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The Medicines & Healthcare products Regulatory Agency (MHRA) recently published new regulatory guidance for human medicine wholesalers and manufacturers operating within the United Kingdom (UK). Taking effect on 1 January 2025, it introduces a ‘UK only’ labelling mandate for all UK human medicinal products licenced by the MHRA in order to prevent export of these medicines into the European Union or European Economic Area.
The guidance, which aims to implement the arrangements for human medicines as set out in the Windsor Framework, should be read in conjunction with the labelling and packaging guidance and associated Q&As, UK-wide licensing guidance and other relevant MHRA guidance. It is especially relevant to marketing authorisation holders (MAHs), qualified persons (QPs), responsible persons (RPs) and responsible persons for import (RPis).
The primary measures included in the guidance mean that, from 1 January 2025, all medicines in Northen Ireland currently falling under the EU Centralised Authorisation Procedure will now be licenced by the MHRA for the UK market. Furthermore, all MHRA-licenced medicines will only be available in the UK and its export markets. To reflect this, products released from 1 January 2025 must have the ‘UK only’ statement on the outer packaging.
Stickering of ‘UK only’ prior to certification by a QP is allowed until 30 June 2025, but this statement must thereafter be printed directly onto the outer packaging. Due to this, joint packs between the UK and EU will no longer be possible.
MAHs will need to notify the MHRA before implementing the artwork changes and communicate these to manufacturers in sufficient time to make sure that correct labelling and product information is included on all batches.
The new guidance also covers the dissolution of the Falsified Medicines Directive (FMD), which has not applied in Great Britain since 31 December 2020 (Brexit) and will no longer apply in Northern Ireland either from 1 January 2025. The FMD meant that all medicines had a unique code which had to be tracked, verified and decommissioned as they were dispensed.
