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UK MHRA: Guidance on Labelling & Packaging of Medicinal Products - Windsor Framework

On 27 July 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework" that provides detailed instructions on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.

The Windsor Framework is a collaborative initiative aimed at improving medication safety by enhancing the labeling and packaging of medicinal products for human use.

As part of the Windsor Framework, the MHRA will be able to approve and license medicines across the UK on a national basis, with medicines using the same packaging and labeling across the country, and MHRA will not be required to apply false medicine requirements for medicines marketed and supplied in Northern Ireland, based on the Falsified Medicines Directive (FMD).

These measures will commence on 1 January 202 and based on the guidance the changes will be as follows

  • MHRA will authorize all new medicines and existing EU Central Authorisation Procedure medicines for the UK market.

  • These products will be exclusive to the UK and not available in Ireland or other EU countries, except as 'specials' under EU rules.

  • Except for products with a parallel import license, all packaging for UK market products must have a clear 'UK Only' label.

The ‘UK Only’ statement can be applied via a sticker for a limited time period of 6 months, to 30 June 2025 and after this date, ‘UK Only’ must be printed directly onto the packaging. From 1 January 2025, the EU Falsified Medicines Directive (FMD) will no longer apply in Northern Ireland.

To know more details on the New Marketing Authorisation applications, Joint EU/UK packs, PLGB licence numbers, etc. click this LINK.


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