submit an electronic resubmission to a paper DMF unless they resubmit the entire DMF in electronic format. Companies may convert an existing DMF in paper format to electronic format (ECTD only). See “Conversion to CTD” above. The ECTD format provides the backbone for the submission, and a guide as to where to place information. Companies need not submit all modules, nor submit all sections within a module. However, the FDA requires Module 1 for all eCTD submissions, as it contains the administrative information that identifies the DMF. Electronic signatures are accepted for electronic DMFs. Letters of authorization (Category 2) The company must submit two copies of all letters of authorization (LOAs) to the DMF. The DMF holder must then send a copy of the LOA to the authorized party (company or individual authorized to incorporate the DMF by reference). Failure to submit the LOA to the DMF may delay review of the DMF. LOAs must specify the name of the specific item referenced, and the date of the submission of information about that item. The LOA must not be called a letter of access. An LOA is required, even if the DMF holder is the same company as the authorized party. Companies must not submit LOAs with original paper DMFs, because the LOA must contain the DMF number. Therefore, DMF holders must wait to submit an LOA until they receive an acknowledgment letter with the DMF number. An LOA can be submitted with the original DMF if the DMF has received a pre-assigned number. It is not necessary to reissue LOAs if there have been no changes in the holder, authorized party, subject of the DMF or item referenced. If the holder or authorized party changes names, whether this represents a change in ownership or not, they should submit new LOAs to the DMF and copies sent to the authorized party. LOA Template AGENTS (Category 2) There is no regulatory requirement for an agent for any DMF, foreign or domestic. An agent for DMF purposes is not the same as an agent for the purposes of the Drug Listing and Registration System. (DRLS). Holders should not include the name of the agent for Registration purposes in the DMF. Also note that in the US, the process of “Registration” applies ONLY to “registering” an establishment with the FDA. All “Agent Appointment Letters” for DMFs MUST be sent by the holder. FDA