In recent weeks, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published further guidance relating to the implementation of the Windsor Framework. From 1 January 2025, changes due to the Windsor Framework for the licensing, labelling and wholesale dealing of human medicinal products in the UK will become effective. The new measures require, amongst other things: (i) all human 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”) requirements to UK-wide packs.
Following the MHRA’s initial publication of guidance focusing on the changes to labelling and packaging (please see our blog post here), the Agency has now issued guidance relating to wholesalers and manufacturers (“Wholesaler and Manufacturer Guidance), licensing (“Licensing Guidance”) and advertising (“Advertising Guidance”).
We explore some of the key requirements and recommendations for supply chains and promotional material arising from this new guidance below.
A. “UK only” Label and QP Certification
From 1 January 2025, a Qualified Person (“QP”) can only certify product intended for the UK market that bears the “UK only” designation on its packaging. This can be applied to the outer packaging and, until 30 June 2025, stickering is permissible (i.e., the application of a sticker to a medicine’s packaging). After this date, companies will be required to print the “UK only” label directly onto packaging. If products are imported without a “UK only” label, importers may perform the stickering in the UK prior to QP certification and release to the market.
To avoid disruption to supply chains and possible product shortages, marketing authorization holders (“MAHs”) may begin making the required labelling changes to Great Britain (“GB”) licensed products and release them to the GB market prior to 1 January 2025. Any GB-licensed medicines bearing the “UK only” label which have been QP certified and released onto the market prior to midnight on 31 December 2024 will be valid for immediate supply to the Northern Ireland (“NI”) market from 1 January 2025.
By contrast, QP-certified packs not bearing the “UK only” label cannot be supplied into NI unless featured on the Northern Ireland MHRA Approved Route (“NIMAR”) list. The Wholesaler and Manufacturer Guidance confirms that the NIMAR list will remain in force to continue to facilitate the supply of packs into NI in circumstances where no alternative authorized medicines are available.
B. Joint EU/UK packs already placed on the market
MAHs should also note that the derogations for medicinal products supplied to the Republic of Ireland and NI from EU Directives 2001/20/EC and 2001/83/EC will expire on 31 December 2024. From 1 January 2025, all medicines released to the Irish market must be compliant with EU pharmaceutical legislation.
Further, QPs should note that they will not be able to certify and release joint EU/UK packs into the UK supply chain from 1 January 2025. However, the Wholesaler and Manufacturer Guidance confirms that packs which are certified by a QP and released to the UK market in existing packaging up to and including 31 December 2024 may continue to be supplied until their expiry date.
C. UK-wide Disapplication of the EU Falsified Medicines Directive
Currently, the EU FMD still applies in NI. From 1 January 2025, the EU FMD will be disapplied UK-wide (GB and NI) and the UK repository established under this legislation will no longer be accessible. Features included on a medicine’s outer packaging for the purposes of compliance with the EU FMD, including an EU FMD-compliant 2D serialization barcode, must be removed or fully covered on any “UK only” pack.
D. Export Activity to Non-EU Countries
The MHRA stresses that medicine packs bearing the “UK only” designation may still be exported to other countries and territories outside the EU from 1 January 2025, provided that the export of those medicines complies with local legal requirements or provisions and the medicines do not feature on the Department of Health and Social Care’s export ban list.
E. Activities Performed in Northern Ireland
The MHRA will remain the national competent authority for whole of the UK (including NI) from 1 January 2025.
The Wholesaler and Manufacturer Guidance also confirms that NI-based QPs named on a NI Good Manufacturing Practice (“GMP”) authorization may continue to certify batches for both UK and EU markets where the site of batch release is located within NI. However, NI-based companies using sites in GB for batch release may only supply those goods to the UK. Companies located in GB may use any MHRA-approved NI site to facilitate the supply of medicines to the UK, where they are not subject to any other restrictions.
F. EEA Storage Facilities
In addition, the MHRA states that it will no longer be possible to use storage facilities based in the European Economic Area (“EEA”) for “UK only” medicines packs from 1 January 2025, where such packs have already been “physically placed” on the market in the UK. However, where a QP has certified a “UK only” batch in the EU and this is held at a manufacturing site or pre-wholesaler, the batch may remain stored there until supplied into the UK.
G. Responsible Persons for Import
The Wholesaler and Manufacturer Guidance also sets out the following requirements in relation to a Responsible Person for Import (“RPi”). Post-Brexit, it has been possible for the holders of wholesale distribution authorizations (“WDAs”) to import product from the EEA in reliance on the EEA QP’s batch release certification. Under the new framework:
- When importing goods under the RPi process, wholesalers must ensure that packs QP-certified after midnight on 31 December 2024 are compliant with the conditions of MHRA guidance and bear the requisite “UK only” designation.
