The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) urges remaining marketing authorization holders to be ready for the upcoming packaging and labeling regulations. Despite most of the industry demonstrating a high level of preparedness, this final call serves as a reminder to ensure all necessary updates are completed.
A significant number of companies have already submitted updated packaging designs to align with the Windsor Framework’s guidelines, MHRA announced today, emphasizing the importance for marketing authorization holders to act promptly in preparing for the December 31, 2024, deadline.
As of January 1, 2025, the MHRA will regulate all medicines available in Northern Ireland under a UK-wide license. Medicines sold in the UK must include a ‘UK Only’ label to indicate their limitation to the UK market, excluding EU countries.
Julian Beach, MHRA’s interim executive director of Healthcare Quality and Access, expressed appreciation for the many marketing authorization holders (MAHs) who have already submitted their revised packaging designs. “With the deadline approaching, only a short period remains to finalize the Windsor Framework’s new medicine regulations, providing a viable solution for medicine supplies to Northern Ireland,” he stated. He encouraged any remaining companies to promptly submit their updates or reach out for assistance if needed.
Considerable progress has been made to prepare for the upcoming January 1 deadline. The MHRA has received label updates from nearly 90% of medicines on the market, but suppliers for the remaining stock should accelerate their efforts.
Despite transition measures allowing previously released medicines without the updated labels, the new packaging policies will take effect as soon as they’ve expired.
To adhere to the January 1, 2025 implementation target, the MHRA suggests two methods for MAHs to submit artwork updates efficiently:
1. **Self-Certification Notification:** Utilize the MHRA’s regulatory management system to submit a self-certification notification specifically for Windsor Framework artwork changes. This method allows an immediate change implementation once the application is submitted, bypassing the usual 6-month approval period.
2. **Artwork Submission Without Updated eCTD Sequence:** Submit packaging changes by December 31, 2024, followed by a complete eCTD sequence update by the end of the following year.
Once these new regulations are in place, the EU Falsified Medicines Directive (FMD) safety features will cease in Northern Ireland.
For details on compliance with UK laws regarding the packaging information encoding and barcodes, refer to section 6 of the MHRA’s labeling guidance. The UK FMD national medicines verification system (NMVS), known as ‘SecurMed,’ will discontinue access after 11 pm on December 31, 2024.
Manufacturers, wholesalers, and dispensing points, including their software providers, should prepare for this transition as outlined in section 3.2 of the MHRA’s guidance.
Medicines in existing packaging certified by a Qualified Person before January 1, 2025, can continue to be supplied until their expiry, with no need for additional verification or decommissioning beyond this date.
For extra support, marketing authorization holders can reach out via email at [email protected]
The MHRA oversees the regulation of medicines and medical devices across the UK, ensuring their effectiveness and safety. This is achieved through well-researched and informed decisions to maintain safety in balance with benefits. As an executive agency of the Department of Health and Social Care, MHRA ensures reliable health standards.
The Commission on Human Medicines (CHM) serves as an advisory body, offering guidance on medicinal product safety, quality, and efficacy, under the sponsorship of the Department of Health and Social Care.