Skip to main content
Guidance

Medicines: apply for a parallel import licence

How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.

From:
Medicines and Healthcare products Regulatory Agency
Published:
21 January 2015
Last updated:
26 August 2026 — See all updates

The UK parallel import licensing scheme lets a medicine authorised in European Economic Area (EEA) Member State be marketed in the UK, as long as the imported product has no therapeutic difference from the cross-referenced UK product.

If you want to parallel import a product you must make sure that:

To assemble and repackage the product you will also need to have an manufacturer’s licence covering product assembly.

If your product is controlled by the Misuse of Drugs Act you will need an import licence from the Home Office.

If you are granted a licence, you will still need to comply with any other statutory provisions or any private civil rights of third parties.

You must be entitled to use the name of your product and it must not infringe on trademarks. MHRA does not consider trademark infringements when granting parallel import (PLPI) licences.

Parallel import licence application categories

PLPI applications fall into 3 categories.

Parallel import (simple)

A simple parallel import licence can be granted when:

  • the holder of the UK marketing authorisation and the holder of the marketing authorisation for the product to be imported from a Member State are held by companies in the same group; or
  • a licensing agreement exists between the market authorisation holders

This is the traditional ‘common origin’ criterion for parallel import licences.

Parallel import (complex)

This category applies when the UK and imported products do not share a common origin (as defined above) and:

  • the imported product contains a new excipient
  • the imported product contains an active ingredient made by a different route from the UK product
  • the imported product is a controlled release preparation
  • the imported product is a sterile product which is sterilised in a different way from the UK product
  • the imported product is a sterile product in which the container is made from a different material to the container of the UK product
  • the imported product is an influenza vaccine
  • the product is a metered dose inhaler
  • the product is a powder for inhalation

Parallel import (standard)

This category applies when the UK and imported products do not share a common origin (as defined above) but the application is not considered to be complex.

Parallel Imports following the agreement of the Windsor Framework

From the implementation of the Windsor Framework on 1 January 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) will license all medicines across the whole of the UK and Parallel Distribution Notices (PDNs) will no longer be valid in Northern Ireland.

The Windsor Framework sets out the long-term arrangements for the supply of medicines into Northern Ireland. It will ensure that medicines can be approved and licensed on a UK-wide basis by the MHRA and provides for the disapplication of European Union (EU) Falsified Medicines Directive (FMD) requirements for medicines marketed and supplied in Northern Ireland.

For further information on the Windsor Framework, please see the guidance on UK Parallel Import Licences following agreement of the Windsor Framework.

Falsified Medicines Directive: Requirements for Parallel Imports

From the implementation of the Windsor Framework on 1 January 2025, EU FMD safety features will not apply to parallel import licences.  PLPI licence holders must still ensure packs are decommissioned correctly and cannot re-enter the supply chain. For further details, please read our guidance on FMD requirements for parallel imports.

Submit your parallel import licence application

You must submit the application through the MHRA portal. The electronic application form is available from the Portal.

Any submission that does not meet the submission requirements will be invalidated and rejected. You will be told the reasons for the invalidation by email. Once an invalid application has been rejected, the whole application must be re-submitted.

Documents for submission

To make a PLPI submission you need to complete the electronic application form, including details of the appropriate UK cross-reference product which the application is based on.

All sections of the form must be accurately completed. If a separate company functions list is provided (recommended), sections 12, 13, 14 and 15 of the application form do not need to be completed.

In addition to the completed application form, you will need to submit the following documentation at a minimum. 

  1. Cover letter
  2. Mock-up artwork of all proposed labelling artwork
  3. Mock-up artwork of the patient information leaflet and any healthcare professionals’ leaflets or instructions for use in English language
  4. User test for readability report
  5. Your latest approved company functions list stating assembler, batch release, storage, importer and distributor sites

All documents should be submitted in PDF format with one PDF file for each document. PDF files must be readable, and it must be possible to ‘cut and paste’ data from them.

Sample scan submission

You must submit a complete scan of the imported sample pack to PLPI.Samples@mhra.gov.uk .

The scan must clearly show:

  • The full and exact contents of the imported pack.
  • The complete patient information leaflet (PIL).
  • Any tablet or capsule markings.
  • Any braille included on the packaging.

All images must be saved in .jpg format and submitted as a single .zip file together with a completed sample scan cover sheet Samples cover sheet.docx.

The total size of the zipped submission must not exceed 10 MB.

For detailed guidance on preparing and submitting sample scans, contact PLPI@mhra.gov.uk .

Packaging materials

All labels, patient information leaflets (PILs) and packaging for parallel import medicines must comply with current guidance. For general requirements, see the guidance on submitting labels, patient information leaflets (PILs) and packaging  submitting applications for labels, patient information leaflets (PILs) and packaging .  Additional requirements that apply specifically to parallel import medicines are set out below. If you require further information or advice, email PLPI@mhra.gov.uk .

Labelling Artwork Submission

You must submit all labelling artwork as a single PDF file. A completed label summary sheet must be included with the submission.

Labelling artwork must:

  • Show the dimensions of all overlabelling.
  • Demonstrate that the primary packaging remains intact.
  • Include appropriate overlabelling for all packaging components.
  • Be designed to support patient safety and ensure that any original features necessary for the safe and effective use of the medicine are not obscured.
  • Include all safety information contained in the equivalent cross-referenced UK product labelling.
  • List all excipients on the labelling for parenteral, ophthalmic and topical medicinal products.

All parallel imported medicinal products, except those intended to be administered solely by healthcare professionals, must include braille on the packaging.

For detailed guidance on labelling requirements, contact PLPI@mhra.gov.uk.

Patient Information Leaflets (PILs)

The Patient Information Leaflet (PIL) for a parallel import product should follow the wording of the PIL for the cross-referenced UK product as closely as possible. This helps ensure that patients receive information that is consistent with that provided for the equivalent UK-authorised medicine.

Any differences should be limited to information that is specific to the parallel import product, including:

  • The name of the imported product, where applicable.
  • The PLPI licence number.
  • The name and contact details of the PLPI licence holder.
  • Pharmaceutical company particulars relating to the imported product.
  • Any other information necessary to identify the imported product and the PLPI licence holder.

The PIL should not introduce additional information, omit required information, or alter the approved medical content of the cross-referenced UK product leaflet, unless this is necessary to accurately reflect the imported product.

The leaflet must be presented in a clear and legible format and comply with current requirements for patient information leaflets. Applicants should ensure that the PIL remains consistent with the most up-to-date approved version of the cross-referenced UK product leaflet.

User testing for readability of patient information leaflets

Patient information leaflets (PILs) for parallel import products must demonstrate user testing for readability to comply with legal requirements. This must demonstrate that users can find and understand the key information needed for the safe and effective use of the medicine.

For parallel import products, applicants may demonstrate compliance with the readability requirements in one of the following ways:

  1. Full user test - a complete readability test conducted with appropriate target patient groups.
  2. Bridging studies - evidence demonstrating that the proposed PIL is sufficiently similar in style and format to a leaflet that has already been successfully tested.
  3. Compliance to the UK PIL – evidence demonstrating that the proposed PIL is sufficiently similar in style and format to the UK-referenced PIL.

See guidance on user testing information leaflets for parallel imported licences for detailed requirements (PDF, 276 KB, 10 pages)

Company Functions involved in parallel importing

The applicant must inform MHRA of which companies will be carrying out each function associated with import of a product by either putting them on the application form or attaching a company functions list (preferred) covering all the sites with their relevant manufacturer/importer or wholesale dealer licence numbers.

  • Wholesale Dealers Licence WDA(H) – covering import, storage and sale of products. A wholesale dealer in UK may import Qualified Person certified medicines from EEA if certain checks are made by the ‘Responsible Person (import). See the current guidance on RPi requirements for parallel imports.
  • Manufacturer/import/assembly (MIA) Licence – covering manufacture/ assembly of Parallel Import products and import of licenced medicinal products. The MIA must be approved for secondary packaging of parallel imported medicines.  For sites in the UK, the repackaging site must be approved for parallel imports.  For all function sites outside the UK and within the EEA member states, the MHRA need proof that the site holds the relevant licence from the regulatory authority in that country.

Suppliers’ list declaration

Submission of a complete suppliers list is not mandatory provided the following is provided electronically. A statement stating including the wording below, on letter-headed paper, should be signed and emailed as a PDF to plpi@mhra.gov.uk :

I confirm that (insert company name) (MHRA company number) (insert company number) will only obtain parallel import products from suppliers which hold an appropriate authorisation (wholesaler or manufacturer licence).

I confirm that the validity of this authorisation has been confirmed by us.

I confirm that the suppliers’ details will be recorded in the details of each batch of product imported.

Signed: Director

Name:

Date:

Assessment process - One ‘RFI’ Rule

If there is information missing from your submission or changes need to be made, the One ‘RFI’ Rule policy sets out that the MHRA will only issue one Request for Further Information (RFI) for all applications.  The MHRA will correspond with the applicant once, to explain the information which is missing or the changes which are required. The applicant will be given one opportunity to address the outstanding issues.  If after this the applicant has not sent the information or made the required changes within 30 calendar days, the MHRA will refuse the application. 

This policy is applicable to both initial and variation applications.

In some cases, the MHRA will make an exception. This will be decided on a case-by-case basis and only in exceptional circumstances.

This policy aims to expedite assessment times with emphasis on the parallel import industry to eliminate errors and submit high quality applications.

Make a variation to your parallel import licence

Under the Human Medicines Regulations 2012, a parallel import licence can be granted where the reference product has a UK marketing authorisation. 

You must keep your licence up to date. If the holder of the UK marketing authorisation for the reference product makes changes to their marketing authorisation, you may need to vary your parallel import licence.

You must:

  • keep informed of any changes to the marketing authorisation for the reference product
  • submit a variation to your parallel import licence where necessary to ensure it matches the updated marketing authorisation
  • submit a variation if there are changes to the arrangements for repackaging the imported product

You can find the list of PLPI variation codes, including submission requirements and fees, here.

Where relevant, you must also submit a complete sample scan of the imported product.

You must submit variation applications through the MHRA portal. 

If you are submitting more than 50 variation applications at the same time, you must tell MHRA at least 3 working days before submission by emailing PLPI_submissions@mhra.gov.uk.

Failure to vary the licence details, as required will be treated as a breach of the licence terms.

Tell and Do (TaD) variations

TaD is a procedure which allows you to submit a variation for a change to the imported product and/or your parallel import licence particulars and then continue repackaging and distributing the product while the variation is assessed by the MHRA.

The TaD procedure for parallel imports is now based on the type of variation and safety implication, rather than the licensing route of the imported and UK product licence.

The following variation codes may only be submitted as TaD variations:

• Code 57 – change in the cross-referred UK licence (all PLPI licences)

• Code 51 – change in the EUMA marketing authorisation holder details (*selected)

• Code 52 – change in the manufacturer name (*selected)

• Code 58 – change in the manufacturer address (*selected).

Note:

  • All manufacturer and EU Marketing Authorisation Holder changes for Centrally Authorised Products (CAPs) licensed by the EMA, may be regarded as Tell and Do variations. CAPs will have an ECMA number in the form EU/XX/XXX/XXX.
  • *Selected non-CAP imported products may be eligible for TaD variations (refer to the table for further detailed guidance).

All companies are eligible to utilise the Tell and Do Process.

Process

  1. A variation must be submitted to the MHRA incorporating any changes to artwork, as necessary.
  2. Companies must include a TaD Cover sheet for PLPI Companies (MS Word Document, 48 KB) with the submission documents.
  3. Sample scans are only required to be submitted for non-CAP EU MAH and manufacturer changes. Sample scans must be sent to PLPI.Samples@mhra.gov.uk .
  4. Multiple variations for a single licence may be submitted as TaD variations, but only if the requirements as listed in the table below are met. If a licence requires other variation codes (excluding Code 64 – Patient Information Leaflet update) to be submitted due to concurrent changes, TaD is not permitted.
  5. Collections are not permitted for TaD variations.
  6. No Requests for Further Information (RFIs) will be permitted for variations submitted via the Tell and Do procedure. The application will be refused if incorrect.
  7. If the application is submitted incorrectly and does not meet the requirements as set out in points 1,2,3,4 and 5, the application will be refused.
  8. If a variation is refused the company must cease processing immediately and resubmit the variation as a non-TAD variation. No further stock may be released until the variation is approved.
  9. The relevant fees are applicable for TaD variations.
  10. Companies may continue processing stock using the new submitted documentation/updated artwork.
  11. Any amendments following the approval of the variation must be implemented immediately.
  12. Implementation of accurate Tell and Do variations will be verified on routine inspections.
  13. Company authorisation for use of Tell and Do variations may be rescinded if there are any breaches in MHRA requirements.

