Notice: Update to the Guidance Document: Master Files (MFs) – Procedures and Administrative Requirements Effective January 1, 2022

January 1, 2022
Our file number: 21-122046-692

Health Canada is pleased to announce an update to the Guidance Document: Master Files (MFs) – Procedures and Administrative Requirements. This latest update to the Guidance Document introduces changes for MFs, as well as, increases clarity regarding the filing requirements for MFs.

The changes are summarized as follows:

• Introduction of the new Type V MF to allow MF Holders to file confidential business information for facilities and equipment related information directly to Health Canada, to be referenced in support of an Applicant's drug submission (including DIN Applications) or Clinical Trial Application (CTA). Refer to Section 1.3 Scope and Application of the Guidance Document for the description of information that can be filed under the Type V MF.
• A change to the fee payment processes related to MFs. Payment for MF related transactions will no longer be accepted at the time of filing. Instead, an invoice will be sent to the billing contact after the filing has been deemed administratively complete. Payment will be due 30 days from the issuance of the invoice. Refer to the Notice of Change for How to Pay Fees for Master Files dated November 26, 2021.

The updated Guidance Document: Master Files (MFs) – Procedures and Administrative Requirements will be effective as of January 1, 2022.

Questions or comments regarding this Notice or the Guidance Document: Master Files (MFs) – Procedures and Administrative Requirements can be sent to dmf.enquiries-fmm@hc-sc.gc.ca.

Questions of comments regarding the Notice of Change for How to Pay Fees for Master Files dated November 26, 2021 can be sent to cost.recovery@hc-sc.gc.ca.

Thank you,

Master File Administration Unit
Office of Submissions and Intellectual Property
Resource Management and Operations Directorate
Health Products and Food Branch

Health Canada