Consultation on VICH Guideline 57
From Health Canada
Current status: The public consultation is now closed. Thank you for your interest.
We are seeking feedback on the draft VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products) Guideline 57: “Studies to evaluate the Metabolism and Residue Kinetics of veterinary drugs in food-producing species: Marker Residue Depletion studies to establish product withdrawal periods in aquatic species.”
The purpose of this guideline is to give recommendations on:
- How to design a study to determine the concentration of a veterinary drug that remains in the tissues (drug residue) of aquatic species after administration of the drug
Join in: How to participate
Send us an email
Send an email to consultationVDD-DMV@hc-sc.gc.ca with your comments.
Participate by mail
Send a letter with your input to the address in the contact information below.
Goals of the consultation
As a trilateral (EU-Japan-USA) program, VICH is aimed at:
- harmonizing technical requirements for veterinary product registration
- providing assistance to industry and healthcare professionals on how to:
- comply with the Government of Canada's policies and governing statutes and regulations
- ensure that the policies and guidelines are implemented in a fair, consistent and effective manner
Your comments will be considered on the draft VICH Guideline 57 by the relevant VICH Expert Working Group. They will then update the draft Guideline for eventual implementation in VICH regions, including Canada.
Key questions for discussion
- Do you support future residue depletion studies based on recommendations described in this guideline, for aquatic species?
- Do you have comments on how this guideline should be modified before it moves to the next VICH phase of implementation?
Who is the focus of this consultation?
The Government of Canada will engage with:
- pharmaceutical companies
- healthcare providers
- health partners
- food producers
- other interested parties
- the general public
International Liaison Officer
Veterinary Drugs Directorate
Health Products and Food Branch
Ground Floor, Suite 14 - Holland Cross Complex
11 Holland Avenue
Ottawa, Ontario K1A 0K9
Postal Locator 3000A
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