The EU and UK have agreed major changes to the regulation of medicines in Northern Ireland (NI). The package of measures would simplify marketing authorisation (MA) arrangements for NI and the wider UK, with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) being responsible for authorising all medicines for the NI market. The package also includes measures to reduce the regulatory burden on supply chains involving supply of medicines from Great Britain (GB) to NI.

The changes have been agreed as part of the negotiations leading to the so-called Windsor Framework, the name for the revised Ireland/Northern Ireland Protocol (the Protocol) once it is amended by the package of measures announced on 27 February 2023. Currently, the solutions take the form of a political agreement in principle. The amendments to the Protocol will need to be adopted by the Joint Committee established under the Withdrawal Agreement between the EU and UK. Aspects of the agreed solutions will need to be implemented through legislative changes in each of the UK and the EU.

What is the current position for human medicines in Northern Ireland?

Currently, through the operation of the Protocol, the EU pharmaceutical regulatory framework applies to and in NI[1]. The MHRA acts as the competent authority to apply and enforce the EU pharmaceutical regulatory framework in NI.

Depending on the status of a particular medicine, it can be authorised in NI by either:

• a centrally authorised procedure MA (CAP MA) granted by the European Commission;
• a UKMA (NI) granted by the MHRA authorising a medicine in NI; or
• a UKMA (UK) granted by the MHRA authorising a medicine across the UK, including NI.

A medicine may be subject to different MAs in NI and GB and thus different labelling requirements. Given the relatively small size of the NI market, it can be a disproportionate cost for MA holders to comply with the terms of two different MAs and produce different packages and labels for NI compared to GB. This contributed to supply shortages for a large number of medicines in NI.

The majority of medicines available in NI continue to be sourced from GB.

Acknowledging that NI and certain EU countries (Ireland, Malta and Cyprus) had historically been reliant on supply of medicines from GB, the EU previously adopted a set of measures aimed at facilitating the supply of medicines from GB to those markets. This included recognition in those markets of quality control testing and Qualified Person (QP) release performed in GB in accordance with EU law, subject to certain conditions. This was on a temporary basis for the markets other than NI. The EU also temporarily suspended the requirement to decommission the EU unique identifier when a medicine is exported to GB and then issue a new unique identifier when it is subsequently “imported” into NI.

These measures helped reduce the regulatory burden on operating a whole-UK supply chain for a medicine but complexities remained.

What are the key changes in the solutions agreed between the EU and UK?

The European Commission has published a proposal for a Regulation reflecting the solutions agreed between the UK and the EU. This Regulation would suspend the application of certain aspects of EU pharmaceutical law in NI.

Key changes to the regulatory framework applicable in NI include:

• Novel medicines (i.e. those within the mandatory or voluntary scope of Regulation 2004/726) will no longer be authorised in respect of NI via a CAP MA and it would be unlawful to place on the NI market a medicine under a CAP MA[2]. Instead, in-scope medicines will be authorised in respect of NI by the MHRA granting a MA in accordance with the laws of the UK. This will mean there can be one UK-wide MA with one set of labelling requirements.
• To help ensure there is no overspill of a UK-authorised medicine available in NI into EEA States, all medicines intended to be placed on the NI market (NI Medicines) must be clearly labelled “UK only”[3]. It will be unlawful to place NI Medicines on the market in the EEA or move them to an EEA State[4].
• The requirements relating to safety features on packaging and verification of such features by economic operators brought in by the Falsified Medicines Directive[5] and Commission Delegated Regulation 2016/161 will be dis-applied in NI. Together with the above changes, this will mean that pharmaceutical companies only need to produce the one label for medicines to be supplied in both GB and NI. This will also ease the regulatory burden on medicines supply chains involving supply from GB to NI. This should mean the end of SecurMed UK, the UK National Medicines Verification Organisation which runs the National Medicines Verification System in the UK (the verification platform that pharmacies and other registered parties such as wholesalers, self-dispensing doctors and hospital pharmacies use to check the authenticity of a product in the UK), currently only in existence for the NI territory.

The UK must provide written guarantees to the European Commission that the placing on the market of NI Medicines does not increase the risk to public health in the EU internal market and such medicines will not be moved to a EU Member State. This must include guarantees that: (i) economic operators will comply with the new labelling requirements; and (ii) there is effective monitoring and enforcement of the new rules, including through inspections and audits.

The Commission would be empowered to suspend the application of the new rules (in whole or in part) if the UK fails to take appropriate measures to address serious or repeated infringements. Before suspending the new rules, the Commission must follow a procedure involving pre-notification to, and consultation with, the UK, with a view to allowing the UK to first remedy the situation.

What will stay the same?

Except as specifically modified by the proposed Regulation, EU law on medicines will continue to apply to and in NI[6]. This will mean MA holders and other economic operators will need to comply with EU rules relating to, amongst other things, the manufacture and distribution of medicines and pharmacovigilance when supplying medicines to NI. The proposed Regulation will, however, conserve recognition of GB quality control testing and QP release for the NI market, allowing medicines to be ‘imported’ to NI from GB by a wholesale dealer authorisation holder without the need for a manufacturing authorisation.

The exception to EU law that medicines may be placed on the market in NI when licensed in accordance with the law of the United Kingdom only applies to medicines within the mandatory or voluntary scope of Regulation 2004/726. Therefore, medicines outside of this scope would still require a MA granted in accordance with Directive 2001/83 as transposed into domestic law as it applies in NI.

Both the proposed EU Regulation and the documents published on the Windsor Framework are silent on the application to NI of the decentralised procedure (DCP) and mutual recognition procedure (MRP). It therefore appears that the current position could continue, i.e. that the UK may be named as a Concerned Member State in respect of NI with a separate MA required for GB. However, pharmaceutical companies can opt to apply for a whole-UK authorisation rather than include NI in a DCP or MRP if this would make supplying to the UK easier.

Neither the draft EU Regulation nor the political announcements address regulatory data and market exclusivity periods. In principle, it is possible that these periods could still differ between NI and GB, meaning a generic medicine could not be placed on the market UK-wide while the market exclusivity period for a reference medicinal product applies in one part of the UK.

Next steps and conclusion

The Joint Committee under the Withdrawal Agreement is expected to adopt the amendments to the Protocol at its March meeting.

The UK government intends to submit the overall Windsor Framework package for UK Parliamentary approval. There is little doubt the package will be approved by Parliament.

Much of the detail of how the specific measures relating to medicines will work in practice in NI will need to be implemented through amendments to UK legislation. A draft statutory instrument is yet to be published so we await the full details of the implementation.

The Commission’s proposed EU Regulation modifying the application of the EU medicines regulatory framework to NI will need to be adopted by both the European Council and the Parliament.

If adopted unchanged, the proposed EU Regulation would apply from 1 January 2025 provided the UK has given the written guarantees mentioned above. If the UK gives the written guarantees earlier, the Regulation would apply from the first day of the calendar month after the one in which they are given. This means that it could apply at relatively short notice so pharmaceutical companies should stay alert to this and seek through industry bodies that the UK Government gives prior warning.

—————
[1] Article 5(4) and Annex II of the Protocol
[2] Article 4 of the proposed EU Regulation on specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland (the “proposed EU Regulation”)
[3] Article 5 of the proposed EU Regulation
[4] Article 7 of the proposed EU Regulation
[5] EU Directive 2011/62 amending Directive 2001/83
[6] Article 1(3) of the proposed EU Regulation