The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued "Call to comply with Windsor Framework arrangements for medicines from January 2025" a critical reminder for pharmaceutical companies and stakeholders to comply with the Windsor Framework arrangements for medicines fully. Effective January 1, 2025, these changes aim to streamline regulatory practices while ensuring continued access to safe and effective medicines across Northern Ireland and Great Britain.
The Windsor Framework replaces the previous Northern Ireland Protocol to address the movement of goods, including medicines, between Great Britain (GB) and Northern Ireland (NI). Under this framework, medicines placed on the market in Northern Ireland must align with UK regulations while recognizing certain EU rules for regulatory consistency.
According to the Medicines and Healthcare Products Regulatory Agency (MHRA), the majority of companies have already submitted revised artwork to ensure compliance with the new arrangements for medicines following the Windsor Framework. As it makes its final call to marketing authorization holders, it urges them to act now to meet the deadline of 31 December 2024.
A UK-wide licence will be issued by the MHRA for all medicines on the market in Northern Ireland from 1 January 2025, and all medicines marketed in the UK must bear a ‘UK Only’ label or sticker to indicate that they are only available for sale in the UK and not elsewhere. To meet the implementation date of 1 January 2025, there are two ways the MHRA is recommending MAHs can submit their artwork in time, including a way to make bulk applications:
The easiest and most efficient way to comply is to submit a self-certification notification specifically for the Windsor Framework artwork change to be registered and tracked through the MHRA’s regulatory management system. If updating labelling via the self-certification route, provided the changes are in line with the guidance, companies can implement the proposed changes once the application has been submitted rather than wait for formal approval. The usual 6-month implementation timeline does not apply to this change. Companies can implement updated cartons at any time up to (and including) 31 December 2024.
Submit artwork changes initially without an updated eCTD sequence by 31 December 2024 and then submit an updated eCTD sequence by 31 December 2025.
With the January 2025 deadline fast approaching, companies must act now to ensure full compliance with the Windsor Framework arrangements. These steps will not only uphold patient safety but also reinforce the UK’s position as a leader in regulatory innovation and pharmaceutical excellence.
For more information, visit the official MHRA announcement here.
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