Change of Ownership or Company Name

Aug. 23, 2022

When a VMF holder changes its name, whether through sale of the company or change in the company’s name, the original VMF holder should notify CVM within 30 days. A change in the name of a company for registration purposes will not change the VMF holder name. When transferring a VMF from one company to another, the original holder should submit:

An administrative amendment stating that they are transferring the VMF to the new holder

Contact name and address for receipt of correspondence from FDA for new holder

Effective date of transfer

A statement that all rights to the files have been transferred to the new holder

A list of all third parties authorized to reference the file

A statement that a copy of the notification letter was provided to the new holder

Signature of the responsible transferring official

Typewritten name and title of the signer.

The new holder should then submit an administrative amendment stating that they are accepting the VMF from the former holder. A statement of commitment signed by the new VMF holder should be included in name change and acceptance notifications stating that the VMF is current and that the holder will comply with the statements made in the VMF. CVM will not provide an acknowledgment notification for transfers of ownership or changes in holder name.

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