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1.12-Letters of Reference For Master Files

The document outlines the requirement for a letter of reference from a Master File owner, which grants access to the information within the master file and specifies the scope of access. This letter is conditionally required for Class 3 new and amendment submissions when a Master File is referenced. It is part of the IMDRF common content guidelines.

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11 views1 page

1.12-Letters of Reference For Master Files

The document outlines the requirement for a letter of reference from a Master File owner, which grants access to the information within the master file and specifies the scope of access. This letter is conditionally required for Class 3 new and amendment submissions when a Master File is referenced. It is part of the IMDRF common content guidelines.

Uploaded by

montrealfolo
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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1.

12 - Letters of Reference for Master Files


IMDRF COMMON CONTENT
Letter from any Master File owner granting access to the information in the master file. The letter
should specify the scope of access granted.

HC CLASSIFICATION
Class 3 New and Amendment: Conditionally Required - When a Master File is referenced

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