The Windsor Framework sets out the arrangements for the supply of medicinal products into Northern Ireland and comes into effect 1 January 2025. Through the Framework the Medicines and Healthcare Regulatory Agency (MHRA) will be able to licence all medicines for the Northern Ireland market in accordance with UK law on a UK-wide basis. This will enable patients in Northern Ireland to access medicines in the same packs as the rest of the UK[1].
The MHRA published updated guidance on 13 September 2024 providing information on UK-wide licensing, pharmacovigilance, labelling and packaging requirements and the distribution and manufacturing elements in accordance with the Framework[2].
On Thursday 19 September 2024, a webinar was hosted by the MHRA to provide industry with more information surrounding the updated guidance and the importance of the timelines in readiness for the changes.
The key takeaways from the webinar are outlined below.
Implementing the Windsor Framework
The implementation date for the Framework is 1 January 2025 and the MHRA have published a collection of guidance documents of the requirements for industry1.
From the implementation date, all medicines will be licensed on a UK-wide basis and authorizations issued by the European Commission (centrally authorized products) will no longer be valid in Northern Ireland, as the MHRA becomes the sole regulatory authority. As a result, the Windsor Framework will place medicines into one of two categories.
- Category 1 – The products will be authorized UK-wide under UK law. It was noted that a list will be published by the MHRA before the end of 2024. For pharmacovigilance, only UK requirements apply.
- Category 2 – All other products that will comply with applicable EU law and do not fall into mandatory scope of the centralized procedure. For pharmacovigilance, both UK and EU requirements are applicable.
- It was stated in the webinar that from 1 January, new marketing authorization applicants will be asked to assign a category when making a submission. The category will remain fixed for the product lifecycle.
- All existing GB-wide marketing authorizations (MAs) will be valid and will be automatically converted on 1 January 2025. GB-only applications will then not be possible, however Northern Ireland-only is still possible under the mutual recognition process. The PLGB prefix (to identify a product licensed by the MHRA that covers Great Britain only) will not change for existing licenses or any pending applications.
Packaging and labeling requirements
Through the Windsor Framework, the EU Falsified Medicines Directive (FMD) will no longer apply in Northern Ireland as the medicines marketed and supplied in Northern Ireland will be regulated by the MHRA on a UK wide basis. As such, EU FMD packaging, labeling and barcodes for medicines must not appear on medicines being supplied to the UK. If 2D barcodes and serialization numbers are present on artwork, then there must be an assurance that they cannot be recognized by the EU repositories system. It was noted that if existing packs are currently uploaded into the European Medicines Verification Organisation (EMVO) repository they will not need to be decommissioned due to the off-lining of the database in UK.
It was highlighted in the webinar that it is part of the responsibilities of a Responsible Person Import (RPi) to seek assurance that when procuring goods for the UK that these are not recognized in a EMVO repository as the product will not be able to be decommissioned in the UK. This could be through seeking assurances from the Qualified Person (QP) or the RP in the member state that the products are not listed in a repository and 2D serialized barcodes are fully decommissioned. This assurance could also be achieved by the RPi through sampling evidence, auditing, or captured in written agreements. It was highlighted during the presentation that the MHRA continues to encourage the use of anti-tamper devices.
With regards to labeling, all medicines for the UK market must carry a “UK only” label. This label can appear anywhere as long as it is legible and not hidden by other written or pictorial material and should be at least 7-point font in line with current MHRA expectations. For larger products, legibility and clear visibility is key. A sticker can be used for “UK only” for a limited period of 6 months (until 30 June 2025)2. However, it was noted in the webinar ted that this step can only be undertaken by the marketing authorization holder. Where an export pack is the authorized UK pack, the “UK Only” label must be present on the outer packaging. Acceptance of these packs lies with the regulations of the individual country receiving the packs. Note that if packs are produced solely for export then there is no requirement to have “UK Only” labeling on the packs.
