Notice of Intent for the Veterinary Drugs Regulatory Enrolment Process Pilot Project

November 28, 2018
Our file number: 18-117078-773

The purpose of this Notice of Intent is to inform stakeholders that Health Canada will be launching a Regulatory Enrolment Process (REP) pilot project for veterinary drug regulatory activities (submissions) in spring 2019.

What is REP?

The REP will help the veterinary drug industry send information related to their company in advance of the regulatory review process to Health Canada electronically. Using the Common Electronic Submission Gateway (CESG), sponsors will be able to share this information in a secure manner, with reduced transmission times and cost. The CESG has been in operation at Health Canada since February 2014 for a subset of regulatory activities. Please refer to the Frequently Asked Questions - Common Electronic Submission Gateway (CESG FAQ) for details.

REP will facilitate the filing and processing of information related to companies, dossiers, regulatory activities and regulatory transactions, which is currently collected using submission application forms. Once fully implemented, the REP templates will replace existing Health Canada forms such as the HC 3011 form and Fee forms. The expansion of the REP to veterinary drugs is part of a broader move towards a common submission intake across product lines.

REP consists of a set of web-based templates that capture sponsor provided information in a structured XML (Extensible Markup Language) format. This format uses pick lists and business rules, which help to increase the accuracy of information provided in the templates to support the regulatory review process.

REP pilots

Health Canada has been piloting the REP with pharmaceutical and biologic human drug regulatory activities since February 2017. Health Canada intends to a launch pilot project for the Veterinary Drug regulatory activities in spring of 2019.

Prior to initiating the REP pilot projects, Health Canada will:

• Share further information with interested stakeholders about the REP process.
• Solicit participation from the veterinary drug industry.
• Work with participating sponsors to create a CESG account.

Note that regulatory transactions for veterinary drugs will continue to be accepted in non-eCTD format only.

Please send comments regarding this advanced notice to hc.ereview.sc@canada.ca.