On 5 April 2024, the MHRA updated various guidance documents on the impact of the Windsor Agreement (the Agreement) on parallel imports into and within the UK. Since the end of the Brexit transition period, EMA-issued parallel distribution notices (PDNs) ceased to be valid in Great Britain (GB). A PDN must be obtained by a parallel distributor prior to engaging in parallel distribution in the EU. In GB, PDNs were replaced by Parallel Import Licences (PLPIs), which allowed distribution of products in GB only; while PDNs continued to be valid in Northern Ireland (NI).

As of 1 January 2025, when the Agreement is due to take effect, PDNs will no longer be valid in NI. All parallel imports into GB and NI will require a PLPI from the MHRA that will apply across the whole UK, and any PLPIs that were previously limited to GB will automatically convert into UK-wide PLPIs from this date.

Parallel distribution in the EU and UK

The principle of free movement of goods applies generally within the EEA (EU member states, plus Iceland, Liechtenstein and Norway). This means that once a product has been lawfully placed on the EU market, it can be distributed between Member States by third parties, for example, to take advantage of the price differences between Member States. Medicinal products that have been centrally authorised in the EU that are distributed in this way must comply with the EMA’s notification procedure; in particular, the parallel distributor must obtain a PDN from the EMA.

At the end of the Brexit transition period on 1 January 2020, PDNs ceased to be valid in GB and were replaced by PLPIs, which allow medicinal products to be parallel imported and marketed in GB only. Products marketed under a PLPI are currently labelled as “GB Only.” PDNs do, however, currently remain valid in NI and no further regulatory action is required to market products directly imported from the EU into NI.

The Windsor Agreement

As set out in a previous post, the Agreement was entered into between the European Commission and the UK Government in 2023 to resolve issues relating to the supply of goods into NI from the UK. It amended the NI protocol, which came into effect at the end of the Brexit transition period under which NI continued to follow EU rules in order to avoid a border being created on the island of Ireland. However, the NI protocol caused practical difficulties for companies supplying products in the UK, as different regulatory regimes apply. The Agreement seeks to reduce those difficulties, and in particular, will suspend the application of certain EU provisions, which do not apply in GB, in relation to medicinal products intended to be placed on the market in NI.

Since the Agreement was reached, the MHRA has released guidance aimed at assisting industry prepare for the changes. As part of this, on 5 April 2024, the MHRA published a Guidance on UK Parallel Import Licences Following Agreement of the Windsor Framework (Guidance) which sets out the key changes that the Agreement will introduce and the regulatory action that must be taken by PLPI license holders in order to ensure continued and timely compliance.

Parallel trade from January 2025

Under the Guidance, as of 1 January 2025, PDNs will no longer be valid in NI. Instead, all parallel imports will require a PLPI that will apply across the whole UK, and any PLPIs that were previously limited to GB will automatically convert into UK-wide PLPIs. Importantly for companies, no variation application will be required to change the territory of their PLPI from GB to UK.

The Guidance sets out the knock-on effects for licence numbers, packaging and accompanying documentation. For example:

  • All PLPI licences will continue to bear the prefix ‘PLPI’ and their licence numbers will remain unchanged. Any labels/leaflets with the prefix ‘PLGB’ will need to be changed, though no variation will need to be submitted. As a result, PLPI licence holders must amend their products’ packaging and accompanying documentation to bear the applicable prefix.
  • According to the Agreement, medicinal products placed on the market on or after 1 January 2025 must be labelled as “UK Only” in order to prevent any onward circulation back into the EU market. PLPI licence holders may apply the “UK Only” statement by either over-stickering or printing it directly onto the packaging, and must either submit a notification document for stickering or have MHRA-approved labelling prior to 1 January 2025. The “UK only” statement may be affixed at any point prior to 1 January 2025 (though until this date must remain compliant with EU FMD requirements), at which point it becomes mandatory for all new packs placed on the UK market.
  • Any stock of medicinal products in existing packaging that has already been placed on the NI and GB markets prior to 1 January 2025 can continue to be supplied to patients until its expiration date; it will not need to be recalled for repackaging. All new packs placed on the UK market after this date must bear the “UK only” statement.

Disapplication of FMD

A second piece of guidance relates to the disapplication of the EU Falsified Medicines Directive (FMD) in NI. This means that from 1 January 2025, safety features (such as the unique identifier and anti-tampering device) will no longer apply to PLPIs. PLPI holders must take all the relevant steps to ensure that FMD-compliant packs are decommissioned correctly such that they cannot re-enter the EU supply chain, for example, removing or covering any 2D barcodes that have been registered with the European repositories system.