The Main Objective of the EDMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a Marketing Authorisation grant. DMF LISTS IMPORTANT NOTE The current list contains DMFs RECEIVED by March 31, 2012. However the submitted date is listed for each DMF. The list of DMFs is current as of March 31, 2012, through DMF 25923. Changes to the DMF activity status, DMF type, holder name, and subject made since the last update of January 11, 2012 are included. The list is available in Microsoft Excel and in ASCII (tab-delimited). The current lists are posted (1Q2012) as well as the lists from the last quarter (4Q2011) to permit users to compare lists for updates and changes. TYPES OF DMFs The types of DMFs are: Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable) Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product Type III Packaging Material Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation Type V FDA Accepted Reference Information STATUS OF DMFS “A” = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date. “I” = Inactive “N” = Not an assigned number “P” = DMF Pending Filing Review The status conveys no information about whether DMF has been reviewed for technical content. INACTIVE STATUS OF DMFs There are three reasons to list a DMF as inactive: The holder requested that the DMF be closed (or retired, closed, inactivated, or withdrawn) by submitting a closure request. The FDA closed the DMF because the holder did not respond to an overdue notification letter within 90 days by updating the DMF. The DMF was overdue for update. The FDA considers DMFs submitted before March 31 overdue for update when the company has submitted no annual reports since that date. The FDA considers only an annual report sufficient to prevent them sending an overdue notice letter (ONL). The status Inactive in the list does not distinguish among the reasons listed above. DMFs must be current at the time of review. According to FDA regulations regarding DMFs (21 CFR 314.420(c)): “Any addition, change, or deletion of information in a drug master file (except the list required under paragraph (d) of this section) is required to be submitted in two copies and to describe