Navigating Medicinal Product Labelling Changes: Insights from the UK MHRA Guidance under the Windsor Framework
On 29 September 2023, the UK Medicines and Healthcare Products Regulatory Agency (“MHRA”) published further guidance (“MHRA Guidance”) on changes to labelling and packaging for medicinal products intended for the UK market (including Northern Ireland) under the Windsor Framework (agreed between the UK and the EU on 27 February 2023).
The MHRA Guidance follows the Agency’s announcement of new labelling and packaging measures in June 2023, which will take effect from 1 January 2025.
The new measures require, amongst other things:
- medicinal products intended for the UK market to be authorized by the MHRA;
- a single UK-wide pack that bears a “UK only” label;
- disapplication of the EU Falsified Medicines Directive 2011/62/EU (“EU FMD”) to UK packs.
Early Implementation
As of 29 September 2023, MAHs may begin making the labelling changes required under the Windsor Framework for UK-wide and Great Britain (“GB”) licensed products.
However, while the packs of UK-wide licensed products (i.e., those to be marketed in both GB and NI) can be updated to display the “UK only” label before 1 January 2025, they must also remain compliant with the requirements of the EU FMD until this date (as this continues to apply in NI until 1 January 2025).
From 1 January 2025, in order to enable medicines to use the same packaging and labelling across the UK, packaging for all UK medicinal products (Prescription Only Medicine and Pharmacy and General Sales List) must carry a clearly legible ‘UK Only’ label to be placed on the UK market. The MHRA Guidance explains that stickering (i.e., the application of a sticker to a medicine’s packaging) is permissible with respect of the “UK only” label until 30 June 2025. After this date, companies will be required to print the “UK only” label directly onto the packaging.
Disapplication of the EU Falsified Medicines Directive
The EU Falsified Medicines Directive (FMD) places an obligation on manufacturers of prescription-only medicinal products supplied in EU/EEA (and currently also NI) to apply certain safety features to reduce the risk of falsified (“fake”) medicines entering the supply chain. The EU Falsified Medicines Directive does not apply in GB and will cease to apply in NI from 1 January 2025. This means that serialization codes, included on a medicine’s outer packaging and registered with the European Medicines Verification Organisation (EMVO) for compliance with the EU Falsified Medicines Directive, will not be permitted in GB or NI. Marketing Authorisation Holders must therefore ensure these codes are removed or covered in any new UK packs from January 2025.
Marketing Authorisation Holders can however, use similar coding that may be embedded in 2D barcodes (including expiry date, batch number, Global Trade Item Number) and serial numbers that have not been uploaded to the European Medicines Verification Organisation repository. The MHRA continues to encourage the use of other safety features such as anti-tamper devices.
The requirements are diverse and could look challenging in the first place. If you need more information regarding the regulatory compliance in United Kingdom, schedule a meeting with our experts at marketing@softgroup.eu
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