New Year, New UK-Wide Licensing Regime

On January 1, 2025, new UK-wide arrangements for the supply of medicines came into effect on account of the “Windsor Framework.” The overarching aim is to secure the long-term stability of the supply of medicines to Northern Ireland (NI), ensuring that medicines will be available at the same time, and on the same basis, across the whole of the UK.

To do this, the Windsor Framework changes the regulation of medicines that were formerly within the scope of the EU centralized procedure. Beginning January 1, 2025, medicines for supply in the UK are now authorized UK-wide by the Medicines and Healthcare products Regulatory Agency (MHRA) only and therefore, companies will no longer need to apply for, or maintain, separate licenses for Great Britain (GB) and NI to market novel medicines. Other key changes include removing the requirements of the EU Falsified Medicines Directive (FMD) and a requirement that all medicines placed on the UK market be labeled “UK Only.”

While the changes seek to simplify the post-Brexit regime in the UK, in practice, companies may be faced with meeting two sets of requirements depending on the type of product. We set out an overview of the key requirements below, although the changes impact a range of regulatory obligations, and we anticipate further complications in the future when the EU Pharma Package is introduced in the EU. We would be happy to speak further about the detail if you have questions.

Why was change needed?

Post-Brexit, while medicinal products on the market in GB were no longer authorized in line with the EU regime, pursuant to the Northern Ireland Protocol (the Protocol), medicinal products in NI continued to be subject to EU rules. As part of this, novel medicines for supply in NI continued to be approved by the European Commission under the centralized procedure.

The purpose of the Protocol was to avoid customs checks between NI and the Republic of Ireland. However, the approach created complexities for the supply of medicines from GB to NI, the route through which almost all medicines are supplied to NI, and risked companies not supplying medicines in NI due to additional costs and difficulties. As such, the Windsor Framework was agreed to between the EU and the UK in February 2023, to replace the Protocol, in an attempt to safeguard the supply of medicines and public health in NI. For details, see our previous Blog.

The changes have now been introduced by way of the Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (the Amendments) and came into force on January 1, 2025. The MHRA also has a hub for relevant guidance.

UK-wide licensing

Pursuant to the Protocol, the UK licensing authority, the MHRA, was able to grant marketing authorizations (MAs) with three different territorial scopes covering:

• The whole of the UK (UKMA(UK)) with the authorization number prefix “PL”
• NI only (UKMA(NI)) with the authorization number prefix “PLNI”
• GB only (UKMA(GB)) with the authorization number prefix “PLGB”

EU law applied (along with domestic regulations) to the first two of those categories (because EU requirements applied in NI), and UK law only applied to GB authorizations. Medicines authorized under the EU centralized procedure continued to be placed on the market in NI under a centralized authorization granted by the European Commission.

Post January 1, 2025, the MHRA will issue UK-wide licenses for all types of medicinal products, removing the need for GB- and NI-specific licenses (although in some instances these will be maintained).

Product Categorization

The changes introduced by the Windsor Framework apply to medicines that were formerly within the scope of the EU centralized procedure. Therefore, to be clear which rules apply for UK authorizations, all medicinal products that are licensed on a UK-wide basis (existing and new) will receive a new product classification — either Category 1 or Category 2.

Category 1 encompasses medicines that were previously within the mandatory or voluntary scope of the EU’s centralized procedure, and this is the focus of the Windsor Framework:

• Category 1 products include products developed by a biotechnological process, Advanced Therapy Medicinal Products, all new active substance, and orphan drugs.
• Category 1 products also include conditional MAs.
• Category 1 products will be authorized by the MHRA in accordance with UK law.
• Category 1 products include generic, hybrid, or biosimilar products of Category 1 reference products that have been authorized by the MHRA or centrally by the EU, regardless of whether the centralized procedure was used for the generic, hybrid, or biosimilar application in the EU.
• The rules for this category largely mirror those for medicines previously covered by GB-only licenses.

Category 2 medicines are those which do not meet the criteria for Category 1 and are largely left unchanged by the Windsor Framework:

• This covers all products authorized through the decentralized or mutual recognition procedures in the EU, and will include many over-the-counter and generic medicines.
• These medicines will remain subject to certain EU legal requirements, including aspects of pharmacovigilance, such as the submission of Periodic Safety Update Reports, Post Authorization Safety Studies, and Safety Referrals.
• Category 2 products will be authorized by the MHRA in accordance with UK law and applicable EU law on a UK-wide basis.
• The rules for this category largely mirror those for the medicines previously covered by UK-wide licenses.

