The Medicines & Healthcare products Regulatory Agency (MHRA) has issued new Guidance on parallel import licencing across the UK to address the change to the special situation of Northern Ireland after implementation of the Windsor Framework on 1 January 2025. The Windsor Framework is the post-Brexit legal agreement between the European Union and the United Kingdom which adjusts the operation of the Northern Ireland Protocol and provides a new set of arrangements to restore the smooth flow of trade within the UK internal market.

Post Brexit under the Northern Ireland Protocol, pharmaceutical products placed on the Northern Ireland market had to comply with EU law. As a result, pharmaceutical products imported into Northern Ireland required a Parallel Distribution Notice (PDN) issued by the European Medicines Agency (EMA) to parallel distributors to allow them to distribute centrally authorised product across the EU. Products imported into Great Britain (GB) post-Brexit have required a Parallel Import Licence (PLPI) in line with the new rules in the UK. However, from the implementation of the Windsor Framework on 1 January 2025, the MHRA will license all medicines across the whole of the UK and PDNs will no longer be valid (or required) in Northern Ireland. This means that:

  • All Parallel Imports will be authorised to be marketed across the whole of the UK.
  • All Parallel Imports will need a valid PLPI licence.
  • All PLPIs with a current territorial limitation of GB will be converted to UK-wide authorisation automatically.

The Guidance provides further detailed information on the implementation of PLPI to Northern Ireland, including:

  • PLGB licence numbers and prefixes: All PLPI licences will continue to have the prefix ‘PLPI’ and the licence number will not change. However, the prefix will become “PLPI.” As a result, packaging materials will need to be amended to include the prefix “PL.”
  • “UK Only” label requirements: The “UK Only” label must be displayed on all UK licensed medicines. MHRA Guidance on the labelling and packaging of medicinal products sets out information on the implementation of labelling and packaging requirements for medicinal products for human use following agreement of the Windsor Framework.
  • Application of “UK Only” statement: For products already on the market, the “UK Only” label should be added “at an appropriate regulatory opportunity where the label documentation is updated.” For product applications after the date of the Guidance the “UK Only” label should be applied to the product at the time of application. All new packs placed on the UK market on or after 1 January 2025 must display a ‘UK Only’ label.
    PLPI licence holders may apply the “UK Only” label, either by stickering or indelibly printing directly on the packaging. The guidance also sets out further information on how the stickering/printing should be undertaken.
  • Disapplication of EU Falsified Medicines Directive (EU FMD) safety features and encoding of pack information under UK law: From 1 January 2025, the EU FMD will no longer apply in Northern Ireland. EU FMD safety features will therefore not apply to parallel import licences. PLPI licence holders must still ensure packs are decommissioned correctly and cannot re-enter the EU supply chain.
  • Supply of existing stock in existing packs. Product stocks in existing packaging already on the market in Northern Ireland and GB can continue to be supplied to patients until the date of their expiry. However, all new packs placed on the UK market on or after 1 January 2025 must display ‘UK Only’ label.
  • Early release to market. Prior to the 1 January 2025 commencement date, updates to labelling and packaging can be made from the date of publication of the Guidance and will be permitted for all PLPI licences. Further details are provided in the Guidance in this regard.

A helpful summary table of labelling and packaging requirements is also provided in the Guidance.

This Guidance provides much needed clarity for parallel traders on the requirements to be undertaken prior to 1 January 2025 and the MHRA has also published further information applicable to human medicines in response to the Winsor Framework, which can be accessed here. Separately, the MHRA has detailed guidance setting out full details on how to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application, which is available  here.

If you have further questions on the Guidance or require assistance on parallel importing generally, please do contact us, we would be happy to assist.