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:

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

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