On 9 June 2023, the UK Government published further guidance relating to the practical implementation of the Windsor Framework (agreed between the UK and the EU on 27 February 2023, please see our client alert here). This overarching guidance contains further detail from the Medicines and Healthcare products Regulatory Agency (“MHRA”) on the implementation and operation of medicines labelling rules under the Framework (the “MHRA Guidance”).
The MHRA Guidance is light on detail, but provides confirmation and clarification on certain key points (including timings for new UK-wide packaging), which we set out below.
Following the UK’s withdrawal from the EU on 31 January 2020 and the end of the subsequent transition period, the Withdrawal Agreement between the UK and the EU became effective on 1 January 2021. The Northern Ireland Protocol is an integral part of such. This establishes a single regulatory zone on the Island of Ireland, thereby preventing a hard border between Northern Ireland (“NI”) and the Republic of Ireland (“ROI”) by applying specific EU legislation “to and in” NI. The Windsor Framework will lay down new arrangements aimed at addressing the practical challenges encountered with implementing the Northern Ireland Protocol, in particular for goods entering NI from Great Britain (“GB”).
In this vein, the MHRA Guidance suggests that the Windsor Framework “sets out a long-term solution for the supply of medicines into Northern Ireland.”
UK-wide Medicines Packaging
The MHRA Guidance clarifies that medicinal products intended for the UK market (including NI) must: (i) be authorized by the MHRA; and (ii) bear a clear “UK only” label, which may be placed anywhere on the pack. The label must comply with MHRA labelling guidance.
The new labelling requirement means that all medicinal products placed on the UK internal market will have the same packaging and labelling and can move freely between GB and NI. As discussed in our previous client alert here, such products should not be at risk of entering the EU Single Market, but the arrangements potentially create a regulatory border for medicinal products on the Island of Ireland. The MHRA appears to confirm this when it makes clear that products bearing the “UK only” label “will not be available on the market in [the Republic of] Ireland, or elsewhere in the EU.”
Further, the MHRA confirmed that “UK only” medicines packs will not need to comply with the EU Falsified Medicines Directive 2011/62/EU and bear two-dimensional barcodes and serialization numbers. Nonetheless, the MHRA “will expect anti-tamper devices to remain on all medicine packaging.”
The MHRA Guidance confirms that the new measures will be effective from 1 January 2025. This is consistent with Regulation (EU) 2023/1182, which carves-out medicinal products destined for the UK internal market, specifically NI, from the EU pharmaceutical rules. In order to provide a single deadline for new packaging requirements for the UK market, the MHRA will continue to allow manufacturers to supply medicines in legacy EU packaging until 31 December 2024. This provides a further one year extension to the previous deadline of 31 December 2023 that required medicines for GB to be presented in GB compliant packaging.
The MHRA therefore advises that: “UK-based suppliers or distributors of medicines should prepare for different packaging for medicines to be supplied to UK and EU markets from 1 January 2025.”
In addition, the MHRA clarifies that medicine packs already on the UK market and within the supply chain in existing packaging after 1 January 2025 may remain on the market until their expiry date.
Bridging Mechanism for Centrally Authorized Products
Until the implementation of the new measures in January 2025, marketing authorizations (“MAs”) issued by the European Commission through the centralized procedure will continue to be applicable in NI, in accordance with EU law. However, such MAs are not valid in GB, where a separate national application and MA is required.
Where manufacturers accordingly submit parallel MA applications to both the European Medicines Agency and the MHRA, and the latter issues a MA first, the UK Government will introduce a bridging mechanism for NI. In such circumstances, companies will be able to supply a GB-licensed product to NI for a period of six months or until the European Commission grants or refuses a centralized MA for the product, whichever is sooner.
This safeguard is designed to ensure that patients in NI have access to medicinal products at the same time as those in other parts of the UK.
Detailed Guidance to Follow
As noted above, this particular MHRA Guidance provides little detail, but does envisage the publication of further “comprehensive” MHRA advice “in due course.” Such further guidance will provide specifics covering labelling requirements and authorizations for medicines to be marketed in NI, and will be developed based on close engagement with the industry.
While the MHRA Guidance importantly confirms the timeline for the implementation of new medicines rules under the Windsor Framework and indicates that detailed guidance will follow, it provides limited further insights at this stage. Covington will continue to follow developments and provide further updates.
In the meantime, if you would like to discuss the Windsor Framework and what it means for your supply chains, please contact our specialist UK and Irish life sciences regulatory lawyers: Grant Castle and Marie Doyle-Rossi.