Medicines Healthcare Products Regulatory Agency
Details
Parallel Distribution Notices (PDNs) are notice letters which parallel distributors must obtain from the European Medicines Agency before placing a centrally authorised product on the market.PDNs are no longer valid in Great Britain (England, Scotland, Wales). These were replaced by Parallel Import Licences (PLPIs) through the PDN to PLPI conversion process, which allow the products to be marketed in Great Britain (GB) only. PDNs currently remain valid in Northern Ireland.
From the implementation of the Windsor Framework on 1 January 20251, the MHRA will license all medicines across the whole of the UK and PDNs will no longer be valid in Northern Ireland. This means that:
- All Parallel Imports (including Centrally Authorised Products) will be authorised to be marketed across the whole of the UK.
- All Parallel Imports will need a valid PLPI licence.
- All PLPIs with a current territorial limitation of GB will be converted to UK-wide authorisation automatically. This includes:all previous Parallel Distributed Notices (PDNs) that were converted to UK Parallel Import Licences (PLPIs) andany other PLPI licences that have a current GB territorial limitation.*A variation will not be required to change the territory from GB to UK-wide.
PLGB licence numbers and prefixes
All PLPI licences will continue to have the prefix PLPI and the licence number will not change. This means that:
- Any labels or leaflets containing the prefix PLGB must be changed to the prefix PL.*Any PLPI packs Qualified Person (QP) certified after 1 January 2025 must have the prefix PL on the packaging materials.
- PLPI licence holders must amend their packaging materials to reflect this and will not be required to submit a variation.
- Amendments may be done in-house, as and when companies QP certify stock.
UK Only label requirements
The guidance on the labelling and packaging of medicinal products following agreement of the Windsor Framework sets out that UK licensed medicines must be labelled as UK Only on their packaging to preclude onward movement of medicines back into any part of the European Union (EU), while ensuring medicines use the same packaging and labelling across the UK.
All new packs placed on the UK market on or after 1 January 2025 must display UK Only label. This includes PLPI licences with a current UK territory.
When using the UK Only statement on packaging, the following will apply:
- UK Only may be presented anywhere on the outer packaging only of the medicine.
- The text must be conspicuous and clearly legible, at least 7-point font and in line with Article 5 of EU Regulation 2023/1182, current MHRA expectations andbest practice guidance.
There are no other font or style requirements other than stated above.
Application of UK Only statement
The UK Only statement may be applied to existing products at an appropriate regulatory opportunity where the label documentation is updated and any new applications from the date of publication of this guidance. All new packs placed on the UK market on or after 1 January 2025 must display UK Only label.
PLPI licence holders may apply the UK Only statement by either stickering or indelibly (i.e. printing directly on the packaging)2.
PLPI licence holders must either submit a notification document for stickering or have approved artwork with UK Only on the labelling for all PLPI licences, before 1 January 2025.
3.1. Stickering
A UK Only statement may be applied via a sticker, with the use of permanent adhesive.
The sticker must be attached to the packaging of the medicinal product in a conspicuous place in such a way that it is easily visible, clearly legible, and indelible. It must not in any way be hidden, obscured, detracted from, or interrupted by any other written or pictorial matter or any other intervening material. The sticker must not cover any statutory text presented on the packs (e.g. batch number and expiry date) and should only be placed in a blank space on the carton.
This may be done as a Tell and Do process. Companies should submit the completed notification document as a PDF file to the MHRA Parallel Import Unit at: PLPI.Admin@mhra.gov.uk, confirming the licence numbers where a UK Only sticker will be applied.
There is no cost for informing the MHRA of stickering and a separate variation for each licence will not be required. The Tell and Do notification process is open to all parallel import companies. Packs may be QP certified for release to market upon the MHRA acknowledging receipt of notification. The stickering must be completed by the site named on the marketing authorisation prior to QP certification. PLPI licence holders should include the positioning of the sticker at the next regulatory opportunity of updating the label documentation (including any pharmaceutical variation affecting the labels).
3.2 Printing directly on the packaging
If there is not sufficient blank space to apply the sticker and/or PLPI licence holders wish to include the UK Only statement indelibly on their packaging, they may include this at any regulatory opportunity of updating the label documentation (including any pharmaceutical variation affecting the labels). A separate paid variation is not required. Packs may be QP certified for market immediately after approval of the artwork. Amendments to approved artwork cannot be made under the Tell and Do notification scheme and must be approved by the MHRA.
Variation collections (i.e. bulk submissions) will not be permitted to update the artwork.
Disapplication of FMD safety features and encoding of pack information under UK law
From 1 January 2025, the EU Falsified Medicines Directive (FMD) will no longer apply in Northern Ireland. EU FMD safety features will therefore not apply to parallel import licences. PLPI licence holders must still ensure packs are decommissioned c