The Windsor Framework; Packaging and Labelling Requirements – Aug 2023

From the 1st of January 2025 the supply of medicines to Northern Ireland will be governed by the Windsor Framework, which will replace the Northern Ireland Protocol.

The .gov.uk website (link below) states the following:

‘In 2025, new arrangements for the supply of medicines into Northern Ireland will take effect, ensuring that medicines available in Northern Ireland are those approved by UK authorities, enabling a single licence and a single pack for medicines right across the United Kingdom’.

This will come as a great relief to many in the pharmaceutical wholesale dealing industry, as it means there will no longer be PLGB and PLNI product licensing differences for medicines and all medicines will be licensed as PLUK. This will obviously dispense with the need for the current MHRA NIMAR list.

From the 1^st January 2025: (taken from .gov.uk link below)

• All new medicines and medicines in Northern Ireland that currently fall under the scope of the EU Central Authorisation Procedure will be authorised by the MHRA for the UK market. Separate guidance will be published on the licensing process that will cover the transition of licences in the coming weeks.
• These products will only be able to be sold in the UK and will not be available on the market in Ireland or elsewhere in the EU, other than available in the EU as ‘specials’ subject to EU rules and conditions.
• Packaging for all products, except products with a parallel import licence (PLPI), which have the option to add the label, for the UK market must carry a clearly legible ‘UK Only’ label for the product to be allowed onto the UK market.

With regards to the Windsor Framework; Packaging and Labelling Requirements – companies will be able to sell through existing stock manufactured before the 1^st January 2025. All PLUK licensed medicines manufactured after that date will need to carry the ‘UK only’ label on the product packaging.

There will be the option up to the 30^th June 2025 to apply a sticker to the product pack, however certain requirements for stickering apply (from gov.uk link below):

• The application of a ‘UK Only’ sticker will need to be done prior to certification by a Qualified Person (QP). The stickering must be completed by the site named on the Marketing Authorisation (MA) prior to QP Certification. Packs released prior to 1 January 2025 can remain without the need to use a sticker or over label.
• The sticker must not cover any statutory text presented on the pack (e.g. batch numbers and expiry date).
• MA holders who initially wish to apply the ‘UK Only’ statement by means of a sticker will need to provide an updated mock-up of the outer packaging to the MHRA, indicating where this will be placed on the carton. The notification process for providing updated mock-ups is described in the section ‘Notification Process’ later in this guidance document. There is no need to register an updated mock-up when the ‘UK Only’ label is subsequently printed directly on the pack. Updated labelling may be provided at the next regulatory opportunity.

For further information see the links below:

www.gov.uk/government/collections/the-windsor-framework-further-detail-and-publications

www.gov.uk/government/publications/labelling-and-packaging-of-medicinal-products-for-human-use-following-agreement-of-the-windsor-framework