Windsor Framework Archives | European Regulatory Affairs Specialists

What it means for your company

Batches of medicinal product, authorised through the centralised procedure (CAP), that are currently lawfully on the market in Northern Ireland may remain so until their Expiry Date
- However, these medicinal products cannot be moved from Northern Ireland to an EU/EEA Member State or be placed on the market in an EU/EEA Member State.
No new batches of authorised CAPs can be released on the market in Northern Ireland after Regulation (EU) 2023/1182 becomes applicable (01Jan2025)
- Therefore the release of CAP medicinal product by your Qualified Person (QP) has to be planned accordingly and cannot be performed after this date.
It is recommended that companies and MAH’s anticipate any potential issues and resolve them in the next 8 months.
There is no possibility of multi-country packs for CAPs between Northern Ireland and any other EU/EEA member state after the regulation becomes applicable.
- Any medicines placed on, or who are currently on the market before this happens may remain so until the expiry date is reached.
The product information (PI) of the CAPs will no longer require the mention of a local representative in Northern Ireland after the regulation becomes applicable.
- The PI can be amended by way of an article 61(3) if no regulatory procedure is planned within 36 months.
- This change should be made at the earliest opportunity.
- The Q&As to stakeholders states ‘Additionally, it is also acceptable to request the deletion of the local representative for Northern Ireland in any regulatory procedure affecting the Annexes of the Marketing Authorisation submitted after 1 July 2024, provided that this change is only implemented after the date that Regulation (EU) 2023/1182 becomes applicable.’

Do you have a product that this may affect? There are lots of tasks that need to be done if so and these should begin this quarter!

The Legal Jargon behind it all

The Windsor Framework is a legal agreement between the European Union and the United Kingdom that was announced on February 27, 2023. It is a political declaration and a series of legal documents reached by the UK and EU in the Withdrawal Agreement Joint Committee. It covers topics such as trade, goods, services, sanitary and phytosanitary measures, and the democratic consent mechanism. The Framework was formally adopted by both parties on March 24, 2023, and came into effect on October 1, 2023.

Regulation (EU) 2023/1182 is a legal document that was passed by the European Parliament and the Council on June 14, 2023. It contains specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amends Directive 2001/83/EC. The regulation is aimed at ensuring that medicinal products placed on the market in Northern Ireland comply with the provisions of Union law. This has resulted in increased costs and red tape for GB-based pharmaceutical manufacturers and suppliers who are required to meet EU testing and labelling requirements in addition to UK rules.

Regulation (EU) 2023/1182 came into force on June 20, 2023 1. However, it is not applicable until January 1, 2025, provided that the UK has provided the written guarantees referred to in Article 8 of that Regulation.

This can impact centralised procedures (CAPs) as medicines can now only be placed on the market in Northern Ireland if authorised by the UK authorities in accordance with the law of the United Kingdom and under the terms of the authorisation granted by them.

Pursuant to Article 13 of Regulation (EU) 2023/1182, Article 5a of Directive 2001/83/EC is deleted with effect from the date on which the Regulation becomes applicable (01Jan2025). Article 5a allowed for the medicinal products to be temporarily authorised to supply to in Northern Ireland of a medicinal product belonging to the categories referred to in Article 3(1) and (2) of Regulation (EC) No 726/2004 provided that certain conditions were fulfilled.

If you need assistance with any of the above, contact us.

Written by

Emily Fletcher

Emily Fletcher 1

Initially this is what you need to know:

From the implementation of the Windsor Framework on 1 January 2025, the MHRA will regulate medicines across a UK-wide licensing regime.
Most new Marketing Authorisation Applications (MAAs) will be granted as PL licences covering the whole of the UK.
The MA number will have just a PL prefix (as it was before Brexit).

No action is necessary for this conversion for Marketing Authorisation Holders who only hold a PLGB licence for a particular product.

If a MAH currently holds both a PLNI and a PLGB for the same product and wishes to retain UK-wide authorisation, the PLNI will need to be cancelled in order for the existing PLGB to be converted to a PL.

