost Recovery - Veterinary Drug Submission Evaluation Fees
  
  
• Guidance for Industry - Management of Regulatory Submissions
  • Cover Letter
  • Frequently Asked Questions
  • Policy
    
    
• Guidance for Industry Preparation of Veterinary New Drug Submissions
  
  
• Guidelines for Evaluation of Safety and Efficacy of Teat Dip Formulations
  
  
• Information Regarding Payment Procedures
  
  
• Notice of Intent to Adopt the Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients (ICH Topic Q7A) for APIs destined for veterinary use
  
  
• Structure of a Veterinary New Drug Submission
  
  
• Veterinary New Drug List
  
  
• Veterinary Drugs Directorate Draft Guidance - Priority Review Of Veterinary Drug Submissions
  
  
• Veterinary Drugs Directorate Peer Review of Veterinary Drug Submissions
  
  
• Veterinary Drugs Annex to Current Edition of the Good Manufacturing
  
  
• Practices Guidelines - November 2002