The MHRA has published lists of Category 1 and Category 2 products, and the categorization will not change through a product’s life cycle.

Except where expressly specified, the following additional changes introduced by the Windsor Framework apply to both Category 1 and Category 2 products.

Existing licenses

• Existing GB product licenses (PLGBs) automatically became UK-wide product licenses on January 1, 2025. Therefore, the territorial scope of these existing licenses changed from GB-only to UK-wide. License numbers, including the prefix, remain unchanged.
  • MA holders (MAHs) must ensure any necessary changes required to the product labeling and packaging are implemented.
• It is no longer possible to hold simultaneously a UK-wide license and a PLGB or PLNI for the same product.
• PLNI products can continue to be supplied to NI after January 1, 2025.
  • Where an MAH holds a PLNI only and subsequently seeks authorization for the whole of the UK, the PLNI will need to be cancelled prior to the granting of the UK-wide marketing authorization.
  • MAHs involved in EU procedures, with NI included as a concerned member state (CMS), will need to notify the reference member state to withdraw NI as a CMS from the procedure. This must occur before the cancellation of the PLNI and the granting of the new UK-wide marketing authorization.
• For existing UK-wide MAs granted through the decentralized or mutual recognition procedures, where NI remains a CMS in the EU procedure, these can continue to be managed in alignment with the EU procedure, unless there is a requirement for UK-specific changes. In that situation, NI will have to be withdrawn from the procedure and the existing UK-wide MA will be managed by the MHRA exclusively as a standalone MA. This is the MHRA’s preferred option, and it is working with companies to remove NI from the EU procedures.

New applications

• All new national approvals will receive a UK-wide license and MAs will have the prefix “PL” in the license number.
• It is no longer possible for an applicant to apply for a PLGB. Although, in exceptional circumstances, the MHRA may elect to grant a PLGB for reasons of public health.
• All new generic, biosimilar, and hybrid applications must cite a UK-wide license as a reference medicinal product:
  • Only reference medicinal products that are, or have been, authorized for at least eight years in the UK (or GB prior to January 1, 2025) will be valid for generic, hybrid, and biosimilar MA applications.

Labeling and packaging requirements

“UK Only”

As of January 1, 2025, in order to enable medicines to use the same packaging and labeling across the UK, packaging for all UK medicinal products must carry a clearly legible “UK Only” label to be placed on the UK market. To satisfy this, a “UK Only” sticker may be applied for a limited time to June 30, 2025.

The MHRA requires sight of all artwork changes for medicinal products supplied to the UK market, and submission of changes should have been made by December 31, 2024.

Disapplication of the EU FMD

The Windsor Framework Amendments disapply various labeling requirements, including some of those implemented by the EU FMD, which continued to apply in NI post-Brexit, but not GB. The FMD measures included requiring a unique identifier that needed to be scanned at various points along the supply chain.

As of January 1, 2025, any features on products for the purposes of compliance with the EU FMD must be removed or fully covered on “UK-only” packs. The FMD system was disapplied UK-wide on December 31, 2024 and the UK repository is no longer available.

Although not legally required, the MHRA encourages anti-tamper devices, such as a 2D barcode or a serial number, to remain on all medicine packaging. Where Qualified Person (QP) batch certification is performed in the EU and packs display a 2D barcode, the Responsible Person for import should confirm that the pack is not recognized by the EU repositories system. Where QP batch certification is performed in the UK and a pack has been imported from the EU, companies should seek written assurances or evidence from suppliers that where a pack displays a 2D barcode, this is not an FMD-compliant barcode, meaning one recognized by the EU repositories system.

Pharmacovigilance

There are differences between Category 1 and Category 2 products for some pharmacovigilance activities. However, in general, the pre-Windsor framework principles for GB continue to apply, but are now largely applicable on a UK-wide basis.

• Category 1 products are required to follow Part 11 of the Human Medicines Regulations, with further pharmacovigilance requirements outlined in Schedule 12A. The pharmacovigilance rules for Category 1 products reflect the previous rules for products in the “PLGB” category.
• Category 2 products are required to follow Part 11 of the Human Medicines Regulations for pharmacovigilance and with further pharmacovigilance requirements outlined in the Commission Implementing Regulation (EU) No. 520/2012. The rules for Category 2 products reflect those in the previous UK-wide “PL” category.

