As the pharmaceutical industry adjusts to the further changes the Windsor Framework will bring, there are important changes ahead for parallel import licensing across the UK. The transition from Parallel Distribution Notices (PDNs) to Parallel Import Licences (PLPIs) has introduced new requirements that will impact parallel distributors in Great Britain and Northern Ireland.
In Great Britain, PDNs have already been replaced by PLPIs, allowing products to be marketed exclusively within the region. However, with the implementation of the Windsor Framework on 1 January 2025, the licensing authority will extend across the entire UK, effectively making PDNs obsolete in Northern Ireland. This shift means that all parallel imports, including EU centrally authorised products, will require a valid PLPI licence for UK-wide authorisation.
One of the most notable changes involves the introduction of the “UK Only” label on medicinal products. This requirement ensures that medicines are exclusively designated for the UK market and prevents their return to any part of the European Union. All new packs must display this label as of 1 January 2025. PLPI licence holders have options to incorporate this label either through stickering or direct printing on the packaging, depending on their needs and available space. However, the sticker option is for a limited time period of 6 months, to 30 June 2025. After this date, ‘UK Only’ must be printed directly onto the packaging.
Another significant adjustment relates to compliance with the EU Falsified Medicines Directive (FMD). Starting 1 January 2025, the EU FMD will no longer apply in Northern Ireland and PLPI licence holders shall ensure compliance with the new requirements under UK law, including removing or covering any 2D barcode encoding an alphanumeric character sequence.
To facilitate this transition, companies can begin implementing changes now and are encouraged to adhere to the new requirements ahead of the commencement date.
A helpful overview table of the new labelling and packaging requirements is provided in the guidance available here. For further information please feel free to contact Julia Gillert, Jaspreet Takhar or Elina Angeloudi from our London office.
