On 27 February 2023, an agreement in principle was reached by the UK and EU, known as the Windsor Agreement, relating to post-Brexit trade issues in Northern Ireland (NI). The principles are expected to be approved shortly by the EU-UK Joint Committee. The UK Government and the EU institutions will then enact legislative measures to make the necessary amendments to their laws.
Following Brexit, from 31 January 2020, the UK is no longer subject to EU single-market rules or the EU legislative framework. However, under the EU-UK Withdrawal Agreement’s Protocol on Ireland and Northern Ireland, NI continues to follow EU rules. This is to avoid customs checks between NI and the Republic of Ireland. In practice, this means that medicinal products on the market in NI must be authorised in line with the EU regime, which no longer applies in Great Britain. This causes difficulties for companies marketing their products in the UK, as different authorisations, following different rules, apply in different parts of the UK. It also means that patients have access to different products in GB or NI.
The current agreement covers a number of sectors, and in relation to medicines, the aim is to simplify supply between GB and NI, and ensure that only one authorisation is needed and one set of rules needs to be followed within the UK. However, much detail still needs to be published so that companies can fully understand the impact of the changes on their medicines supply chains.
Key principles of the Agreement
The headline grabbing part of the deal relates to the “red” and “green” customs lanes that distinguish between goods for the NI market and those for the EU market: a green lane will be introduced for goods moving from GB to NI, with reduced requirements and checks. A red lane will apply where goods are intended for onward supply to the Republic of Ireland, with additional checks as goods enter the EU market.
In relation to medicines, and to overcome the current practical difficulties for the supply of these products, the European Commission has published a proposal for a Regulation that suspends the application of certain EU provisions in relation to medicinal products intended to be placed on the market in NI. In particular, the following has been agreed:
- Centralised marketing authorisations granted by the European Commission will no longer be applicable in NI, and products cannot be placed on the NI market under a centralised MA. Instead, the MHRA will regulate and authorise medicines in NI under a UK-wide marketing authorisation granted in line with UK law. Centrally-authorised products may be placed on the market in NI only if the MHRA has also granted a UK MA for the product.
- Medicines can be imported into NI without the need for a manufacturing import authorisation. This is in line with the derogation that is currently in place until 31 December 2024, and will be made permanent under the current agreement.
- The Falsified Medicines Directive will no longer apply in NI, and safety features should not be included on UK packs.
- UK medicines will need to carry a ‘UK-only’ marking, and one pack can be used across the UK, including NI.
- Companies based in NI will be able to supply medicines in both EU and UK, where the products meet the relevant requirements for the destination market.
- Products that are already on the market when the arrangements come into force do not need to be withdrawn and can remain on the market.
- The MHRA will oversee this process and monitor movement of products to ensure that UK-only products do not enter the EU. As the EU medicines regime only permits the holder of a wholesale distribution authorisation in the EU to distribute a product that has a valid EU MA, this should be able to be controlled.
- These amendments shall apply from 1 January 2025
It is currently unclear how these principles will operate in practice, and how they apply to products that are already on the market. For example, where a product currently has a centralised marketing authorisation, which applies in NI, many companies have also sought an authorisation from the MHRA for Great Britain. It is unclear whether currently granted centralised marketing authorisations will stay in place for NI, or whether there will be an automatic conversation of some GB MAs to UK MAs, or whether companies will be required to make a variation to their GB MAs.
Further, it is not clear from the public documents to what extent NI still needs to follow EU rules, over and above the authorisation requirements set out in the agreement, or whether the provisions set out above mean that only the UK rules need to be followed for these authorisations. As a result, there are practical questions for companies, such as how the pharmacovigilance rules will apply, the relationship between the UK and EU vigilance regime, and to whom reports should be made.
What about medical devices?
The current agreement does not address the supply of medical devices, although such products may be able to benefit from the customs procedures that have been put in place, which will reduce requirements on companies to meet both EU and UK rules.
Regulation (EU) 2023/1182 on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC was published on 14 June 2023.