Notice: Regulatory Enrolment Process (REP) Pilot for Veterinary Drugs
July 2, 2019
Our file number: 19-105829-323
Health Canada is pleased to request sponsor participation in the Regulatory Enrolment Process (REP) pilot for veterinary drug regulatory activities.
What is REP?
The REP will help the veterinary drug industry file their drug submissions to Health Canada electronically. By using the Common Electronic Submission Gateway (CESG), sponsors will be able to send 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 are currently collected using submission application forms. Once fully implemented, the REP templates will replace the current veterinary drug submission filing process, including 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 built-in logic, which help to increase the accuracy of information provided in the templates to support the regulatory review process.
Health Canada has been piloting the REP with pharmaceutical and biologic human drug regulatory activities since February 2017, and Medical Devices since June 2019. Health Canada intends to launch a pilot project for veterinary drug regulatory activities in November, 2019.
REP Pilot for veterinary drugs
- Pilot start date: November 1, 2019.
- Scope: The following veterinary drug regulatory activities:
- New Drug Submission (NDS)
- Supplemental New Drug Submission (SNDS)
- Abbreviated New Drug Submission (ANDS)
- Supplemental Abbreviated New Drug Submission (SANDS)
- Notifiable Change (NC)
- Drug Identification Number (DIN) Application
1. How to request to participate in the REP Pilot
Sponsors may express their interest by:
- Sending an email to request to participate to hc.eReview.email@example.com, with the subject heading “REP Pilot veterinary drugs”.
- Providing the following information with the email request:
- Sponsor name
- Contact information
- Number of new and/or existing dossier(s) planned
- Number of regulatory activities planned
We encourage sponsors to submit their requests for participation as soon as possible.
All requests will be assessed based on the requirements below. Further instructions on how to use the REP will be provided to all accepted participants.
2. Sponsors need to commit to the following requirements, if selected, to participate in the REP Pilot:
- Participants need to have a CESG account, and if not, must obtain one as soon as possible.
- All REP XML files must be sent to Health Canada via the CESG, as no other method of transmission will be accepted.
- Once a participant uses the REP for a dossier (drug product), they need to continue to use the REP for all subsequent regulatory activities and transactions for that dossier.
Note that Health Canada may limit the number of dossiers enrolled per participant.
Throughout the pilot, Health Canada will be seeking feedback from participants on the new forms and processes, including requesting the completion of a survey. Participant feedback will inform a broader roll-out of REP to stakeholders.
For further information on the REP Pilot, email hc.eReview.firstname.lastname@example.org.
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