Authorization for Referencing a VMF

Aug. 23, 2022

CVM will not review a VMF until the VMF holders submits a letter of authorization (LOA) to the VMF regarding a specific application or another VMF. The LOA permits CVM to review the VMF and permits the authorized party (the company or individual who submits an application or another VMF) to incorporate information into an application or another VMF by reference. The VMF holder should send a copy of the LOA to an authorized party. The authorized party should include a copy of the LOA in its application or VMF. An LOA does not give an authorized party permission to view or access a VMF. The VMF holder should submit each LOA to the VMF. The LOA should include the following:

Date of letter

Name of VMF holder

VMF number

Name of persons authorized to incorporate information in the VMF by reference

Specific products covered by the VMF

Sections, volumes and page numbers to be referenced

Statement of commitment that the VMF is current and that the holder will abide with the statements made in it

Signature of the authorizing official/agent

Typed name and title of the official authorizing reference to the file.

The VMF holder should keep an updated list of authorized users in the master file. It is not necessary to reissue LOAs if there are no changes in the holder, authorized party, subject of the VMF or items referenced if this list is maintained in the VMF. If the VMF holder or authorized party changes its name, the VMF holder should submit a new LOA. LOAs should include the VMF number and therefore should not be provided in the first submission to the VMF.

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