MHRA: Guidance on Labelling/Packaging of Medicinal Products
The UK MHRA has released guidance on the labelling and packaging of medicinal products following the Windsor Framework. It introduces a “UK Only” label and the take over of the MHRA to approve and license medicines across the UK. Furthermore, the application of the EU Falsified Medicines Directive (FMD) in Northern Ireland will no longer apply. The Windsor Framework covers the supply of medicines into Northern Ireland and will replace the current Brexit conditions.
In more detail:
- All new medicines and medicines in Northern Ireland that currently fall under the scope of the EU Central Authorisation Procedure will be authorised by the MHRA for the UK market. These products will only be sold in the UK and are not available in the EU and Ireland, other than categorised as “specials” subject to EU rules.
- From 1 January 2025, packaging for all products for the UK market must carry a clearly legible ‘UK Only’ label for the product to be allowed onto the UK market. The ‘UK Only’ statement can be applied via a sticker for a limited time period of 6 months, to 30 June 2025. Products with a parallel import licence (PLPI), which have the option to add the label are excepted.
- Any stock in existing packaging already placed on the market in Northern Ireland and Great Britain (GB) (in accordance with the relevant rules in Northern Ireland or GB) up until that date (i.e. released by a Qualified Person) can continue to be supplied to patients until the date of their expiry.
- From 1 January 2025, the EU Falsified Medicines Directive (FMD) will no longer apply in Northern Ireland. From then on features included for the purposes of compliance with EU FMD requirements may be removed. However, companies are encouraged to further use anti-tamper packaging.
The timeline:
- To provide a single deadline for new packaging requirements, the MHRA will continue to allow manufacturers to supply medicines in legacy EU packaging until 31 December 2024. This extends the previous 31 December 2023 deadline, which required medicines for GB to be presented in GB compliant packaging, by one year.
- Before implementing any new artwork changes, companies must notify the MHRA and have until 31 December 2024 to do so.
- From 1 January 2025, all Parallel Imports (PLPIs) will be authorised to be marketed in the UK. Separate guidance will be published on the licensing process that will cover the transition of licences in the coming weeks.
- From 1 January 2025, joint EU/UK packs can no longer enter the supply chain.
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