Product (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

TBD. Definition may be coming from other areas, e.g. HL7 Common Product Model. However, it must meet RPS2 needs, such as general administrative references ("what product is this message about?"), labeling, overall life-cycle, etc. Generally agreed that it should also be as simple/small as possible to accomplish this. There is a need to have multiple Products per Submission (and therefore [Submission Unit (RPS)|Submission Units]). Not in RPS1. See also Regulated Product.

ICH Equivalent

Drug-Product associated with a Dosage Form and Manufacturer(s)

BRIDG Term

Product

A thing produced by or resulting from a process.

For example, a drug or device.

For example, the FDA list of regulated products: animal and human drugs; therapeutic biologics; allergenics; cell, tissue and gene therapy products; blood components; blood derivative products; devices; and animal (pets and livestock) and human food/feed (medicated and unmedicated); cosmetics; pet treats; and dietary supplements.

Additional Regional Definitions and Synonyms