Description
This document is intended to provide guidance for the preparation and submission of master files to the Center for Veterinary Medicine. This document discusses the types of master files, information needed, submission format, procedures governing the review of master files, and obligations of the master file holder.
Scope & Applicability
Product Classes
6Products manufactured by establishments in the reporting program
Type III: Packaging Material
formaldehyde as a drug product impurity
Type A Medicated Article intended for use in manufacture of other medicated feeds.
Guidance on the use of tracers in animal food, Type A medicated articles, and medicated feeds.
manufacturing information for medicated articles should be retained in Type II VMFs
Stakeholders
6The entity responsible for the submission and authorization of the master file; The entity responsible for maintaining and authorizing access to the VMF
entity submitting marketing applications
Holders of approved applications or master files
Entity responsible for submitting applications under section 524B
The VMF holder should submit the appropriate labeling components.
Representative of a foreign owner who serves as the FSVP importer; Person in the US acting as a communications link or FSVP representative.; Designated representative for foreign owners; designated representative for foreign owners
Regulatory Context
Attributes
1All information contained in a master file is considered confidential
Related CFR Sections (6)
- 21CFR10.90§ 10.90 Food and Drug Administration regulations, recommendations, and agreements.
(a) Regulations. FDA regulations are issued in the Federal Register under § 10.40 or § 10.50 and codified in the Code of Federal Regulations. Regulations may contain provisions that will be enforced as legal requirements, or which are intended only as guidance documents and recommendations, or both.Read full regulation →
- 21CFR25.31§ 25.31 Human drugs and biologics.
The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:Read full regulation →
- 21CFR514.1§ 514.1 Applications.
(a) Applications to be filed under section 512(b) of the act shall be submitted in the form and contain the information described in paragraph (b) of this section, as appropriate to support the particular submission. If any part of the application is in a foreign language, an accurate and complete ERead full regulation →
- 21CFR514.11§ 514.11 Confidentiality of data and information in a new animal drug application file.
(a) For purposes of this section the NADA file includes all data and information submitted with or incorporated by reference in the NADA, INAD's incorporated into the NADA, supplemental NADA's, reports under §§ 514.80 and 510.301 of this chapter , master files, and other related submissions. The avaRead full regulation →
- 21CFR314.420§ 314.420 Drug master files.
(a) A drug master file is a submission of information to the Food and Drug Administration by a person (the drug master file holder) who intends it to be used for one of the following purposes: To permit the holder to incorporate the information by reference when the holder submits an investigationalRead full regulation →
- 21CFR558.3§ 558.3 Definitions and general considerations applicable to this part.
(a) Regulations in this part provide for approved uses of drugs and combinations of drugs in animal feeds. Approved combinations of such drugs are specifically identified or incorporated by cross-reference. Unless specifically provided for by the regulations, a combination of two or more drugs is noRead full regulation →
See Also (8)
- Topical Dermatologic Corticosteroids: in Vivo Bioequivalence (Status: Final)
- Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro (Status: Final)
- SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (Status: Final)
- Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use (Status: Final)
- Review of FDA's Implementation of the Drug Export Amendments of 1986 (Status: Final)
- CVM GFI #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs (Status: Final)
- CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species (Status: Final)
- Use of a Drug Master File for Shared System REMS Submissions Guidance for Industry (Status: Draft)