Reconsideration of Final Decisions

The Reconsideration process is a formal dispute resolution process that applies to dispute arising between Health Canada and sponsors of human drug submissions. It is intended to be initiated when informal mechanisms have failed to resolve the issue(s).

Following the issuance of a final decision, sponsors may file a Request for Reconsideration according to the process outlined in the Health Canada guidance document Reconsideration of Final Decisions Issued for Human Drug Submissions. The Reconsideration decision will be issued by the Director General of the appropriate Directorate (Therapeutic Products Directorate or Biologics and Genetic Therapies Directorate).

• Reconsideration of Final Decisions Issued for Human Drug Submissions [2015-04-01]
• Request for Reconsideration Template [2015-04-02]