This is an application for judicial review of a decision issuing a Notice of Deficiency- Withdrawal (NOD-W) in response to a Supplemental New Drug Submission (SNDS). The decision under review related to the inclusion of two clinical studies. Health Canada refused to include the studies in the Product Monograph.
The Court considered a preliminary issue of whether additional evidence could be filed before the Court. The Court refused to allow the additional evidence, which consisted of an affidavit attaching a transcript of an examination for discovery on the basis that discovery is confidential.
The Court held that there was no reviewable error by the Minister of Health in rejecting the SNDS. Further, the Court held that the Minister of Health did not commit a breach of procedural fairness.