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Notice

Final guidance document: Reconsideration of Decisions Issued for Veterinary Drug Submissions

June 18, 2009

The final version of the Health Canada guidance document Reconsideration of Decisions Issued for Veterinary Drug Submissions is now available. This guidance is a revised version of the draft published for consultation in February, 2007 of the same title. The final guidance document outlines the process for industry and staff regarding requests for reconsideration of decisions and replaces the Health Canada policy: Blueprint for the Veterinary Drug Submission Appeal Process.

Comments received from the consultation on the draft version of the guidance document were reviewed and considered in the finalization of this document.

Should you have any questions regarding the content of the guidance document, please contact the Submission and Knowledge Management Division.

Effective Date

The final guidance document Reconsideration of Decisions Issued for Veterinary Drug Submissions applies to all decisions for submission types within the Scope of the guidance document, Management of Regulatory Submissions (MORS), version 1, which came into effect July 1, 2005.

Decisions issued for submission types within the Scope of MORS

The final guidance document Reconsideration of Decisions Issued for Veterinary Drug Submissions is effective as of June 18, 2009, and will apply to all decisions issued after that date. As of June 18, 2009, the Blueprint for the Veterinary Drug Submission Appeal Process will no longer be in effect and will be removed from the Health Canada website.

Decisions issued for submission types outside the Scope of MORS

As of June 18, 2009, the Blueprint for the Veterinary Drug Submission Appeal Process will no longer be in effect and will be removed from the Health Canada website. Effective June 18, 2009, for decisions for submission types which are outside the Scope of both the Reconsideration of Decisions Issued for Veterinary Drug Submissions and the Management of Regulatory Submissions (MORS) documents (i.e., Experimental Studies Certificate (ESC), Investigational New Drug (IND), Emergency Drug Release (EDR) and Drug Identification Number (DIN)), requests for reconsideration will be considered on a case-by-case basis.

Revisions to Health Canada guidances and policies

Existing Health Canada guidances and policies which require updating as a result of the finalization of the guidance document Reconsideration of Decisions Issued for Veterinary Drug Submissions will be updated at their next opportunity.

Questions related to these guidance and policy documents should be directed to their individual contacts, identified for each document on the Health Canada website.