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Submission Unit (RPS)

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Revision as of 16:28, 19 September 2008 by Joelfinkle (talk | contribs) (RPS Submission Unit moved to Submission Unit (RPS): Alphabeticization is kind of useless if everything starts with RPS)
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RPS Submission

This is a Glossary page

R1 Working Definition

The collection of [[RPS Document|documents] provided to the regulatory authority at one time. A Filing or Correspondence between parties.

ICH Equivalent



Submission Unit - The collection of documents provided to the regulatory authority at one time.

NOTE: A submission unit is made up of one to many documents. Properly defined, the submission unit concept enables companies to create new submission units from any combination of new and previously submitted document.

NOTE: In the dynamic aspects of the model, a submission unit is one message that may have a collection of many documents. There are rules for how submission units are evaluated are described in a state diagram, and the receipt date of the submission unit "starts the clock" for the review of the contents of the submission unit.