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?
- Why use the REP?
- Scope of mandatory REP
- How to use the REP
- Steps to complete, prior to filing a first regulatory transaction using the REP
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:
- Sending all regulatory transactions using a single process. This will be achieved by eliminating the use of media (CDs, DVDs, etc.) and email transmission of transactions to HPFB and instead expanding the scope of the CESG to allow regulatory transactions in non-eCTD format.
- The web-based REP templates are designed to support easier and faster data entry for sponsors with the use of drop down lists, predictive text, help text, etc.
- Since the REP files sent by sponsors are in XML format, this will facilitate the upload of the data provided into internal Health Canada systems, enhancing accuracy, consistency and reliability of the information captured.
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.
- New Drug Submission (NDS)
- New Drug Submission with flexibilities for Designated COVID-19 Drugs (NDS CV)
- Supplemental New Drug Submission (SNDS)
- Abbreviated New Drug Submission (ANDS)
- Supplemental Abbreviated New Drug Submission (SANDS)
- Notifiable Change (NC)
- Application for Drug Identification Number - Veterinary (DINV)
- Pre-Submission Meeting (MPNDS, MPANDS, MPSNDS, MPDIN, MPNC)
- Periodic Safety Information – Pharmacovigilance (PSUR-PV)
- Undefined Regulatory Activity (UDRA)
- Level III – Notice of Change
- Regulatory Cooperation Council (RCC)
- Protocol Review (PRORE)
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
- Obtain a CESG account. Refer to the Appendix G: Common Electronic Submissions Gateway (CESG) of the Guidance Document: Preparation of Regulatory Activities in non-eCTD format for detailed instructions.
- Obtain a dossier ID. The dossier ID is a mandatory field on the REP Regulatory Transaction and Product Information templates.
- For a new dossier, the dossier ID can be requested using the veterinary drug dossier ID request form.
- For existing dossiers, the assigned dossier ID may found by checking on the Drug Submission Tracking System – Industry Access (DSTS-IA). Contact the Office of Submission and Intellectual Property at email@example.com for information on setting up a DSTS-IA account.
- Specific regulatory transactions may require a REP Product Information template to be completed. Refer to the Guidance Document: The Regulatory Enrolment Process (REP): Drugs for Human/ Veterinary Use and Disinfectants for details on Product Information template requirements.
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 firstname.lastname@example.org.
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