Consultation on VICH Guideline 58

From Health Canada

Current status: Closed

This 60-day consultation period ran from August 10 to October 9, 2018.

We are seeking feedback on the draft VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products) Guideline 58 : “Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV (step 4).”

The VICH is a trilateral (EU-Japan-USA) program aimed at harmonizing technical requirements for veterinary product registration and was officially launched in April 1996. The VICH plays a central role in facilitating the global registration of veterinary medicinal products, while establishing and maintaining consumer confidence in the quality, safety and efficacy of these products. Canada is an observer country at VICH.

The purpose of this guideline is to:

  • detail the core stability data package needed for new veterinary drug substances and medicinal products while maintaining flexibility to reflect the specific scientific considerations and characteristics of the materials being evaluated

Join in: How to participate

Send us an email

Send an email to with your comments.

Participate by mail

Send a letter with your input to the address in the contact information below.

Goals of the consultation

By implementing the VICH guidelines, the Veterinary Drugs Directorate aims to:

  • harmonize technical requirements for veterinary product registrations
  • provide assistance to industry and healthcare professionals on how to comply with the Government of Canada's policies and governing statutes and regulations

Your comments will be considered on the draft VICH Guideline 58  by the relevant VICH Expert Working Group. They will then update the draft Guideline for eventual implementation in VICH regions, including Canada.

Key question for discussion

  • Do you have comments on how this guideline could be modified before it moves to the next VICH phase of implementation?

Who was the focus of this consultation?

The Government of Canada will engage with:

  • pharmaceutical companies
  • healthcare providers
  • pharmacists
  • health partners
  • food producers
  • other interested parties
  • the general public

Contact us

International Liaison Officer
Veterinary Drugs Directorate
Health Products and Food Branch
Health Canada
Ground Floor, Suite 14 - Holland Cross Complex
11 Holland Avenue
Ottawa, Ontario K1A 0K9
Postal Locator 3000A


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