13/14 December 2023
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has announced a "long-term solution" of the Windsor Framework for the supply of medicines into Northern Ireland, effective from January 1, 2025. This framework aims to streamline the approval and licensing process for medicines, ensuring a U.K.-wide approach by the MHRA. As part of this initiative, the packaging and labelling of medicines will be standardized across the U.K., enabling the use of the same packaging for all approved medicines.
U.K.-Only Labelling and Market Availability:
Under the new framework, all new medicines introduced to the U.K. market will be authorized by U.K. authorities, necessitating a clear "U.K. only" label on their packaging. This label will signify that the medicines are intended for sale exclusively within the U.K., including Northern Ireland. Consequently, these products will not be available for purchase in Ireland or other European Union (EU) member states.
Flexibility and Transition Period:
To accommodate industry requirements, the MHRA intends to provide flexibility in meeting the new packaging and labelling requirements. The "U.K. only" label may be positioned anywhere on the medicine pack, as long as it adheres to the MHRA's guidelines. Manufacturers will be permitted to supply medicines in legacy EU packaging until December 31, 2024, allowing a smooth transition to the new packaging standards. Medicine packs already on the U.K. market and within the supply chain can remain until their expiration date.
Deviation from EU Falsified Medicines Directive:
Medicines entering Northern Ireland under the Windsor Framework will not require features mandated by the EU Falsified Medicines Directive (FMD), such as 2D barcodes and serialisation numbers compliant with the EU FMD Directive. However, anti-tamper devices will continue to be expected on all medicine packaging to maintain product integrity and safeguard patient safety.
Preparing for Changes:
U.K.-based suppliers and distributors of medicines should prepare for the introduction of different packaging requirements for medicines destined for the U.K. and EU markets from January 1, 2025. The MHRA plans to release comprehensive guidance on the specific requirements.
Continued Support and Safeguards:
Ahead of the full implementation of the Windsor Framework, the Northern Ireland MHRA Authorised Route (NIMAR) will continue to function, ensuring the ongoing supply of medicines into Northern Ireland. Additionally, the U.K. government plans to establish a bridging mechanism that allows companies to supply Northern Ireland with innovative medicines for up to six months after the MHRA licenses a product before the European Medicines Agency (EMA). This measure will ensure uninterrupted access to essential medicines while the new arrangements take effect.
Industry Engagement and Next Steps:
The Department of Health and Social Care (DHSC) and the MHRA will maintain close engagement with the industry throughout the implementation of the Windsor Framework. As further guidance and operational arrangements are developed, stakeholders will be involved in shaping the next steps, ensuring a collaborative and efficient transition.