Windsor Framework - Future of emc ni

 

The Windsor Framework establishes a long-term solution for the supply of medicines into Northern Ireland.  Effective from 1 January 2025, the implementation of the Windsor Framework means that medicinal products are licensed UK-wide by the Medicines and Healthcare products Regulatory Agency (MHRA). This document outlines the impact of the Windsor Framework on emc Northern Ireland (emc ni), operated by Datapharm.

 

For guidance on implementing the Windsor Framework, please consult the MHRA.

 

What is the guidance from the MHRA regarding the Windsor Framework?

A From 1 January 2025, the implementation of the Windsor Framework means that medicinal products will be licensed UK-wide by the UK regulator; the Medicines and Healthcare products Regulatory Agency (MHRA). GB-only licensed medicinal products (PLGBs) will be converted to UK-wide licences meaning these products may be supplied across the UK market. Therefore, information contained within the SmPC, PIL and RMM will be relevant UK-wide from 1 January 2025.

There will be a period of time where packs released to the market prior to the implementation of the framework will circulate until the date of their expiry or until they are dispensed, whichever comes first. If new safety information becomes available after 1 January 2025, then this information will be relevant UK-wide rather than specifically being applicable to NI. The product literature (SmPC and PIL) that will be updated will be that of the UK-wide MA. The product literature approved through the European Medicines Agency for the EU and applicable in Northern Ireland until and including 31 December 2024 will not be valid from 1 January 2025 and cannot be updated.

In specific circumstances, a NI-only licence (PLNI) may be issued through the decentralised or mutual recognition procedures (MRP/DCP). However, we expect the number of these products to be limited.

More detail on licensing following 1 January is set out in our UK-wide licencing guidance published by MHRA here.

 

How will the Windsor Framework affect emc ni?

MHRA have provided guidance following the publication of the Windsor Framework around how marketing authorisations will be handled from 1^st January 2025 which states that medicinal products will be licensed UK-wide and centrally approved products will no longer be valid in Northern Ireland. In light of that information we have taken the decision to retire emc ni.

 

When will emc ni be closed?

emc ni will be closed at midday on 31^st December 2024 

 

How will the closure take place?

Shortly after midday on 31^st December 2024 all traffic to emc ni (emc northern ireland) will be directed to a landing page that details that the site is no longer available following implementation of the Windsor Framework. It will invite users to go to emc (medicines.org.uk) where medicines information for UK-wide products can be found. Due to how the internet works, it may take a few hours for users to be redirected to the landing page after the site has been closed. 

 

What will happen if I have provided links to SmPCs, PILs or RMMs that are currently hosted on emc ni?

All traffic to emc ni will be directed to a landing page detailing the reasoning for the site closure and inviting users to go to emc (medicines.org.uk) where medicines information for UK-wide products can be found.

 

Do I need to retire SmPCs, PILs and/or RMMs on 31^st December 2024 so as they are no longer viewable? 

 No. As all traffic to emc ni will be directed to a landing page users will not be able to access information once the site has been retired. 

 

When will emc ni documents (SmPCs, PILS & RMMs) be retired?

 Access to publisher ni will be maintained until 31^st March 2025. You can manage your document retirement at any point up to this date, we will then automate retirement of all documents related to emc ni on 31^st March 2025. 

 

I would like my Northern Ireland documents to be retired sooner. Can this happen? 

Yes, you can manually retire you documents in publisher ni at any time up to 31^st March 2025. Any documents not retired by this time will be automatically retired by Datapharm. Alternatively, we can bulk retire all of your documents on 2^nd January 2025. If you wish to take advantage of this then let us know by contacting servicedesk@datapharm.com by 11^th December 2025 

 

How long will the landing page be available? 

The landing page will be available until at least the 31^st March 2025. We will provide communication ahead of when the landing page will be ceased.

 

Why is Google, or other search engines, still providing links to emc ni in search results? 

Search engines hold information through crawling the site or by following links from other sites. We do not control how search engines store information and it can take time for them to learn that the site is no longer available. Although a link may be present in search results the user will not be able to access it on emc ni after the site has been retired.

 

Can I still access publisher ni?

 Access to publisher ni will remain available until 31^st March 2025. After this date customers will not be able to access the system. Datapharm will archive the data and, on request, can provide customers with access to this information. 

 

When is the last date I can submit documents for publishing on emc ni?