Guidance for wholesalers and manufacturers

There are also various consequential implications for wholesalers and manufacturers after January 1, 2025, largely due to the fact that “UK Only” packs can no longer be placed on the market in the EU. In particular:

• Export activity: A QP can only certify product intended for the UK market that bears the “UK Only” designation on its outer packaging. This is to prevent medicines placed on the market in accordance with the UK legislative framework from entering the EU market. However, stock in existing packaging that has been QP-certified in GB and NI prior to January 1, 2025 can continue to be supplied to patients in the relevant territory until the date of expiry of the medicine.
• Joint packs: Joint EU/UK packs can no longer be QP certified and released into the UK supply chain. However, where already released to market, these packs can continue to be supplied until their expiry date if information relevant to other markets is removed from packs.
• Activities performed in Northern Ireland: NI-based QPs named on a NI Good Manufacturing Practice authorization may continue to perform batch certification for both UK and EU markets where the site of batch release is located within NI. However, NI-based companies using sites in GB for batch release may only release those goods to the UK. Companies located in GB may use any MHRA-approved NI site to facilitate the supply of medicines to the UK, where they are not subject to any other restrictions.
• Storage of medicines: It is no longer possible to utilize European Economic Area (EEA) located storage facilities to store “UK Only” labeled medicines that have been physically placed on the market in the UK. For example, it will no longer be possible to send goods into the EEA from the UK for storage purposes. Batches QP certified prior to January 1, 2025 may continue to be stored at appropriately authorized sites in EEA until supply to the UK.

Advertising and promotion

Following changes made by the Windsor Framework, the vast majority of medicinal products will be authorized UK-wide and, as such, can be advertised UK-wide. There may be exceptional cases where a medicinal product may only be licensed in part of the UK (i.e., GB or NI). In these exceptional cases, a product may only be advertised in the territory where it is licensed. The Prescription Medicines Code Of Practice Authority (PMCPA) has issued guidance for promotional material affected by the Windsor Framework changes. The PMCPA suggests that where the license is not UK-wide, companies should continue to make it clear as to which part of the UK the material relates (e.g., “For NI health professionals only” or “For GB health professionals only”).

From January 1, 2025, the EU license number that was assigned to licenses in respect of NI no longer applies and should be phased out from UK advertisements at the earliest opportunity. Statutory particulars for UK advertisements to Persons Qualified to Prescribe or Supply will need to refer to the appropriate license numbers with the prefixes relevant as of January 1, 2025. However, the PMCPA is providing a grace period, until December 31, 2025, during which it will not consider it a breach of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice if the MA number and/or MAH’s name and address is incorrect for NI. This grace period is subject to the following requirements:

• The rest of the Prescribing Information (PI) is otherwise consistent with the summary of product characteristics (SmPC) in place from January 1, 2025.
• Other changes to the PI have not been needed (in which case the MA number and MAH’s name and address should be updated at that point).
• The PI has an MA number that was accurate as of December 31, 2024.
• From January 1, 2025, the MA holder can still be contacted via the address given in the PI.

If all the criteria above cannot be met, the PMCPA considers that the company should withdraw/amend the promotional material promptly, and at the very latest by January 15, 2025.

The MHRA advises that when companies update the PI, the opportunity should be taken to remove, amend, or clarify any references to territories to avoid any potential confusion. For example, the statement that a product has a GB-wide MA (where it now has a UK-wide MA) and headings that signposted to specific geographical regions at whom the information was targeted may need to be removed.

Advertisements for the UK may continue to be combined with a campaign that may also cover Europe, where product indications remain aligned and where there is no other divergent information that may pose a risk to the safety of the UK public. The use of the same advertisement across Europe would not be possible where the product’s indication(s) differ in the UK from that of other European territory(ies) as such advertisements would not comply with the UK SmPC.

Conclusion

The ABPI has commented that while these amendments are necessary for the government to comply with the requirements of the Windsor Framework, having two categories of products adds complexity. Where companies have large and diverse portfolios, a two-category system creates a complex landscape, as different products may be subject to different regulations.

Additionally, it is currently unclear what future divergence between UK and EU regulations will look like, and whether this will add even further complexity. Both the MHRA and the Department of Health and Social Care have stated that mechanisms will be introduced that provide a forum for the UK and EU to discuss any issues of divergence in regulations. However, with the EU Pharma Package being debated in the EU, divergence seems likely, rather than possible.

Most importantly, and a factor that will be watched closely by both industry and government officials, it is not clear to what extent having to deal with two categories of product will impact the attractiveness of the UK market to businesses or act as a disincentive to invest and bring products to market in the UK. The MHRA has introduced a number of new initiatives to ensure that does not happen, and you can subscribe to our BioSlice Blog for updates as these develop.

© Arnold & Porter Kaye Scholer LLP 2025 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.