June 2, 2023
Our file number: 23-103954-307
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The Health Products and Food Branch (HPFB) will update the Master File (MF) registration process as part of its ongoing efforts to establish a common registration system for all types pharmaceuticals, including veterinary drugs. MF holders or applicants using a MF to support their veterinary drug submission will be required to submit MF transactions through the Common Electronic Submission Portal (CRSP) using an application form in XML format ( extensible markup language). This update aligns with the transition of the FM request form for human drugs to a web form which will take effect on June 26, 2023.
In addition, HPFB is consulting on a proposal to implement MF fees for veterinary drugs to align with the existing MF fee structure for human drugs. The comment period on the FM fee proposal will end on August 12, 2023.
The 2 changes concerning veterinary medicinal products should come into force on January 2, 2024.
Using a web form to encode FM content:
- allows the use of a single process to transmit information
- eliminates file size restrictions imposed by other communication methods, such as email
- improves the accuracy, consistency and reliability of information entered into Health Canada’s systems
This form will need to be attached to every eCTD and non-eCTD transaction sent through the EDCP.
We will provide you with a web-enabled template. An XML file will be generated once the template is completed.
To learn more about the required FM format and the PCDE:
We will continue to maintain the confidentiality of confidential business information in accordance with applicable law, including the Access to Information Act and the Food and Drugs Act.
This transition will allow a harmonization of the FM process for medicinal products for human and veterinary use. As such, we will update the guideline on master files for human medicinal products to extend the scope to veterinary medicinal products. We will post the updated version of the guideline before making any additional changes.
FM registration is a non-regulatory activity service offered by HPFB. It provides a mechanism for transmitting confidential business information to Health Canada to which the following actors do not have access:
- the applicant for a drug submission
- the manufacturer of the dosage form
To recover the costs of registering and managing FMs, we will charge a fee for existing FMs for FM-related veterinary activities. There are different fees associated with new FM registrations, FM updates and FM access letters.
The fees, which will take effect on January 2, 2024, are as follows:
|Costs||Amount of fees (Canadian $) in 2023-2024|
|New master files (registration of files)||1 351|
|Drug Master Files – Letter of Access||192|
|Drug Master Files – Update||587|
We increase these fees by 2% per year on the 1st april. We will publish the adjusted fees in Health Canada’s annual fee report and on the Department’s website.
Current service standards (30 calendar days) will be maintained for these FMs.
We will not charge case registration fees for existing FMs, but we will charge applicable fees for any letters of access or updates from January 2, 2024.
The 70-day fee consultation will end on August 12, 2023. You can send your comments to CRO-BRC@hc-sc.gc.ca.
To learn more about FM procedures and current administrative requirements for veterinary drugs, please see the guidance.
If you have any questions regarding this notice or the Master File registration process, please email the Veterinary Drugs Directorate.
E-mail : firstname.lastname@example.org
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