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.
“UK Only” Label Requirements
The MHRA Guidance specifies the following with respect to the “UK only” label:
- “UK only” must be conspicuous and clearly legible on a medicine’s outer packaging.
- The text must be: (i) at least 7-point font; (ii) in accordance with Article 5 of Regulation (EU) 2023/1182; and (iii) in alignment with current MHRA expectations and best practice advice. There are no other font or style requirements.
- There is no prescribed location for the label on the outer packaging.
The MHRA Guidance explains that stickering (i.e., the application of a sticker to a medicine’s packaging) is permissible in respect of the “UK only” label until 30 June 2025. After this date, companies will be required to print the “UK only” label directly onto packaging.
The MHRA also provides specific stickering guidance, including that the stickering:
- must be done prior to the certification of a medicine’s packaging by a Qualified Person;
- must be completed by the site named on the product’s marketing authorization; and
- must not cover any other statutory text on the pack.
Marketing authorization holders (“MAHs”) intending to sticker for the 6 months’ permissible will have to provide updated mock-ups of their products’ outer packaging to the MHRA. Such mock-ups must show where the sticker will be placed. There is no requirement to submit a further updated mock-up to the MHRA when the “UK only” label is subsequently printed directly on the pack.
Disapplication of the EU Falsified Medicines Directive
The latest Guidance confirms that the EU FMD will not apply in Northern Ireland (“NI”) from 1 January 2025. Features included on a medicine’s outer packaging for the purposes of compliance with the EU FMD can be removed.
However, “UK only” packs will need to remain compliant with all existing safety requirements under UK law, such as the placement of the expiry date and batch number, whilst the MHRA continues to encourage the inclusion of anti-tampering features on packaging.
In addition, MAHs may apply the following features to a medicine’s packaging (although these are not compulsory):
- a 2D barcode encoding data about the product, including its expiry date, batch number, Global Trade Item Number, and serial number if applicable; and
- a serial number of any format.
Notably, the presence of a 2D serialization barcode for the purposes of the EU FMD is prohibited. Such a barcode must be removed or fully covered on any “UK only” medicinal pack.
As of 29 September 2023, MAHs may begin making the labelling changes required under the Windsor Framework for UK-wide and Great Britain (“GB”) licensed products.
However, while the packs of UK-wide licensed products (i.e., those to be marketed in both GB and NI) can be updated to display the “UK only” label before 1 January 2025, they must also remain complaint with the requirements of the EU FMD until this date (as this continues to apply in NI until 1 January 2025).
Medicines with GB product licences can also be updated early, but packs bearing the “UK only” label cannot be released into the supply chain in either GB or NI before 1 January 2025.
If MAHs implement the packaging changes prior to 1 January 2025, they must notify the MHRA of any artwork changes. The MHRA Guidance describes two methods by which MAHs may do so:
- Alongside another variation application: Firstly, MAHs can submit artwork changes alongside another application. The MHRA guidance states that this can be “any available regulatory opportunity,” except Type 1A variations (i.e., those which have little or no impact on the quality, safety or efficacy of the product). No additional fee will be required for such an artwork change, but the cover letter and form submitted with the variation application must make reference to the fact that the MAH has updated the labelling in accordance with the Windsor Framework requirements. Under this route, MAHs must await MHRA sign-off on the artwork changes before implementing them.
- Self-certification: Alternatively, MAHs can self-certify by submitting a separate notification specifically for the artwork change through the MHRA’s regulatory management system. With this route, MAHs need not wait for MHRA sign-off before implementing the proposed changes (provided these align with the relevant guidance). The usual implementation timeline of six months will not apply to such self-certified changes, so MAHs can implement the updated packs any time before 1 January 2025. The usual fees for self-certification will apply in these instances.
Where MAHs wish to submit a number of update notifications in bulk, the usual guidance on bulk submissions applies to both routes (with a limit of 25 licences per bulk application).
If more than one set of labelling is approved for a particular product (e.g., because a product is marketed under more than one name), the MHRA Guidance states that all labelling components must be updated through a single submission.
If the only change to a product’s packaging is the addition of the “UK only” label, the MAH is not required to submit a clean mock-up of the packaging to the MHRA. An annotated mock-up of the product’s packaging showing where the “UK only” text will be located is permissible. The Guidance suggests that MAHs should submit a clean mock-up at a subsequent regulatory opportunity where the label is being updated.
For ongoing marketing authorization applications, labelling mock-ups including the “UK only” text can be approved as part of the licensing procedure.
Parallel Import Packs
The MHRA Guidance sets out that all Parallel Imports (“PLPIs”) will be authorized for marketing in the UK from 1 January 2025 and those PLPIs currently limited to GB will be converted to UK-wide. PLPI companies should therefore not include “GB” on the packaging materials of products entering the UK supply chain from 1 January 2025.
Notably, PLPIs will not require a “UK only” label, nor will they need to comply with the EU FMD.
The MHRA is considering preparing further specific guidance on PLPIs.
Joint EU/UK Packs
Of particular note to companies marketing products throughout the EU and UK is the confirmation that joint EU/UK medicines packs will no longer be permitted to enter the supply chain from 1 January 2025.
MAHs are required to remove information relevant to other jurisdictions from “UK only” labelled packs. The MHRA also states that both of these changes should be made within the same submission.
However, the Guidance confirms that packs already released to the UK market in existing packaging prior to 1 January 2025 can remain in the supply chain until their expiry date.
GB Product Licences
The territorial extent of existing GB-only licences will be converted to UK-wide from 1 January 2025. However, the packs of GB-only licensed must continue to present the GB Product Licence number on the pack in addition to the “UK only” label.
This latest MHRA Guidance offers significantly more detail as to how, where and when the “UK only” labelling requirements under the Windsor Framework can be implemented. However, the timing and methods (within the parameters set out above) with which MAHs will implement the required changes remains to be seen.
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 and Marie Doyle-Rossi.