Where an MAH only holds a PLNI and subsequently seeks authorisation for the whole of the UK, the PLNI will need to be cancelled prior to the granting of the PL.

MAHs involved in EU procedures, with NI included as a CMS, will need to notify the RMS to withdraw NI as a CMS from the procedure. This must occur before the cancellation of the PLNI and the granting of the new PL.

‘UK Only’ is required to be printed on the UK packaging from 01Jan2025, a sticker is allowed to be placed on packaging for a period of 6 months (until 30June2025) but this must be replaced with direct printing on the packaging after this.
And from 1 January 2025, the EU Falsified Medicines Directive (FMD) will no longer apply in Northern Ireland.
From 1 January features included for the purposes of compliance with EU FMD requirements may be removed or covered.

MHRA Overview:

	Current position	From 1 January 2025	Action required from MAHs
New MAA for product in scope of the Centrally Authorised Procedure	GB: national applications, reliance/recognition applications,	PL EC no longer able to authorise for NI.	For products entering the market from 1 January 2025, MAHs may apply for PL licences only. Must comply with labelling and packaging requirements.
New MAA for product in scope of the Centrally Authorised Procedure	NI: EC authorisation. Supply of GB authorised products may be permitted through routes, e.g., NIMAR, Reg 174, Reg 167.	PL EC no longer able to authorise for NI.	For products entering the market from 1 January 2025, MAHs may apply for PL licences only. Must comply with labelling and packaging requirements.
New MAA for Non-CAP product authorisations	UK-wide authorisation or option to apply for PLGB or PLNI	PL Or PLNI through the MRP/DCP	For products entering the market from 1 January 2025, MAHs may apply for PL licences or PLNI only if using the MRP/DCP. Must comply with labelling and packaging requirements.
Products with existing authorisations granted before 1 January 2025.	UK-wide licence	PL	Must comply with labelling and packaging requirements.
Products with existing authorisations granted before 1 January 2025.	Separate PLGB and PLNI for the same product.	Option A: PL only	By 30 September 2024 the MAH should request that the MHRA cancel the PLNI, effective on 31 December 2024. PLGB licences will convert to PL by 1 January 2025. Must comply with labelling and packaging requirements.
Products with existing authorisations granted before 1 January 2025.	Separate PLGB and PLNI for the same product.	Option B: Retain NI only through the MRP/DCP.	No action required from MAH. PLGB will be cancelled by the MHRA on 31 December 2024 as cannot hold a PL and PLNI simultaneously for the same product. Must comply with labelling and packaging requirements.
Products with existing authorisations granted before 1 January 2025.	PLNI through the MRP/DCP, with no PLGB for the same product.	PLNI through the MRP/DCP only.	Where a MAH subsequently applies for a PL, the PLNI will need to be cancelled prior to the granting of the PL. The MAH should inform the RMS of its intention to withdraw NI as a CMS from the MRP/DCP. Must comply with labelling and packaging requirements.
Products with existing authorisations granted before 1 January 2025.	PLGB only	PL only	No action required from MAH. PLGBs will be converted to PL by 1 Jan 2025. Must comply with labelling and packaging requirements.
CAP Bridging Mechanism	Permits supply of GB-licensed product in NI for up to 6 months if no equivalent available.	Not applicable as the MHRA will license novel/CAP medicines in NI through a UK-wide licensing route.	Not applicable.
Existing Stock in Existing Packaging on the market	Continues as currently.	Can continue to be supplied to patients until the product’s date of expiry in the territory for which the product was valid for supply prior to 1 Jan 2025.	Not applicable.

More on Windsor Framework in the weeks to come……

If you need any help to navigate this new min field of UK updates, don’t hesitate to contact us for support.

Written by

Emily Fletcher

Emily Fletcher 1

Tag Archive for: Windsor Framework

UK Updates – Windsor Framework and Regulation (EU) 2023/1182 for Centralised Products

UK updates to your Medicine – Windsor Framework and Regulation (EU) 2023/1182

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