Important Changes to Health Canada’s Regulatory Enrolment Process (REP)
By: Teri Dickinson, Regulatory Affairs Group Manager, email
As of October 1, 2020, all companies submitting regulatory information to Health Canada for hard surface disinfectants and other drug products are required to submit via the Regulatory Enrolment Process (REP).
REP consists of web-based templates that capture information in a structured format. The REP Regulatory Transaction (RT) and Product Information (PI) templates replace existing Health Canada forms such as the HC-SC3011 drug submission application form and drug submission application fee form.
To be able to file a regulatory transaction both a Company ID and Dossier ID are required to submit information via the Common Electronic Submission Gateway (CESG).
Is your company struggling to sign up for the CESG or need help correctly indexing in non-eCTD format for REP?