The vast majority of companies have already submitted updated artwork to ensure compliance with the new arrangements for medicines following the Windsor Framework, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced today as it issues its final call to marketing authorisation holders to take action now in preparedness for the 31 December 2024 deadline.
From 1 January 2025, the MHRA will be responsible for licensing all medicines on the market in Northern Ireland under a UK-wide licence, and all medicines for the UK market must carry a ‘UK Only’ label or sticker to show that they are only for sale within the UK and not in countries inside the European Union (EU).
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said
I would like to thank the large proportion of marketing authorisation holders (MAHs) who have submitted their updated artwork already.
We’re now on the home stretch, with just over a month before the new medicines arrangements of the Windsor Framework are put into practice, providing a solution to the supply of medicines into Northern Ireland.
Any companies that still need to submit updated artwork should do so as soon as possible, and ahead of releasing products on the market in the new year. If you have any difficulty in doing so, we are available to help.
Companies have made strong progress to get ready for 1 January. The MHRA has already received artwork submissions from companies to update their medicines packaging with the ‘UK Only’ label for nearly 90% of marketed medicines. Businesses supplying the remaining medicines now have a little over a month remaining to do so.
Transition measures are also in place and medicines released to the market before 1 January will still be allowed to be supplied without the new labelling until they reach their expiry date.
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
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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.
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Submit artwork changes initially without an updated eCTD sequence by 31 December 2024 and then submit an updated eCTD sequence by 31 December 2025.
The new arrangements that come into place on 1 January 2025 also mean that the EU Falsified Medicines Directive (FMD) safety features will no longer apply in Northern Ireland.
For information on encoding of pack information and barcodes under UK law, please see section 6 of the MHRA’s labelling and packaging guidance. In line with this, the UK FMD national medicines verification system (NMVS) ‘SecurMed’ is closing and there will be no access to this system after 11pm on 31 December 2024.
Manufacturers, wholesalers, dispensing points, and their respective software suppliers should take appropriate steps to prepare for this change. This is set out in section 3.2 of the MHRA’s wholesalers and manufacturers guidance.
UK medicines will not display features included for the purposes of compliance with FMD. The 2D barcodes and serial numbers remain permitted but, when scanned, must not be recognised by the European repositories system, and any such code present would need to be fully removed or covered. Anti-tamper packaging continues to be encouraged.
Packs placed on the market that have been certified by a Qualified Person in existing packaging before 1 January 2025 can continue to be supplied until their expiry date. Verification or de-commissioning of these packs from 1 January 2025 will not be required.
Notes to editors
- Guidance for the labelling and packaging of medicinal products for human use following agreement of the Windsor Framework is available here.
- Further information on the Windsor Framework arrangements for medicines is available here.
- Marketing authorisation holders requiring additional support should email [email protected]
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. The CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care.
- For media enquiries, please contact the news centre on 020 3080 7651 or [email protected]
