Reconsideration Decisions: Drugs

Health Canada's Summary Basis of Reconsideration Decision (SBRD) documents outline the scientific and regulatory considerations that factored into Health Canada's decision to grant or deny a Request for Reconsideration filed as per the Health Canada Guidance Document: Reconsideration of Final Decisions Issued for Human Drug Submissions. The SBRD documents are prepared to inform stakeholders of decisions made, without disclosing potentially confidential information about a submission that may not have received authorization.

SBRD documents should be read in conjunction with the relevant sections of other applicable guidance documents.

• Summary Basis of Reconsideration Decision – Reconsideration of a Notice of Non-Compliance Withdrawal [2012-10-22]
• Advance Consideration under the Notice of Compliance with Conditions Policy
  [2007-06-08]
• Reconsideration of a Notice of Non-Compliance Withdrawal
  [2007-12-20]