DMF File Submission Guideline

The primary packaging material is defined as the material that that may or may not be in direct contact with the dosage form. Primary packaging may comprise any single part of a container closure system including containers, container liners, closures, closure liners, stopper oversells, etc.

A secondary packaging material is a packaging component that is not in direct contact with the dosage form. Current good manufacturing practice (cGMP) requirements for the control of drug product containers & closures are defined in 21 CFR Part 210 & 211.

DMF File Preparation & Submission:

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA). That may be used to provide classified detailed information about processes, facilities, or unit used in the manufacturing, packaging, processing, and storing of one or more human drugs.

Beginning on May 5, 2018, new DMFs, as well as all documents submitted to existing DMFs, must be submitted using the Electronic Common Technical Document (eCTD). DMF submissions that are not submitted in eCTD format after this date will be rejected.

DMF is a submission of information to the FDA by the holder to support an Investigational New Drug Application (IND) or a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA).

TYPES OF DMFs

  • The Types of DMFs are:
  • DMFs Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable).
  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product.
  • Type III Packaging Material.

There appears to be some confusion regarding when a Type III DMF (packaging material) should be submitted. It is not required that packaging information is submitted to the FDA in a DMF. This information may be provided to the applicant by the manufacturer of a packaging component or material of construction. That may be included directly in the application. Any information that a manufacturer does not wish to share with the applicant or sponsor may be placed in a Type III DMF and incorporated into the application by a letter from the manufacturer to the applicant which authorizes reference to the DMF.

  • Type IV x Colorant, Flavor, Essence, or Material Used in Their Preparation.
  • Type V FDA Accepted Related Information.