Notice: Mandatory use of the regulatory enrolment process (REP) for veterinary drugs as of October 1, 2022

June 13, 2022
Our file number: 22-107135-311

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 has been mandatory for human drugs and disinfectants since 2020.

Use of the REP will be mandatory as of October 1, 2022, for veterinary drugs.

On this page

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 included in regulatory transactions and are sent to HPFB via the Common Electronic Submissions Gateway (CESG).

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 regulatory activities for Veterinary drugs pursuant to Part C - Division 1 and Division 8 of the Food and Drug Regulations.

Please note: Emergency Drug Release (EDR), Experimental Studies Certificate (ESC), Investigational New Drug (IND) are out of scope of REP.

How to use the REP

Although the use of REP will be mandatory beginning on October 1, 2022, 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 (REP): Drugs for Human/Veterinary Use and Disinfectants, as early as possible. Detailed information regarding the REP is available on the REP information page.

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

Any transactions in scope of mandatory REP filed without the correct use of REP after the effective date of October 1, 2022, will not be accepted by Health Canada.
Questions related to this notice or general inquiries regarding REP should be sent to vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca.

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: