Regulatory Enrolment Process (REP)

The Regulatory Enrollment Process (REP) is a streamlined framework designed to simplify the submission and processing of regulatory information for companies, dossier products, regulatory activities, and transactions. Recent updates to the REP include the removal of specific text references and the ability to capture a broader range of information through the Common Electronic Submission Gateway (CESG).

At its core, the REP leverages web-based templates to collect structured information, effectively replacing traditional Health Canada forms such as the HC-SC3011 drug submission application form and the human drug submission application fee form. This approach standardizes submission intake across product lines, enabling Health Canada to seamlessly receive a wider spectrum of regulatory information via the CESG and automate the integration of regulatory transactions into its repositories.

Region: Canada

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process.html