Animal & Veterinary

Veterinary Master Files

Veterinary Master Files Lists as of October 2018
Authorization for referencing a VMF
Agents
Types of VMFs and their content
Change of ownership or company name
Closure of a VMF
Other master file guidances and information

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. VMFs at CVM are listed in the bulleted links below. CVM edited the VMF lists to remove confidential information.

Effective October 1, 2018, CVM will not accept paper 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 cvmesubmitter@fda.hhs.gov.

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). For DMF information and lists, see Drug Master Files (DMFs). Send inquiries concerning DMFs to dmfquestion@fda.hhs.gov.

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Authorization for referencing a VMF

Since all information contained in a VMF is considered proprietary, a VMF holder should send a copy of a Letter of Authorization (LOA) to third parties seeking authorization to reference a file in support of their drug applications. The LOA should include the following:

  • date of letter
  • name of VMF holder
  • VMF number
  • name of persons authorized to incorporate information in the VMF by reference
  • specific products covered by the VMF
  • sections, volumes and page numbers to be referenced
  • statement of commitment that the VMF is current and that the holder will abide with the statements made in it
  • signature of the authorizing official/agent
  • typed name and title of the official authorizing reference to the file.

The VMF holder should keep an updated list of authorized users in the master file. It is not necessary to reissue LOAs if there are no changes in the holder, authorized party, subject of the VMF or items referenced if this list is maintained in the VMF.

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Agents

There is no requirement for an agent for any VMF, foreign or domestic. An agent for a VMF is not the same as an agent for FDA’s Drug Listing and Registration System. (DRLS), which is required. Agents or contact persons for a VMF are not required to be located in the United States, although this is recommended.

Types of VMFs and their content

Type II:
Type II VMFs include manufacturing information used to support the production of the drug substance intermediates, bulk drug substance, medicated articles, medicated feeds, or finished dosage forms.

Type III:
Type III VMFs include information to support packaging materials (i.e., vials, bottles, stoppers, syringes).

Type IV:
Type IV VMFs include information to support excipients, colorants, flavors, essences, or the materials used in their preparation.

Type V:
Type V VMFs include information to support the manufacturing site, facilities, personnel, operating procedures, and sterilization process validation for the production of sterile dosage forms and sterile bulk drugs.

Type VI:
Type VI VMFs include information about free-choice medicated feeds and medicated feed assay methods.

We no longer accept Type I VMFs, and do not list them. We accept Type VI VMFs but they are not listed. Holders may seek exclusion of their VMFs from the lists upon request. Withdrawn and closed files are not included in the lists below. A VMF is "active" if the file has been updated on an annual basis. A VMF’s status is “inactive” on the lists if the VMF has not been updated in the past five years.

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Change of ownership or company name:

When a VMF holder changes its name, whether through sale of the company or change in the company’s name, the original VMF holder should notify CVM within 30 days. A change in the name of a company for registration purposes will not change the VMF holder name. When transferring a VMF from one company to another, the original holder should submit:

  • an administrative amendment stating that they are transferring the VMF to the new holder
  • contact name and address for receipt of correspondence from FDA for new holder
  • effective date of transfer
  • a statement that all rights to the files have been transferred to the new holder
  • a list of all third parties authorized to reference the file
  • a statement that a copy of the notification letter was provided to the new holder
  • signature of the responsible transferring official
  • typewritten name and title of the signer.

The new holder should then submit an administrative amendment stating that they are accepting the VMF from the former holder. CVM will not provide an acknowledgment notification for transfers of ownership or changes in holder name.

Closure of a VMF

A request to close a VMF should be submitted as a general correspondence (G submission) to the file. All authorized parties should be notified that the file will be closed before submitting. All holder obligations should be fulfilled before the VMF is closed.

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Other master file guidances and information

The following FDA Guidances for Industry may be useful for submitting and updating Type II VMFs:

GFI 5 Drug Stability Guidelines
GFI 57 Preparation and Submission of Veterinary Master Files
GFI 126 BACPAC I: Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation
GFI 169 Drug Substance Chemistry, Manufacturing, and Controls Information
GFI 216 Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use
GFI 234 Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section Of Animal Drug Applications

CVM has access to and can review DMFs in support of animal drug applications. These FDA Guidances for Industry contain general information about DMFs that may also apply to VMFs:

Drug Master Files: Guidelines
Drug Master Files for Bulk Antibiotic Drug Substances

Veterinary Master Files Lists

Please e-mail any errors found in the lists to VMSTFILE@cvm.fda.gov. Note that this e-mail address is only for communication about VMFs. Send any e-mail inquiries concerning CVM, its activities and website to AskCVM@fda.hhs.gov.

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Page Last Updated: 10/22/2018
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