Pre-submission or Pre-application Meetings
Pre-Submission meetings are not limited to new drug submissions. They can be requested by sponsors before filing a submission/application for any product, including Natural Health Products, Cosmetics, Foods and medical devices. Meetings can be conducted face-to-face or by teleconference with the appropriate Directorate within Health Canada if they have any questions. Also, meetings are held before filing a clinical trial application, a drug submission/application, a request for a combination product classification, a priority review, or a submission for Extraordinary Use New Drugs (EUNDS).