Veterinary drugs master file updates and fees consultation: Notice
June 02, 2023
Our file number: 23-103954-307
On this page
Background
The Health Products and Food Branch (HPFB) will be updating master file (MF) registration as a part of the continuing effort to implement a common intake approach for all drug product lines, including veterinary drugs. MFs holders and applicants using MFs to support veterinary drug submissions will need to submit MF transactions via the Common Electronic Submission Gateway (CESG) using an application form in Extensible Markup Language (XML) format. This update is consistent with the transition of human drug MFs application form to a web-based form effective June 26, 2023.
Additionally, HPFB is consulting on a proposal to implement fees for MF for veterinary drugs, to align with the existing MF fee structure for human drugs. Comments on the MF fees proposal will close on August 12, 2023.
Both changes for veterinary drugs are proposed to go into effect January 2, 2024.
Important information
Using a web-based form to encode the MF's content:
- allows a single process for submitting information
- removes file size limitations imposed by other communication methods, such as email
- enhances accuracy, consistency and reliability of the information captured in Heath Canada systems
This form will have to be included with every eCTD and non-eCTD transaction that is sent via the CESG.
We will make a web-based template available. It will generate an XML file upon completion.
For more information on the required MF format and CESG refer to the:
- Guidance document: Preparation of regulatory activities in non-eCTD format
- Guidance document: Preparation of regulatory activities in eCTD format (available upon request via email at no-reply.ereview.non-reponse@hc-sc.gc.ca)
We will continue to keep confidential business information confidential in accordance with applicable law, including the Access to Information Act and the Food and Drugs Act.
Updates to process
This transition will align the MF process for human and veterinary drugs. As such, we will update the existing master file guidance for human drugs to expand the scope to include veterinary drugs. We will publish the updated guidance in advance of any change.
Fees consultation
MF registration is a non-regulatory activity service provided by HPFB. It offers a mechanism for giving confidential business information to Health Canada that isn't available to:
- the applicant of a drug submission
- the manufacturer of the dosage form
To recover the costs associated with registering and maintaining MFs, we will charge existing MF fees for veterinary MF-related activities. There are different fees for new MF registrations, MF updates and MF letters of access.
The fees, effective January 2, 2024, are:
| Fee | 2023-24 fee amount (Canadian $) |
|---|---|
| New Master Files (file registration) | 1,351 |
| Drug Master Files – letter of access | 192 |
| Drug Master Files - Update | 587 |
We increase these fees by 2% annually on April 1st. We will publish the adjusted fees in the annual Health Canada fees report and on the Health Canada website.
We will maintain current service standards (30 calendar days) for these MFs.
We won't charge existing MFs the file registration fee, however we will charge all letters of access or updates the applicable fees as of January 2, 2024.
The fees consultation will be open for 70 days and will close on August 12, 2023. You can submit comments to CRO-BRC@hc-sc.gc.ca.
For more information on the current MF procedures and administrative requirements for veterinary drugs, please consult the guidance document.
Contact us
Contact Veterinary Drugs Directorate with questions related to this notice or general inquiries regarding master file registration process.
Page details
- Date modified: