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New Holder Acceptance Letter (Holder's Official STATIONERY)

By Barry Peterson,2014-10-03 10:03
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New Holder Acceptance Letter (Holder's Official STATIONERY)

HOLDER NAME CHANGE Letter

No Cover (Transmittal) Letter necessary

Notes are in bold font. Information to be filled in is in italics

    Date: Enter the date of the Submission

DMF#: Enter the DMF number

Holder: Enter the Original Name of Holder

    Subject: Enter the Subject of the DMF as it appears on the DMF Web site. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/Drug

    MasterFilesDMFs/default.htm

Submission Information: General Information/Administrative/Change in Holder: Internal Name

    Change

New Holder Name: Enter the New Name of Holder

Include the following:

    Information regarding the change in Name of holder

Sincerely,

    Signature of Responsible Official Enter

    Name of Responsible Official Responsible Official’s Title

    Responsible Official’s Company Name i.e. Holder Responsible Official’s Telephone number

    Responsible Official’s Fax number

    Responsible Official’s e-mail address

Notes

    This letter must come from the Holder. Letters from the U.S. Agent are not accepted for Holder Name Change Letters.

    Use this letter ONLY when there is an internal name change. Do not use when a DMF is transferred from one company to another.

The letter must be on the letterhead reflecting the name change.

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