Instructions for Guidance Document

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The draft version of the Health Canada guidance document Draft Guidance for Industry - Preparation of Electronic Submissions for the Veterinary Drugs Directorate is now available. The purpose of this guidance document is to assist sponsors in preparing the electronic components of a drug submission to the Veterinary Drugs Directorate (VDD). Guidance on the structure, content, format and media of electronic information is also provided. It should be noted that electronic filing is not a substitute for the paper submission at this time. Sponsors who choose to file part or all of their submission electronically are still required to submit the full paper copy, as the paper copy continues to be the legal copy.

This draft guidance document is effective immediately, and comments on this draft will be accepted for a period of 60 days, after which point finalization of the document will take place.

Comments and questions regarding the content of this guidance document should be forwarded to vetdrugs-medsvet@hc-sc.gc.ca.