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Referring to information from EMVO, it was announced that the UKNI National system will be disconnected as of 1 January 2025. Therefore, OBPs will not be able to upload GB single-market packs after this date.
After 31 December 2024, the EU Hub will send an error message to inform the OBP that the GB single-market packs are not possible.
For a PPD (“GB” only) request, the EU Hub will respond with a ”#A16 – Data Validation error”, as well as with the addition ”#A22 – Market not found”.
This change will affect only products that are intended for the UK market.
Table of Contents
Summary of the Guidance | Labelling and packaging of medicinal products for human use following the agreement of the Windsor
Following the agreement of the Windsor Framework, these measures will commence on 1 January 2025:
- All new medicines and medicines in Northern Ireland that currently fall under the scope of the EU Central Authorization Procedure will be authorized by the MHRA for the UK market.
- These products will only be able to be sold in the UK and will not be available on the market in Ireland or elsewhere in the EU, other than available in the EU as ‘specials’ subject to EU rules and conditions.
- Packaging for all products for the UK market must carry a clearly legible ‘UK Only’ label.
‘UK Only’ label requirements
To enable medicines to use the same packaging and labelling across the UK, packaging for all UK medicinal products (Prescription Only Medicine and Pharmacy and General Sales List) must carry a clearly legible ‘UK Only’ label to be placed on the UK market.
The label may be presented anywhere on the outer packaging of the medicine.
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.
From 1 January 2025, joint EU/UK packs can no longer be released to the UK supply chain. A joint pack is one that is shared with another EU country or countries that present administrative details for both the UK and the other markets sharing the pack. Information relevant to other markets will need to be removed from the outer cartons for these packs when the ‘UK Only’ statement is added, and these changes should be made within the same submission. Packs already released to the market may, however, continue to be supplied until their expiry date.
The ‘UK Only’ statement can be applied via a sticker for a limited time period of 6 months, to 30 June 2025. After this date, ‘UK Only’ must be printed directly onto the packaging. Stickering will not be accepted after this date.
Disapplication of FMD safety features and encoding of pack information under UK law
All existing safety requirements under UK law, for instance on the placement of the expiry date and batch number and other packaging requirements, remain unchanged. In addition, under UK law, MA holders may choose to apply the following features on UK packaging, although this is not compulsory:
- a 2D barcode (Data Matrix), which may encode data including information about the specific medicinal product, the expiry date, batch number, Global Trade Item Number, and serial number if applicable; and
- a serial number of any format.
Traditional Herbal (THR) and Homeopathic (NR and HR) medicinal products
Packaging for all UK Homeopathic (NR) medicinal products should state ‘UK Only’ in line with the requirements stated in this guidance.
UK Herbal (THR) and Homeopathic (HR) medicinal products do not require a ‘UK Only’ label.
Parallel Imports (PLPI) Packs
From 1 January 2025, all Parallel Imports (PLPIs) will be authorized to be marketed in the UK. Any PLPIs with a current territorial limitation of ‘GB’ will be converted to UK-wide authorization.
All PLPIs must include ‘UK Only’ on their packaging from 1 January 2025. This includes PLPI licenses with a current UK territory.
Full guidance is available here
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