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  6. Drug Master File (DMF) Templates
  1. Drug Master Files (DMFs)

Drug Master File (DMF) Templates

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

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.