Change of DMF (Drug Master File)

What are all the procedure to follow while changing the Drug Master File (DMF) to the new applicant.

Say ?A? is the holder of the DMF, ?A? needs to change the DMF to the name of the ?B?.

What are all the steps / procedure to follow with the regulatory agencies and customers?

Is there any check list for this?

raghu_1968 said:

What are all the procedure to follow while changing the Drug Master File (DMF) to the new applicant.

Say ?A? is the holder of the DMF, ?A? needs to change the DMF to the name of the ?B?.

What are all the steps / procedure to follow with the regulatory agencies and customers?

Is there any check list for this?

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As per http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122886.htm

VII. E. Transfer of Ownership
To transfer ownership of a DMF to another party, the holder should so notify FDA and authorized persons in writing. The letter should include the following:

Name of transferee
Address of transferee
Name of responsible official of transferee
Effective date of transfer
Signature of the transferring official
Typewritten name and title of the transferring official.
The new holder should submit a letter of acceptance of the transfer and an update of the information contained in the DMF, where appropriate. Any change relating to the new ownership (e.g., plant location and methods) should be included.

Thanks.

What we have to do for Europe? IS there any guidance for that?