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File (RPS)

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This is a Glossary page

This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized

R1 Working Definition

A single electronic file included in a Dossier. A file may constitute an entire Document, or be considered a part of a Document.

In RPS R1, each File is an element of the Application (Dossier), and is referred to by the Context of Use.

ICH Equivalent



This section is currently incomplete

Additional Regional Definitions and Synonyms