1. Company participation Wholesaler/ Distributor Milestone deliverables
GSMP Messaging for Verification of Pharmaceutical Saleable Returns Mission Specific Work Group (MSWG)
Update as of:
01 January 2019
WR #
Due Date
December 2018
Step #
Complete & Closed
OGSM No
Chairs
Allison Sheldon – Pfizer
Elizabeth Waldorf – TraceLink
Jeff Denton – AmerisourceBergen Corporation
Project description
This group will develop a messaging standard for verification of Pharmaceutical saleable returns. Initially designed to meet the requirements of the US FDA DSCSA, the completed standard could potentially also be leveraged for other regulatory jurisdictions requiring verification of serialized products.
Deliverable /Objective
Specification of a streamlined, synchronous GS1 messaging standard encompassing a Request format and Response format for Verification of a given Pharmaceutical trade item identified by GTIN, Serial Number, Lot and Expiry.
Stakeholders
Company participation
LT Sponsor
Marianne Timmons
SDL
Greg Rowe
SME
Mark Harrison
IE Liaison
Craig Alan Repac
AG liaison
Elizabeth Waldorf
Project approved
21-May-18
Manufacturer
Wholesaler/ Distributor
SPs
Other
Actual roster 5 3 11
Roster participation required 2
Minimum votes required (12 Total)
Milestone deliverables
Milestones
Deliver date/status
Requirements complete
12 July
Requirements Community Review
27 July
Requirements eBallot approved
16 August
Application Standard complete
25 October
Application Standard Community Review
16 November
Application Standard IP Review
30 November
Complete eBallot
13 December
Ratification & publication
21 December
Highlights
Group completed work on time
Application Standard was ratified on 21 December and published on 04 January
The group is now closed
Risks & issues
None at this time
Legend N
Not started G
On schedule Y
Minor risk/~10% behind schedule R
Significant risk/10%+ behind schedule C
Complete