Aug. 23, 2022
We first recommend that you register with our Electronic Submission System and download our eSubmitter software as detailed here: CVM Guidance for Industry #108 Registering with CVM’s Electronic Submission System if you do not have an account. To establish a new VMF, use eSubmitter and attach a letter requesting establishment of a VMF as part of the initial submission through eSubmitter. A response e-mail should arrive within a few minutes that signals successful transmission through eSubmitter and contains the new VMF number. CVM recommends that one VMF per facility per drug substance be opened. If a VMF holder manufactures a drug substance at another site, even with similar processes, each facility should have its own VMF.
VMFs are not subject to the same user fees as Drug Master Files (DMFs) that are used to support human drugs. CVM does not charge a fee to establish, amend, or reference a VMF under its current user fee agreements. VMFs do not undergo completeness assessments before review as do DMFs submitted to FDA’s Center for Drug Evaluation and Research (CDER). CVM has access to and can review DMFs in support of animal drug applications. If a master file is referenced in support of both animal and human drugs, then only a single DMF (and no VMF) should be maintained. For DMF information and lists, see Drug Master Files (DMFs). Send inquiries concerning DMFs to [email protected]
Source from FDA
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