New Labelling Requirements for Medicines in Northern Ireland: What You Need to Know
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced significant changes regarding the labelling of medicines in Northern Ireland, following the Windsor Framework. With a deadline of December 31, 2024, for compliance, it is crucial for marketing authorization holders (MAHs) and businesses involved in the supply of medicines to understand these new requirements. This article will break down the key points of the new arrangements and their implications for the pharmaceutical industry.
The MHRA has confirmed that the majority of companies have already submitted updated artwork to meet the new regulations. As of now, nearly 90% of marketed medicines have been updated with a ‘UK Only’ label, which indicates that these products are intended solely for sale within the UK and are not authorized for the European Union market. This significant shift in labelling practices is important to ensure clarity in the distribution of medicines and to maintain compliance with the new regulatory framework.
The new regulations come into effect on January 1, 2025, and are designed to streamline the licensing process for medicines in Northern Ireland. Here are the key points to understand:
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New Licensing Authority: From January 1, 2025, the MHRA will oversee the licensing of all medicines in Northern Ireland under a UK-wide licence. This means that companies must adapt to a new regulatory environment.
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‘UK Only’ Labelling: All medicines intended for the UK market must feature the ‘UK Only’ label or sticker. This is to clarify that these products are not for sale in EU countries.
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Transition Measures: Medicines that are already on the market before January 1, 2025, will still be allowed to be sold without the new labelling until they expire. This provides a buffer period for companies to make the necessary adjustments.
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Submission of Artwork: The MHRA has provided two methods for MAHs to submit their artwork changes. The first is through a self-certification notification, which allows companies to implement changes once the application is submitted, rather than waiting for formal approval. The second method involves submitting artwork changes without an updated electronic Common Technical Document (eCTD) sequence by the end of 2024, followed by an updated eCTD submission by December 2025.
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Falsified Medicines Directive (FMD) Changes: With the new arrangements, the safety features required by the EU FMD will no longer be applicable in Northern Ireland. This includes the closure of the UK FMD national medicines verification system, SecurMed, after December 31, 2024.
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Packaging Requirements: While 2D barcodes and serial numbers are still allowed, they must not be recognized by the European repositories system. Companies need to ensure that any such code is removed or adequately covered.
As the deadline approaches, it is imperative for affected companies to take action promptly. Those who have not yet submitted their updated artwork should do so immediately to avoid disruptions in the supply of their products. The MHRA has offered support for companies needing assistance in the transition process.
In conclusion, the new labelling requirements for medicines in Northern Ireland represent a significant change for the pharmaceutical industry. With the MHRA taking over licensing responsibilities and the introduction of the ‘UK Only’ label, companies must ensure compliance by the end of 2024. By understanding these changes and acting quickly, businesses can navigate this transition smoothly and continue to provide safe and effective medicines to the UK market.
