Drug Master File (DMF) Templates

The following templates recommend elements to include in certain DMF submissions:

• Cover Letter: Original Submissions
• Cover Letter: Subsequent Submissions
• Letter of Authorization
• Annual Report Template
• Agent Appointment Letter

• DMF Holder Name Change Letter
• DMF Holder Transfer Letter
• New Holder Acceptance Letter
• Request for Closure Letter
• Withdrawal of LOA Letter

In these letters, list the submission type and, if applicable, the amendment type as laid out below:

DMF Submission and Amendment Types

Submission Type	Amendment Type
Original (New)
Administrative Amendment	Change of Agent/Address/Contact Person Change of Holder/Address/Contact Person Change of DMF Subject (Title) Change of DMF Type Agent Appointment
Annual Report
Letter of Authorization
Withdrawal of Letter of Authorization
Meeting	Meeting Package Meeting Request
Quality Amendment	Controls Information Facility Information Formulation Information Manufacture Information Microbiology Information New Item* Packaging Information Stability Information
Response to Administrative Filing Issue
Response to Deficiency, Complete Response, Information Request or Additional Comments Letter
REMS—Risk Evaluation and Mitigation Strategy	REMS Final REMS Assessment REM Assessment Methodology REMS Revision REMS Modification—Due to Safety Labeling Changes REMS Modification—Major REMS Modification—Minor REMS Proposal—Standard REMS Correspondence
Other	Other

_{* For Type III and Type IV DMFs, new item represents a new item in the DMF, such as a rubber stopper, cap, and so forth.}