 Patient Leaflets and RMMs can be submitted up to 11^th December 2024. If they are submitted after this date they will not be actioned, this is to allow for processing time and extended SLA over the Christmas and New Year period. If you have any urgent safety updates after this date contact servicedesk@datapharm. For SmPCs, we will accept submissions up to 21^st March 2025. Although they will not be accessible on emc ni this will allow customers of pi portal to ensure that any PI based on EU approved SmPCs will be aligned with the latest safety information. It will also enable users of icomply to have the most recent safety information on their device.

 

Where can I get information about the impact of the Windsor Framework on promotional material in relation to the ABPI Code? 

For information in relation to the ABPI Code, please refer to the PMCPA guidance that has been published on the PMCPA website.

 

What happens to prescribing information for NI that I have created in emc pi portal?

Prescribing information published through emc pi portal will continue to be available until either it is ‘un-published’ through the pi portal user interface or until the associated SmPC is retired using emc publisher ni. You can manage your prescribing information through pi portal as normal up to the end of March 2025. We will automate retirement of all emc ni SmPCs, PILs and RMMs on 31^st March 2025, this will have the effect of removing the prescribing information from emc pi portal. This means

• The prescribing information will no longer be available to the end user, they will be presented with a page informing that the information is no longer available
• SmPCs related to emc ni will no longer be available to assign to PI
• Entries will be made in the Audit log detailing the retirement

 

What happens to emc ni information in icomply?

 Northern Ireland specific SmPCs that have been assigned to icomply users will continue to be available until either it is unassigned through the icomply user interface or until the associated SmPC is retired using emc publisher ni. You can a manage the assignment of Northern Ireland SmPCs to icomply users as normal up to the end of March 2025. We will automate retirement of all emc ni SmPCs, PILs and RMMs on 31^st March 2025, this have the effect of removing emc ni SmPCs from icomply. This means:

• Any emc ni SmPCs will be removed from users’ devices (subject to local device settings and connectivity)
• SmPCs related to emc ni will no longer be available to assign to users
• Entries will be made in the appropriate report detailing removal of the NI SmPCs as the users’ devices are synchronised

For further guidance of managing user assignments, please visit emc icomply management system -

 

Can I manually update information relating to emc ni in pi portal or icomply?

ni specific information can be manually updated until the point we retire the SmPCs on 31^st March 2025. After this date the information will no longer be available to end users and emc ni SmPCs will not be available for assigning to PI or icomply users. 

 

Why can I see references to Northern Ireland in pi portal and icomply?

We are maintaining functionality related to Northern Ireland in pi portal and icomply to provide a transition period in which users can manage Northern Ireland specific information according to their own process. From 1^st April 2025 we will start removing Northern Ireland specific functionality from pi portal and icomply.

 

How do I change Prescribing Information currently labelled as “For GB” or “For ni”?

Users of pi portal can reference regions in two places, in the PI Name field of single PI, or in the Tab Name field of a Product Group. If you wish to remove or amend references to regionality it can be actioned as follows

Single PI

• Edit the relevant PI and update the name field
• Save the changes
• Publish Update from the Prescribing Information portfolio page for the change to take effect

Group PI

• Edit the relevant Product Group
• Select the relevant region tab
• Use the drop-down to select the new tab name (note: this only changes the tab name in the published PI, not the edit page)
• Save the changes
• Publish Update from the Product Group portfolio page for the change to take effect

 

What does the MHRA say about managing differences in product information between NI and GB?

 

• Differences in product information between the GB (to be UK-wide) MA and EU MA should be managed depending on the situation
• MA holders are not expected to align the EU-MA and GB-MA for 1 January 2025
• MHRA will take a pragmatic approach
  
  
• MA holders only need to communicate differences where this results in a change of clinical practice for healthcare professionals in NI which affects patient safety
• Current advice for Direct to Healthcare Professional Communication (DHPCs) should be followed
  
  
• Safety information which has been included in the EU MA should be included in the GB/UK-wide MA via the variation process, as usual
• Implemented within standard timelines (3-6 months)
  
  
• Contact safetyprojects@mhra.gov.uk for advice on managing the situation on a case-by-case basis

 

What is the timeline for changes to Datapharm systems to implement 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

 

What should customers do if they need to make a PIL or RMM emc ni submission between 11 December and 31 December 2024?

 Contact service desk. We will take a pragmatic approach to any requests. The early date is due to extended SLAs over the Christmas and New Year period.