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:

the product is manufactured to good manufacturing practice (GMP) standards
you hold a wholesale dealer’s licence covering importing, storage and sale for each product
you hold the correct parallel import licence

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

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

If a PLPI product needs to be recalled you must arrange this. The records you keep must be suitable for this, and you must notify MHRA immediately and give the reason if you decide to withdraw a product.

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

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.

Labels, patient information leaflets and packaging

All labels, patient information leaflets (PILs) and packaging for parallel import medicines must comply with current guidance. Please see our guidance on submitting applications for labels, patient information leaflets (PILs) and packaging for more information, although not all is relevant for parallel imports. You should email MHRA Customer Services if you need more information.

All excipients in parenteral, ophthalmic and topical medicinal products must appear on the labelling.

For all other medicines, only excipients of known effect should be declared on the labelling.

European Medicine Agency guidelines give the wording for the patient information leaflet and packaging for these excipients. These warnings must be included even if they weren’t present on the UK packing and PIL.

User testing patient information leaflets

PILs must be user tested. PLPI companies can do their own user testing before the UK PIL has been user tested, as long as the tests show that users can find and understand the key messages in the leaflet.

However, if there are significant changes following user testing of the UK PIL, more testing may be necessary for the parallel import PIL to bring it in line with the UK version.

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

Company functions involved in parallel importing

Your application 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 list covering all the sites with their relevant manufacturer/importer or wholesale dealer licence numbers.

In order to obtain a parallel import licence, the following requirements must be met:

Parallel Import Licence Holder – must have a UK registered address.
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.
Acting as a Responsible Person (import) Manufacturer/import/assembly (MIA) Licence – covering manufacture/ assembly of Parallel Import products and import of licenced medicinal products.

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

You do not need to send a list of suppliers you will obtain the product from if you electronically submit the statement below. The statement, on letter-headed paper, should be signed and emailed as a PDF to plpi@mhra.gov.uk and include this wording:

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:

Submit your parallel import licence application

You should submit the application ( label summary template (MS Word Document, 59 KB)) through the MHRA portal. The 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.

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.

All leaflets should be submitted in a single, combined PDF document.

Documents for submission

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

The following documents should be sent to MHRA along with the application form:

proof of payment form – even if there is no fee for your application
completed renewal application form (MS Word Document, 26 KB) – this cover sheet is required when submitting any labels (whether initials or variations)
mock-ups of all proposed labelling and the patient information leaflet (PIL) in English
user testing report (if applicable)
the relevant complete sample with the foreign leaflet intact
an updated company functions list (assembler, batch release, storage, importer and distributor) (if applicable)

Make a payment to MHRA

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

You should submit a variation application to MHRA if changes are made to the product which you are importing. You can do this using the MHRA portal. You should also submit a scan of the full product.

When the patient information leaflet for the UK cross-referred product has been updated (excluding certain administrative changes), the PLPI patient information leaflet will also have to be varied.

If there are any changes to the arrangements for re-packaging the product you need to submit a variation. You may be charged a fee for the variation.

If you are submitting a variation and have discussed the fee with the MHRA PLPI assessment unit you should include confirmation of this agreement in your application. The MHRA PLPI unit can give you this in the form of an email or letter.

If you are submitting a high volume of submissions, (in excess of 50 variations at the same time) please inform MHRA at least 3 days before the submission by emailing PLPI_submissions@mhra.gov.uk.

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 new TaD procedure supersedes the previous parallel import procedure introduced in 2011 and the stop process lists (dated 18/11/2022), which are now both redundant and can no longer be used.

The following variation codes may only be submitted as TaD variations which are deemed as lower risk 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

A variation must be submitted to the MHRA incorporating any changes to artwork, as necessary.
Companies must include a TaD Cover sheet for PLPI Companies (MS Word Document, 48 KB) with the submission documents.
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.
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.
Collections are not permitted for TaD variations.
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.
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.
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.
The relevant fees are applicable for TaD variations.
Companies may continue processing stock using the new submitted documentation/updated artwork.
Any amendments following the approval of the variation must be implemented immediately.
Implementation of accurate Tell and Do variations will be verified on routine inspections.
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 ).

Renew your parallel import licence

A PLPI is granted for 5 years.

You can’t make any updates to your licence 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.

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 information about the progress of your application email ris.plpi@mhra.gov.uk or call 020 3080 7400.

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

Medicines: apply for a parallel import licence