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Consultation on VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products) guideline 48: Studies to evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-producing Animals: Marker Residue Depletion Studies to establish Product Withdrawal Periods (step 4)
VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products), is a trilateral (EU-Japan-USA) program aimed at harmonizing technical requirements for veterinary product registration. Canada (along with Australia and New Zealand) is an observer country at VICH, and the Veterinary Drugs Directorate (VDD) is the VICH Coordinating Secretariat for Canada. The VICH Guidelines provide assistance to industry and healthcare professionals on how to comply with the Government of Canada’s policies and governing statutes and regulations. They also serve to provide review and compliance guidance internally, thereby ensuring that the policies and guidelines are implemented in a fair, consistent and effective manner. Before VICH guidelines are adopted or moved to the next step in the adoption process, they are usually submitted to each participating country’s industry for consultation and comments on the draft guideline. The VDD has adopted 32 of the VICH guidelines for implementation in Canada.
As part of the approval process for veterinary medicinal products in food-producing animals, regulatory authorities require data from marker residue depletion studies in order to establish appropriate withdrawal periods in edible products including meat, milk, eggs and honey. The objective of this guidance is to provide study design recommendations which will facilitate the universal acceptance of the generated residue depletion data to fulfill this requirement.
How to Get Involved
This consultation is open for comment starting March 17 until April 20, 2010. Please select and read through the link below titled "Letter to Stakeholders". Once read please submit your comments via email or by mail to:
consultationVDD-DMV@hc-sc.gc.ca
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
Interested parties are encouraged to provide comments and suggestions by April 20, 2010.
Reporting to Canadians
Health Canada will make the results of this consultation available on this Web site.
If you have any questions, contact us at: consultationVDD-DMV@hc-sc.gc.ca