It is the responsibility of the licence holder to ensure the safety of their licensed products. If there are any doubts, use the default position of stop processing and confirm with the parallel import unit (PLPI@mhra.gov.uk ).

Post-licensing obligations

The normal requirements for reporting adverse reactions and defects apply to PLPI products.

If a PLPI product needs to be recalled the licence holder must arrange this. The records kept must be suitable for this.  The MHRA must be notified immediately stating the reason if a product is withdrawn for safety reasons.

To notify MHRA call 020 3080 6574 or use the defective product form on the Yellow Card website

Renew your parallel import licence

A PLPI is granted for 5 years.

Updates to your licence cannot be made through a renewal.

Renewals must be submitted in the 3 months before the licence expires.

You should renew your PLPI licence using the MHRA Portal. Only the Renewal electronic application form should be submitted.

Inspections of parallel import companies

PLPI assessors may accompany inspectors on good manufacturing practice (GMP) inspections of PLPI companies to look particularly at regulatory compliance.

The inspection will:

  • check the implementation of leaflet safety updates
  • check leaflets to see if they are up to date, user tested and incorporated into packs within the correct timescale
  • check labels to ensure the correct label is being used and is affixed in the approved manner and that it contains the correct child warning
  • check Braille
  • check manufacturer details

Fees

Fees for PLPI applications and variations

Make a payment to MHRA

Contact

For portal issues email Portal.Manager@MHRA.gov.uk or call 020 3080 7100.

If you have a question about the validation of your submission or the progress of your application email RIS.NA@mhra.gov.uk.

For more general enquiries about PLPIs email MHRA Customer Services at MHRACustomerServices@mhra.gov.uk or call 020 3080 6000.

Updates to this page

Published 21 January 2015
Last updated 26 August 2026 Show all updates

  1. The Parallel Import application guidance has been updated to provide more detailed information on the submission process. The guidance now includes links to additional information on variation codes, as well as the cover sheets required for submitting applications.”

  2. TaD cover sheet for PLPI companies updated

  3. Updated text on Tell and Do (TaD) variations.

  4. Updated to reflect guidance on UK Parallel Import Licences Following Agreement of the Windsor Framework.

  5. Updated to reflect guidance on UK Parallel Import Licences Following Agreement of the Windsor Framework

  6. Updated MR-DC product list - applicable from 1 December 2023

  7. Updated MR-DC product list - applicable from 7 September 2023

  8. Updated the MR-DC list PDF

  9. Updated the MR-DC product list

  10. Updated MR-DC product list - 7 October 2022

  11. Updated MR-DC product list.

  12. MR-DC product list updated.

  13. Updated Mutual Recognition/Decentralised product list

  14. Updated following the end of the transition period. Primarily new information on how to submit your parallel import licence application.

  15. Updated parallel import MR-DC list

  16. Updated MR-DC product list PDF

  17. Updated MR-DC product list

  18. updated the MR-DC product list to 10 December 2019 version

  19. Updated the guidance on user testing information leaflets for parallel imported licences

  20. Updated MR-DC product list to dated 31/05/2019 version

  21. Updated the current MR-DC product list

  22. MR-DC product list updated.

  23. New MR-DC Product List added to the page.

  24. Updated the MR-DC product list.

  25. Updated MR/DC list

  26. MR-DC product list updated.

  27. Updated MR-DC product list added - 24/08/2016

  28. Updated product list

  29. Updated Parallel Import MR-DC List.

  30. Updated Parallel Import MR-DC List.

  31. Updated the current MR-DC product list for parallel import licence.

  32. Updated parallel import MR-DC list.

  33. Updated parallel import list added

  34. Updated MR-DC product list

  35. MR-DC product list has been updated - 07 April 2015

  36. The most recent MR-DC list has been added to the page.

  37. First published.

Sign up for emails or print this page

Contents

Related content