EMA Updated the Timeline for IDMP SPOR

EMA updated the timeline for IDMP SPOR in February 2017. In October 2016 SPOR stakeholders were informed of a delay of the RMS / OMS UAT and the impact on the go-live date. The main reason behind the delay and the re-planning activity was an urgent requirement to allocate more time to improve stability and performance of the system before opening it to the external network. EMA has made the progress to improve the stability and performance and completed the re-planning exercise. Therefore the current plan foresees:

• RMS and OMS EMA internal UAT taking place in March 2017
• RMS and OMS external UAT, where NCAs are involved, taking place in April 2017
• RMS and OMS external go live expected in May 2017

Key SPOR milestones in 2017

Impacts at go live of RMS and OMS

• At RMS and OMS go-live, R & O data submission processes will continue as before – no immediate process changes for stakeholders
• Some changes in the current submission processes are being explored
• consultation taking place with Art 57 IWG on Art 57 submission process (enforcement of R & O pre-registration)
• More information will be provided through SPOR Change Liaison Network to explain any applicable process changes and timings
• Any change requests submitted for R & O will be validated by EMA data stewards following the agreed process

SPOR high level timelines 2017 – 2019

NCAs and Industry involvement throughout SPOR

For detailed information on IDMP SPOR click here

Source: IDMP1