Animal & Veterinary

Veterinary Master Files

Veterinary Master Files as of July 2014

Veterinary Master Files (VMFs) are submissions to CVM that provide confidential information about veterinary drugs and drug substances. Third parties should get authorization from a VMF holder to reference a file in support of their drug applications. CVM edited the VMF lists below to remove confidential information. Holders may seek exclusion of their VMFs from the lists upon request. We classify VMFs in five types:

Type I:  Manufacturing site, facilities, personnel, and operating procedures.

Type II:  Manufacturing information for bulk drug substance or intermediates used in the manufacture of the bulk drug substance, medicated articles, medicated feeds, or manufacturing information for finished dosage forms.

Type III:  Packaging materials.

Type IV:  Excipient, color, flavor, essence, or material used in their preparation.

Type V:  Manufacturing site, facilities, personnel, operating procedures, and sterilization process validation to support the manufacture of sterile dosage forms and sterile bulk drugs.

We no longer accept Type I VMFs, and do not list them here. Withdrawn and closed files are not listed. A VMF is "active" if the file has been updated on an annual basis. A VMF’s status is “inactive” on the lists if:

  1. The holder requested that the VMF be inactivated or withdrawn.
  2. The VMF has not been updated in the past five years.

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

Additional information regarding the types of master files, submission format, information needed, procedures governing the review of the master files, and obligations of the master file holder can be found at Guidance for Industry for the Preparation and Submission of Veterinary Master Files.

  

Page Last Updated: 07/07/2014
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