On 29 September 2023, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published further guidance (“MHRA Guidance”) on changes to labelling and packaging for medicinal products intended for the UK market (including Northern Ireland) under the Windsor Framework (agreed between the UK and the EU on 27 February 2023, please see our client alert here).
The MHRA Guidance follows the Agency’s announcement of new labelling and packaging measures in June 2023, which will take effect from 1 January 2025. The new measures require, amongst other things: (i) medicinal products intended for the UK market to be authorized by the MHRA; (ii) a single UK-wide pack that bears a “UK only” label; and (iii) disapplication of the EU Falsified Medicines Directive 2011/62/EU (“EU FMD”) to UK packs (please see our blog post on this announcement here).
The latest MHRA Guidance provides further detail on the above measures.Continue Reading New MHRA Guidance on the Windsor Framework: Detail on Labelling and Packaging Changes