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June 24, 2005
Subject: Guidance for Industry - Management of Regulatory Submissions
Dear Stakeholder:
Thank you for your feedback on the Veterinary Drugs Directorate's (VDD's) Guidance for Industry - Management of Regulatory Submissions. Your comments have been reviewed and were taken into consideration prior to the finalization of this guidance document.
This guidance document has been developed to assist submission sponsors in complying with Health Canada policies and governing statutes and regulations. It is also the result of an extensive effort to re-engineer and optimize internal processes in a continuing effort to reduce the backlog and provide timely access for Canadians to safe and effective veterinary drug products. The final version of VDD's Guidance for Industry - Management of Regulatory Submissions has been posted on the Directorate's Web site:
http://www.hc-sc.gc.ca/dhp-mps/legislation/vet/pol/index_e.html
This guidance document is effective July 1st, 2005. If you have any questions or further comments on this guidance document, please contact:
Louis Boulay
Director, Submission and Knowledge Management Division
Veterinary Drugs Directorate
Health Products and Food Branch
Health Canada
Holland Cross Complex,
14 - 11 Holland Avenue
Ottawa, ON K1A 0K9
Or by telephone (613) 957-3884 and/or fax: (613) 946-1125
Sincerely,
Kathy Dobbin
A/ Director General
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