Notice: Mandatory use of the Regulatory Enrolment Process (REP) as of October 1, 2020

Date: March 30, 2020
Our file number: 20-1052634-535

The Health Products and Food Branch (HPFB) is pleased to be implementing a single window for transmission of regulatory transactions in electronic format which is considerably faster and more efficient than courier services and which provides secure transmission of transactions which standard email does not offer. To facilitate the use of this single window, also known as the common electronic submissions gateway (CESG), HPFB has created the Regulatory Enrolment Process (REP). Use of the REP will be mandatory as of October 1, 2020, for pharmaceutical, biologic and radiopharmaceutical drugs for human use as well as disinfectants, pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations.

What is the REP?

The REP is a method HPFB uses to collect information from sponsors related to their company, dossiers, products, regulatory activities and transactions. It consists of a set of web-based templates that upon completion generate REP Extensible Markup Language (XML) files. The REP XML files are sent to HPFB via the Common Electronic Submissions Gateway (CESG). 

The REP will replace the processes for the existing Health Canada 3011: Drug Submission Application Form and the Drug Submission - Application Fee Form for Human and Disinfectant Drugs.

Why use the REP?

The objective of the REP is to implement a common intake approach for all product lines, which includes the following:

Scope of Mandatory REP

Mandatory filing of regulatory transactions using REP will apply to pharmaceutical, biologic, and radiopharmaceutical drugs for human use, as well as disinfectants pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations, that are filed in scope of either eCTD or non-eCTD format.

Sponsors are encouraged to use the REP for clinical trials, veterinary drugs, and medical devices, however, they are currently exempt from this mandatory requirement. Refer to the appropriate REP pilot project described on the REP information page for details.

How to use the REP

Although the use of REP will be mandatory beginning on October 1, 2020, it is highly recommended that sponsors familiarize themselves with the CESG requirements, REP templates and help instructions, as well as the process prescribed in the Guidance Document: The Regulatory Enrolment Process for Drugs for Human Use, as early as possible. Detailed information regarding the REP is available on the REP information page.

The process of registering for and setting up a CESG account, as well as obtaining a dossier identifier (ID) requires some time. Therefore, sponsors are encouraged to begin this process well in advance (e.g. approximately three months) of filing their first regulatory transaction using the REP.

For regulatory activities that are under review post October 2020, sponsors must ensure they are prepared to use the REP should they be required to file a response to a clarification request.

Steps to complete, prior to filing a first regulatory transaction using the REP:

Important considerations about transitioning dossiers to REP

Any transactions in scope of mandatory REP filed without the correct use of REP after the effective date of October 1, 2020, will not be accepted by Health Canada.

Questions related to this notice or general inquiries regarding REP should be sent to hc.eReview.sc@canada.ca

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