What should you know about DMF annual report

In the  industry there  is  lot of confusion  about  content and format of   DMF  annual report

Important  –  DMF annual reports are  NOT used for   reporting changes in the drug master file. Amendments  are used for reporting changes in the DMF.

Contents of DMF annual report.

1.Cover letter – Annual report should contain the formal cover letter stating the submission contains annual report , referring the DMF number.

2.Tabular summary of amendments since last annual report.- We recommend providing tabular summary with date of amendments and brief information about the purpose of amendments. However, if there are no amendments submitted since last annual report, a statement “no amendments are submitted since last annual report” can be added in the annual report.

3.List of parties to whom LOA (Letter of Authorization ) is issued till date. Incase of authorization are not issued to any companies such statement should be added. In the each DMF annual report complete list if all the authorized parties must be added.

4. List of parties whose authorization letter is withdrawn (if applicable)

When the DMF annual report should be submitted  ?

Generally,  annual reports should  be submitted on the  anniversary (after one year ) of  original DMF filing.

Failure  to submit annual report in timely manner   may result in the DMF deactivation, since  annual reporting filing is mandatory requirement  to maintain  “Active” status of your DMF.

FDAbasics can offers services for annual report compilation and submission in the eCTD format including submission to FDA through our ESG gateway.

If you have any questions regarding DMF  filing , please contact us.