- Where a company intends to supply QP-certified non-compliant (i.e., non-“UK only” labelled, etc.) GB-licensed medicines into NI, wholesalers should refer to the NIMAR list to determine if a product can be supplied. If a non-compliant product is removed from the NIMAR list, remaining packs that are already on the NI market can remain in the supply chain until their expiry date.
The Guidance also confirms that:
- medicines with UK-wide marketing authorizations (“MAs”) released prior to 31 December 2024 may continue to be supplied across the UK until the expiry or dispensing of those medicines, whichever comes first, and do not require “UK only” labelling; and
- NI-only licensed products released prior to 31 December 2024 may similarly continue to be supplied in NI until the expiry or dispensing of those medicines, whichever comes first, and do not require “UK only” labelling.
The MHRA also requires wholesalers to remain vigilant as to the licence conditions of products they procure or supply. The Guidance suggests segregating products according to destination and putting safeguards in place to avoid the supply of non-compliant medicines to NI.
H. Promotional Material
The MHRA’s Advertising Guidance, published in November, addresses changes to the advertising and promotion of medicines in the UK from 1 January 2025.
1. UK-Wide Advertising
Given that the Windsor Framework will result in the majority of MAs for medicines in the UK being UK-wide, it will be permissible for MAHs to advertise these products throughout the UK. However, exceptional circumstances where a medicine is only licensed in part of the UK (e.g., GB or NI) could still arise. In such circumstances, the medicine may only be advertised in the part of the UK where it is licensed, and UK-wide advertising is prohibited. The Prescription Medicines Code of Practice Authority (“PMCPA”) – the self-regulatory body for pharmaceutical advertising in the UK – has issued guidance advising that where the licence is not UK-wide, companies should continue to make it clear as to which part of the UK the material relates. The PMCPA suggests that companies could satisfy this requirement by including language on materials such as “For NI health professionals only” or “For GB health professionals only.”
The MHRA also clarifies that MAHs cannot use the same advertisement across the UK and Europe where a product’s indications differ in the UK from that of other European territory(ies), given that such advertisements would not comply with the UK summary of product characteristics (“SmPC”).
2. Licence Numbers
From 1 January 2025, the EU licence number that was assigned to licences applicable in NI will no longer apply. The MHRA states that this number should therefore be phased out of UK advertising at the earliest opportunity, although the Agency does not expect this to take place by or on 1 January 2025. In place of the EU licence numbers, MAHs will need to ensure that their promotional material refers to the appropriate licence number(s) with the prefixes outlined below:
- UK-wide MA: a product licensed by the MHRA, across the whole of the UK (which may include MAs with a PL or PLGB prefix).
- NI MA (PLNI): a product licensed by the MHRA that covers NI only as the territorial application, with PLNI as the MA number prefix.
- GB MA (PLGB): a product licensed by the MHRA that covers GB only as the territorial application, with PLGB as the MA number prefix.
3. Prescribing Information
The MHRA advises that MAHs review, amend or clarify any references to territories in their products’ prescribing information that may cause confusion. For instance, prior to 1 January 2025, UK-wide advertisements may have specified that a product has a GB MA. Such a statement may need to be removed where this is changing to a UK-wide MA from 1 January 2025 to avoid confusion.
The PMCPA will provide a grace period for such changes from 1 January 2025 to 31 December 2025, during which time the PMCPA will not consider it a breach of the Code of Practice for the Pharmaceutical Industry (“ABPI Code”) if the MA number and/or MA holder’s name and address in respect of a medicine, as required in the prescribing information by Clause 12.2(vii) of the Code, is incorrect for NI. The PMCPA’s grace period is subject to the MAH satisfying the following criteria:
- the rest of the prescribing information is otherwise consistent with the SmPC in place from 1 January 2025;
- other changes to the prescribing information have not been needed (in which case the MA number and MA holder’s name and address should be updated at that point);
- the prescribing information has an MA number that was accurate as of 31 December 2024; and
- from 1 January 2025, the MA holder can still be contacted via the address given in the prescribing information.
If the MAH cannot meet these criteria, the PMCPA states that the MAH should withdraw/amend the promotional material promptly, and by 15 January 2025 at the latest.
Comment
The latest guidance from the MHRA provides substantial granularity as to the arrangements for the fast-approaching implementation of the Windsor Framework on 1 January 2025. MAHs should review this guidance carefully as early as possible to ensure they are well-prepared for the raft of changes taking effect at the start of next year.
Covington will continue to follow developments and provide further updates. If you would like to discuss the Windsor Framework and what it means for your supply chains, please contact our specialist UK and Irish life sciences regulatory lawyers: Grant Castle, Marie Doyle-Rossi and Dan Spivey.