FDA Veterinary Master Files

Aug. 23, 2022

A Veterinary Master File (VMF) is a submission to the Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) that provides confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of veterinary drugs and drug substances.

CVM will no longer accept paper VMF submissions. VMFs should be submitted electronically using CVM’s eSubmitter tool. For information about submitting electronically to CVM, see CVM’s Electronic Submissions page. If you have any questions regarding electronic submissions, email CVM’s Electronic Submissions Support Team at [email protected].

Types II-V Veterinary Master Files Lists
Types of VMFs and Their Content
Opening a New VMF
Authorization for Referencing a VMF
Change of Ownership or Company Name

Closure of a VMF

A request to close a VMF should be submitted as a general correspondence (G submission) to the file. The request should include a statement that all authorized parties have been notified of the closure. All holder obligations, including completion of any stability commitments, should be fulfilled before the VMF is closed.

Master File and Drug Substance Guidances

FDA and International Guidances for Industry (GFIs) that may be useful for submitting and updating master files may be found at Chemistry Manufacturing and Controls (CMC) Guidances for Industry (GFIs).

Inspection Classification Database Search

For information regarding FDA inspections of regulated facilities, please read about the FDA Inspection Classification Database and search the database.

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