|
Table of Contents
Master Files
Inactive VMF
Active VMF
Five Categories
|
| |
This site contains a list of Veterinary Master Files (VMFs),
which are applicable only to the chemistry, manufacturing and
controls for a finished dosage form and/or a bulk drug substance.
The list has been redacted or edited to remove confidential
information. The list contains file category (or type), number,
status (active or inactive), holders name, and chemical
name or subject.
The VMFs are classified into five
distinct categories:
Type I: |
Manufacturing Site, Facilities, Personnel,
and Operating Procedures. |
Type II: |
Manufacturing information for bulk drug
substance or intermediates used in the further 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. |
The Center for Veterinary Medicine (CVM) has eliminated the
need to submit or update a Type I VMF. The veterinary industry
was informed of CVMs intent to eliminate the Type I in
a Policy Letter dated July 26, 1995. Consequently,
all Type I VMFs were classified as "inactive."
The listing of the master files is available in four different
reports:
-
Data sorted by VMF #, then by VMF Holder
-
Data sorted by File Type, then by VMF Holder
-
Data sorted by VMF Holder, then by File Type
-
Data sorted by chemical/subject, then File Type.
A VMF is inactive if:
-
The holder requested that the VMF be inactivated or withdrawn.
-
The VMF has not been updated since 1994.
A VMF is classified as "active"
if the file has been updated on an annual basis.
Any errors found in the listing should be emailed to VMSTFILE@cvm.fda.gov
. Please note that this e-mail address is only for correcting
the VMF listing. Any e-mail inquiries concerning CVM, its activities
and website, should be submitted to CVMHomeP@cvm.fda.gov.
Written inquiries should go to:
William G. Marnane
Director
Division of Manufacturing Technologies
Office of New Animal Drug Evaluation
Center for Veterinary Medicine
7500 Standish Place
Rockville, MD 20855
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 in "Master Files, Guidance for
Industry for the Preparation and Submission of Veterinary Master
Files"
[pdf] [html]
Adobe
Acrobat Reader is needed to review PDF files.
Web page updated by swd,
Octobert 5, 2004, 11:56 AM ET
|
|