Artwork changes need to be notified to the MHRA by 31 December 2024. Updated packaging for PL (for products licensed to cover the whole of the UK) and PLGB packs can be released to market ahead of 1 January 2025. Information that is relevant to EU countries must be removed from the labeling and should be carried out at the same time as adding the “UK only” label. It was noted in the webinar that shared inner packaging components are still permitted. The MHRA advised that, as per Regulation 267 of the Human Medicines Regulation 2012 [3], updated mock-ups of any changes to the current packaging must be submitted to the regulatory authority and that these changes must be approved prior to implementation. During the presentation on labeling and packaging to stakeholders, it was emphasized that, with the deadline for artwork submissions approaching on December 31, 2024, the review from the authorization holder of their submission timings should be expedited. There is some flexibility for self-certification submissions as the proposed changes can be made without receiving formal approval and the updated cartons can be implemented before 1 January 2025. It was stated in the webinar that PL and PLGB updated packs can also be released to market prior to Windsor Framework go-live.
Joint EU / UK packs can no longer enter the supply chain after 1 Jan 2025, however any packs that have been QP released before 31 December 2024 can remain in circulation until their expiry date.
Distribution and manufacturing
From a storage perspective, medicines with UK livery may no longer be stored in Europe or the EEA territories after they are placed on the market. Movement from the single market into the UK and back into Europe is prohibited[4].
UK-only livery does not prevent the export of medicines if allowed by regulatory provisions and not listed on the DHSC (Department of Health & Social Care) banned list for export [5]. The supplying wholesaler or territory sending the product remains responsible. It was stated in the webinar that evidence of compliance will be viewed at inspections.
PLGB medicines that feature on the NIMAR (Northern Ireland MHRA Authorised Route) list can be supplied UK-wide until the expiration date[6].
During the webinar presentation it was advised that UK and EU livery medicines that are imported to GB does require the oversight of the RPi, however UK and EU livery medicine that is imported into Northern Ireland does not require the RPi oversight. Once QP-certified and released then all UK medicines may freely circulate in the UK market.
It was highlighted during the webinar that the MHRA compliance teams will inspect against the Windsor Framework requirements from 1 January 2025.
Summary
Valuable information can be found in the published guidance documents, and the MHRA encouraged the attendees to familiarize themselves with the guidance and be ready for the 1 January 2025 implementation date, as all packs for release after 1 January 2025 need to display the “UK only” label. The MHRA will be carrying out email campaigns on readiness and a further webinar will be conducted on 23 Oct 2024. All stakeholders are encouraged to look out for guidance communication updates.
About the author:
Deborah Harrison has more than 14 years of experience in pharmaceutical supply chain management working in roles within GMP and GDP, with expertise in the storage and distribution of medicinal products including narcotics. Deborah acts as a Responsible Person (RP) and Responsible Person Import (RPi) on Wholesale Dealers Authorisations (UK). Deborah is part of the Cencora Quality & Compliance commercialization readiness team.
[1] The Windsor Framework, New Guidance in accordance with the Windsor Framework. https://www.gov.uk/government/collections/mhra-windsor-framework
[2] Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework – GOV.UK (www.gov.uk)
[3] The Human Medicines Regulations 2012. https://www.legislation.gov.uk/uksi/2012/1916/regulation/267/made
[4] Wholesalers & manufacturers guidance following agreement of the Windsor Framework, Sept 2024. https://www.gov.uk/government/publications/wholesalers-manufacturers-guidance-following-agreement-of-the-windsor-framework/wholesalers-manufacturers-guidance-following-agreement-of-the-windsor-framework
[5] Medicines that you cannot export from the UK or hoard. Medicines that you cannot export from the UK or hoard – GOV.UK (www.gov.uk)
[6] The Northern Ireland MHRA Authorised Route (NIMAR). https://www.gov.uk/government/publications/the-northern-ireland-mhra-authorised-route-nimar/the-northern-ireland-mhra-authorised-route-nimar
