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The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a final call reminding marketing authorization holders (MAHs) to comply with Windsor Framework arrangements before the 31 December 2024 deadline.
Effective 1 January 2025, medicines marketed in Northern Ireland must carry a “UK Only” label. Over 90% of companies have submitted updated packaging, but the remaining holders must act promptly. Transition measures allow pre-2025 stock without new labeling to remain in circulation until expiry.
MHRA provides two key submission options:
Companies can use the self-certification process via the MHRA’s regulatory management system. This allows firms to implement updated Windsor Framework packaging changes immediately after submission without waiting for formal approval, provided they align with guidelines. Unlike typical updates, the standard 6-month timeline does not apply, enabling implementation any time before 31 December 2024.
Companies can first submit artwork changes without an updated eCTD sequence, which must then be submitted by 31 December 2025, ensuring a phased approach to finalizing regulatory submissions.
Starting 1 January 2025, EU Falsified Medicines Directive (FMD) safety features will no longer apply in Northern Ireland, and the UK’s FMD system, SecurMed, will cease operations by 11 PM on 31 December 2024.
Medicines in the UK will not include FMD-specific features, while 2D barcodes and serial numbers remain valid, but they must not be recognized by the EU system. Anti-tamper packaging remains encouraged. Packs certified by a Qualified Person before 1 January 2025 can still be sold until expiry without additional verification or decommissioning requirements.
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