Type III drug master files

The responsibility for providing information about packaging components rests foremost with the applicant of an NDA, ANDA, or BLA, or with the sponsor of an IND. This information may be provided to the applicant by the manufacturer of a packaging component or material of construction and may be included directly in the application. Any information that a manufacturer does not wish to share with the applicant or sponsor (i.e., because it is considered proprietary) may be placed in a Type III DMF and incorporated into the application by a letter from the manufacturer to the applicant that authorizes reference to the DMF. The letter of authorization should specify the firm to whom authorization is granted, the component or material of construction being described, and where the information or data is located in the file by page number or date of submission. This last item is especially important for files that contain information on multiple components or have several volumes. Information in a Type III DMF is not restricted to data of a proprietary nature. DMF holders may include in their files as much or as little information as they choose. In addition, a manufacturer of a packaging component is not required to maintain a Type III DMF. Without a DMF, there is no procedure for the FDA to review proprietary information except by submission to the application. 

The FDA ordinarily reviews a DMF only in connection with an application (IND, NDA, ANDA, or BLA). If the combined information from the application and the DMF is not adequate to support approval of the application or safety for the IND, then the agency may request additional information from the applicant or the DMF holder, as appropriate. 

In the event of a change in the DMF, the holder of a DMF must notify the holder of each application supported by the DMF (21 CFR 314.420(c)). Notice should be provided well before the change is implemented to allow the applicant or sponsor enough time to file a supplement or an amendment to the affected application. 

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