The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released 2 updated essential guidances "Wholesalers & manufacturers guidance following agreement of the Windsor Framework" and "Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework" for medicinal products post-Brexit, ensuring compliance with both UK and EU regulations. These new rules apply to products distributed in the UK and Northern Ireland, and companies need to be well-informed to avoid potential disruptions in their supply chains.
The Windsor Framework is named after Windsor, the location where the UK Prime Minister and the President of the European Commission met to finalize the agreement. Windsor Framework outlines the new regulatory approach for medicines and medical devices in Northern Ireland, post-Brexit. This framework replaces the Northern Ireland Protocol and addresses concerns regarding the movement of goods, including medical products, between Great Britain (GB) and Northern Ireland (NI).
This guidance is intended to assist manufacturers and wholesale dealers authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) and the associated Qualified Persons (QPs), Responsible Persons (RPs) and Responsible Persons for Import (RPis) in implementing the arrangements of the Windsor Framework for human medicines.
Marketing Authorisation Holders (MAH) must communicate any changes to the manufacturer promptly so that the manufacturer can ensure all batches it produces have the correct labelling and product information. All medicines on the UK market must be labelled as ‘UK Only’ in order to prevent onward movement into any part of the European Union or the European Economic Area (EEA) and ensure medicines are packaged and labeled the same across the UK.
These measures will take effect on 1 January 2025.
The purpose of this guidance is to provide information regarding the implementation of labeling and packaging requirements for medicinal products for human consumption following the Windsor Framework's agreement.
Medicinal products intended for distribution within the UK market will now need a ‘UK Only’ label. This label distinguishes the product from those intended for the EU market, reflecting the post-Brexit regulatory divergence. Key details include:
Distinct product identifiers
Clear labelling of ‘UK Only’
Specific licence number (PLGB)
To simplify the transition, the MHRA allows the use of stickers to update product labelling for UK-specific information, as long as the original packaging remains compliant with overall regulatory requirements. Pharmaceutical companies can now opt for early release of medicinal products to the market under specific circumstances.
Under the Windsor Framework, a notification process is required for any changes to labelling or packaging for medicines distributed in the UK and Northern Ireland. For more details, pharmaceutical companies can refer to the MHRA’s comprehensive guidance documents:
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