Guidance

UK Parallel Import Licences Following Agreement of the Windsor Framework

Published 5 April 2024

Applies to England, Scotland and Wales

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 PDNs are no longer valid in Great Britain (England, Scotland, Wales).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) and any 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.

1. 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.

2. ‘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 and best practice guidance.

There are no other font or style requirements other than stated above.

3. 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.

4. 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 correctly and cannot re-enter the EU supply chain. From 1 January 2025, any 2D barcode encoding an alphanumeric character sequence (as referred to in EU Regulation 2016/161) that has been uploaded to the European repositories system should be fully removed or covered.  Packs must comply with the requirements in section 6 of the Windsor Framework guidance on labelling and packaging requirements.

A separate variation is not required to remove the FMD label details from PLPI artwork.

5. Supply of existing stock in existing packs

Any stock in existing packaging already placed on the market in Northern Ireland and GB (in accordance with the relevant rules in Northern Ireland or GB (i.e. released by a Qualified Person (QP) up until that date) can continue to be supplied to patients in the relevant territory until the date of their expiry.

All new packs placed on the UK market on or after 1 January 2025 must display ‘UK Only’ label.

6. Early release to market

Ahead of the 1 January 2025 commencement date, updates to labelling and packaging can start to be made from the date of publication of this guidance and will be permitted for all PLPI licences:

6.1 PLPIs with a current UK territory

The ‘UK Only’ label can be applied to packs before 1 January 2025, however, these packs will need to remain compliant with EU FMD requirements until this date.  Packs can be released onto the UK market with a ‘UK Only’ label once the MHRA has been notified or artwork approved.

6.2 PLPIs with a current GB territory

The ‘UK Only’ label can be applied to packs and released to the GB market before 1 January 2025, upon either the MHRA acknowledging receipt of the notification or approval of artwork.

6.3 New applications for PLPI licences

All new PLPI licence submissions from the date of issue of this guidance may include ‘UK Only’ on packs either indelibly or via stickering.  Packs may be released immediately after grant onto the appropriate market (GB before 1 January 2025 or UK, as licenced).  

Products marketed in GB only must continue to use the ‘PLGB’ prefix on labels and leaflets until 31 December 2024.

7. Summary table of labelling & packaging requirements

7.1 Current PLPI Licences

Current licence (before 1 Jan 2025)	Current market (before 1 Jan 2025)	Do FMD requirements currently apply?	Earliest submission date for ‘UK Only’ inclusion 1	Earliest date that packs with ‘UK Only’ label can be released to current market	Date of disapplication of FMD
PLPI (PL)	UK	Yes	Immediately	Immediately on receiving acknowledgement from MHRA of notification or approval of artwork	From 1 Jan 2025
PLPI (GB) (non-CAP)	GB	No	Immediately	Immediately on receiving acknowledgement from MHRA of notification or approval of artwork	N/A
PLPI (GB) (CAP)	GB	No	Immediately	Immediately on receiving acknowledgement from MHRA of notification or approval of artwork	N/A

^{‘UK Only’ inclusion either by notification of stickering or update to labelling artwork}.

7.2 New applications for PLPI licences

New PLPI licence (before 1 Jan 2025)	Current market (before 1 Jan 2025)	Do FMD requirements currently apply?	Earliest submission date for ‘UK Only’ label in initial submission1	Earliest date that packs with ‘UK Only’ label can be released to current market	Date of disapplication of FMD
PLPI (PL)	UK	Yes	Immediately	Immediately on grant of licence	From 1 Jan 2025
PLPI (GB) (non CAP)	GB	No	Immediately	Immediately on grant of licence	N/A
PLPI (GB) (CAP)	GB	No	Immediately	Immediately on grant of licence	N/A

^{‘UK Only’ can be applied by stickering or indelibly on artwork.}

7.3 Summary table of future licensing regime for parallel imports

	Current position	From 1 Jan 2025	Action required from Parallel Imports (PLPI) licence holders
New PLPI licence for non-CAP product authorisations	UK-wide authorisation (PL) or option to apply for GB authorisation (PLGB)	UK-wide authorisation only (PL)	For products entering the market from 1 Jan 2025, PLPI licence holders may apply for PL licences only. Must comply with labelling and packaging requirements.
New PLPI licence for CAP product authorisations	GB authorisation only (PLGB)	UK-wide authorisation only (PL)	For products entering the market from 1 Jan 2025, PLPI licence holders may apply for PL licences only. Must comply with labelling and packaging requirements.

8. Further information

Please send any general enquires in relation to parallel imports to: PLPI@mhra.gov.uk.

See further guidance on how to apply for a parallel import licence.

9. References

1. Subject to the UK providing written guarantees to the European Commission as provided for in Article 8 of EU Regulation 2023/1182 and following the entry into force and application procedure provided for in Article 14.
2. Use of stickering is subject to the requirements as set out in Article 5 of EU Regulation 2023/1182