VICH guideline 56: Studies to evaluate the Metabolism and Residue Kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing MRLs and withdrawal periods (step 4).

 

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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, New Zealand and South Africa) 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 41 of the VICH guidelines for implementation in Canada.

This guideline is intended to provide study design recommendations which will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements in order to establish appropriate Maximum Residue Limits (MRLs) or other safe limits in honey following the treatment of honeybees with veterinary drug products, or to justify withdrawal periods in honey for registration purposes when an MRL already exists.

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This consultation is open for comment starting February 17, 2017 until April 3, 2017. Please select and read through the link below titled "Letter to Stakeholders". Once read please submit your comments via email or by mail to:

Interested parties are encouraged to provide comments and suggestions by April 3, 2017.

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