What is the timeline for changes to Datapharm systems following the Windsor Framework?

Option 1 is the default retirement plan for emc Northern Ireland (emc ni). If you would prefer Datapharm to bulk retire your company’s documents on 2nd January 2025 (Option 2), please contact servicedesk@datapharm.com by 11th December 2024.

Option 1 – emc ni website closes 31st December 2024, documents are retired on 31st March 2025

Date	What Will Happen?	What Does This Mean?
11/12/2024	Final submission date for updates to ni related PILs and RMMs	Any PILS or RMMs submitted to publisher ni after this date will not be actioned
31/12/2024	emc ni will be retired shortly after midday	All traffic will be redirect to a landing page explaining the site retirement and inviting users to go emc for UK safety information
1/1/25 – 30/3/2025	Access available to publisher ni to retire documents in line with your process. pi portal and icomply customers can continue to make SmPC submissions to 21/3/25	SmPCs, PILs and RMMs will remain with a state of ‘Approved’ within the system. They will not be visible on emc ni but it will allow you to manage pi portal and icomply in line with your own process SmPCs can continue to be updated to ensure the latest safety information is available to pi portal and icomply customers
21/3/25	Latest date for submission of SmPCs through publisher ni	After this date any SmPCs submitted will not be actioned
31/3/25	Retirement of all SmPCs, PILs and RMMs hosted on emc ni	ni related PI will no longer be available to the end user ni SmPCs will not be available to assign to PI and will be removed from the icomply App on users’ devices (subject to connectivity and local settings)
31/3/25	publisher ni will be retired	Customer access to publisher ni will be halted, all data will be preserved
Not before 31/3/2025	emc ni will be fully closed	The landing page will be removed, users will not be able to access any pages relating to emc ni. We will provide advance communications of the final date of closure
From 1/4/25	Datapharm systems will be updated	Functionality relating to Northern Ireland will be removed from pi portal and icomply

Option 2 – Option to request that your SmPCs, PILs and RMMs are bulk retired from publisher ni by Datapharm on 2nd January 2025

Date	What Will Happen?	What Does This Mean?
11/12/2024	Final submission date for updates to ni related PILs and RMMs	Any SmPCs, PILS or RMMs submitted to publisher ni after this date will not be actioned
11/12/2024	Final date for requesting early automated retirement of documents in publisher ni	If you request this option we will retire you publisher ni documents on 2^nd January 2025
31/12/24	emc ni will be retired shortly after midday	All traffic will be redirect to a landing page explaining the site retirement and inviting users to go emc for UK safety information
1/1/25 – 30/3/25	Access available to publisher ni	You will be able to access publisher ni but your documents will be retired on your behalf on 2^nd January 2025
2/1/25	Retirement of all SmPCs, PILs and RMMs hosted on emc ni	ni related PI will no longer be available to the end user ni SmPCs will not be available to assign to PI and will be removed from the icomply App on users’ devices (subject to connectivity and local settings)
31/3/25	publisher ni will be retired	Customer access to publisher ni will be halted, all data will be preserved
Not before 31/3/2025	emc ni will be fully closed	The landing page will be removed, users will not be able to access any pages relating to emc ni. We will provide advance communications of the final date of closure
From 1/4/25	Datapharm systems will be updated	Functionality relating to Northern Ireland will be removed from pi portal and icomply