Regulatory Requirements for DIN-issued Products

Health Canada’s Regulatory Enrollment Process (REP)

Posted October 3, 2019

By: Sarah Calder, Regulatory Affairs Specialist, email

Have you received notice from Health Canada regarding the Regulatory Enrollment Process (REP)? Do you know what the REP is?

The REP is a new initiative being rolled out by Health Canada to allow industry an alternate process for submitting regulatory transactions. This new process allows quick and secure transmission of documents in a modernized format. It consists of a set of web-based templates used to collect information from industry related to their company, dossiers, and other regulatory transactions, utilizing XML format. These documents are then submitted through the Common Electronic Submissions Gateway (CESG) for communication with Health Canada.

Before transmitting any transactions using the REP, companies must enroll. All companies must obtain a company ID, even if a company ID exists with Health Canada.

The REP was announced in August 2019 as a voluntary measure to provide industry time to become accustomed to the new program. It is important to note that this submission protocol is currently voluntary, but Health Canada intends to make the Regulatory Enrollment Process mandatory by August 2020.

Benefits of using the Regulatory Enrollment Process (REP):

Easy to update company details
Easy to track regulatory activities
Securely transmit confidential documentation
Capability to submit eCTD and non-eCTD formats
Respond quickly to deficiencies or requests directly to Health Canada.

Connect with our office today for further information on how you can register your company. Dell Tech is ready to assist our clients and future clients in enrollment in the REP and able to submit dossiers, applications, regulatory transactions, etc. using the REP through the CESG.

Contact:
Dell Tech Laboratories
info@delltech.com
519-858-5021