The UK parallel import licensing scheme lets a medicine authorised in European Economic Area (EEA)(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)(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 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)(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)(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,Submit patientyour informationparallel leafletsimport andlicence packagingapplication

AllYou labels,must patientsubmit informationthe leafletsapplication through (PILs)the MHRA portal. andThe packagingelectronic forapplication parallelform importis medicinesavailable mustfrom complythe withPortal.

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Documents for submission

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

All excipientssections inof parenteral,the ophthalmicform andmust topicalbe medicinalaccurately productscompleted. mustIf appeara onseparate company functions list is provided (recommended), sections 12, 13, 14 and 15 of the labelling.application form do not need to be completed.

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1. Cover Medicineletter
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Sample andscan understandsubmission

You themust keysubmit messagesa incomplete scan of the leaflet.imported sample pack to PLPI.Samples@mhra.gov.uk .

However,The ifscan theremust areclearly significantshow:

• The changesfull followingand userexact testingcontents of the UKimported PIL,pack.
• The morecomplete testingpatient mayinformation beleaflet necessary(PIL).
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• Any PILbraille toincluded bringon itthe packaging.

All images must be saved in line.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 UKzipped version.submission must not exceed 10 MB.

SeeFor detailed guidance on userpreparing testingand submitting sample scans, contact PLPI@mhra.gov.uk .

Packaging materials

All labels, patient information leaflets (PILs) and packaging for parallel importedimport licences (PDF,medicines 276must KB,comply 10with pages)

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Labelling Artwork Submission

InYou ordermust tosubmit obtainall labelling artwork as a parallelsingle importPDF licence,file. theA followingcompleted requirementslabel summary sheet must be met:included with the submission.

Labelling artwork must:

• ParallelShow Importthe Licencedimensions Holderof –all mustoverlabelling.
• Demonstrate havethat athe UKprimary registeredpackaging address.remains intact.
• WholesaleInclude Dealersappropriate Licenceoverlabelling WDA(H)for –all coveringpackaging import,components.
• Be storagedesigned andto salesupport ofpatient products.safety Aand wholesaleensure dealerthat inany UKoriginal mayfeatures importnecessary Qualifiedfor Personthe certifiedsafe medicinesand fromeffective EEAuse ifof certainthe checksmedicine are madenot byobscured.
• Include theall ‘Responsiblesafety Personinformation (import).contained Seein the currentequivalent guidancecross-referenced onUK RPiproduct requirements for parallel imports.labelling.
• ActingList asall aexcipients Responsibleon Personthe (import)labelling Manufacturer/import/assemblyfor (MIA)parenteral, Licenceophthalmic – covering manufacture/ assembly of Parallel Import products and importtopical of licenced medicinal products.

ForAll allparallel functionimported sitesmedicinal outsideproducts, theexcept UKthose andintended withinto the EEA memberbe states, theadministered MHRA needsolely proofby thathealthcare theprofessionals, sitemust holdsinclude thebraille relevanton licencethe frompackaging.

For thedetailed regulatoryguidance authorityon inlabelling thatrequirements, country.contact PLPI@mhra.gov.uk.

Suppliers’Patient listInformation declarationLeaflets (PILs)

YouThe doPatient notInformation needLeaflet to(PIL) sendfor a listparallel ofimport suppliersproduct youshould willfollow obtainthe wording of the PIL for the cross-referenced UK product fromas ifclosely youas electronicallypossible. submitThis thehelps statementensure below.that Thepatients statement,receive oninformation letter-headedthat paper,is consistent with that provided for the equivalent UK-authorised medicine.

Any differences should be signedlimited andto emailedinformation asthat ais PDFspecific to plpi@mhra.gov.ukthe andparallel includeimport thisproduct, wording:including:

I

• The confirmname thatof (insertthe companyimported name)product, (MHRAwhere companyapplicable.
• The number)PLPI (insertlicence number.
• The name and contact details of the PLPI licence holder.
• Pharmaceutical company number)particulars willrelating onlyto obtainthe parallelimported importproduct.
• Any productsother frominformation suppliersnecessary whichto holdidentify anthe appropriateimported authorisationproduct (wholesalerand orthe manufacturerPLPI licence).
  licence holder.

IThe confirmPIL thatshould not introduce additional information, omit required information, or alter the validityapproved medical content of the cross-referenced UK product leaflet, unless this authorisationis hasnecessary beento confirmedaccurately byreflect us.the imported product.

IThe confirmleaflet must be presented in a clear and legible format and comply with current requirements for patient information leaflets. Applicants should ensure that the suppliers’PIL detailsremains willconsistent bewith recordedthe inmost theup-to-date detailsapproved version of eachthe batchcross-referenced ofUK product imported.leaflet.

Signed:

User Director

testing for readability of patient information leaflets

Name:

Date:

SubmitPatient yourinformation leaflets (PILs) for parallel import licenceproducts application

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DocumentsCompany forFunctions submissioninvolved in parallel importing

ToThe makeapplicant amust PLPIinform MHRA of submissionwhich youcompanies needwill tobe completecarrying theout applicationeach form,function includingassociated detailswith import of thea appropriateproduct UKby cross-referenceeither productputting whichthem on the application isform basedor on.

Theattaching followinga documentscompany shouldfunctions belist sent(preferred) tocovering MHRAall alongthe sites with thetheir applicationrelevant form:manufacturer/importer or wholesale dealer licence numbers.

• proofWholesale ofDealers paymentLicence formWDA(H) – evencovering ifimport, therestorage isand nosale feeof forproducts. yourA application
• completedwholesale 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 requestsRPi requirements for furtherparallel informationimports (PDF,.
• Manufacturer/import/assembly 4.06(MIA) MB,Licence 3– pages)covering –manufacture/ thisassembly coverof sheetParallel isImport requiredproducts whenand submittingimport anyof labelslicenced (whethermedicinal initialsproducts. orThe variations)
• mock-upsMIA 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 proposedfunction labellingsites outside the UK and within the EEA member states, the MHRA need proof that the patientsite informationholds leafletthe (PIL)relevant licence from the regulatory authority in Englishthat country.
• user

Suppliers’ testinglist reportdeclaration

Submission (ifof applicable)

a complete suppliers list is not mandatory provided the relevantfollowing completeis sampleprovided withelectronically. A statement stating including the foreignwording leafletbelow, intact

anon updatedletter-headed paper, should be signed and emailed as a PDF to plpi@mhra.gov.uk :

I confirm that (insert company functionsname) list(MHRA company (assembler,number) batch(insert release,company storage,number) importerwill andonly distributor)obtain (ifparallel applicable)

import products from suppliers which hold an appropriate authorisation (wholesaler or manufacturer licence).

MakeI aconfirm paymentthat tothe MHRAvalidity 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 thethe MHRA will MHRA will only issue one Request for Further Information (RFI) for all applications.  TheThe MHRA will 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, thethe MHRA will MHRA will refuse the application. 

This policy is applicable to both initial and variation applications.

In some cases, thecases, the MHRA will 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

YouUnder shouldthe submitHuman aMedicines variationRegulations application2012, toa MHRAparallel ifimport changeslicence arecan madebe togranted where the reference product whichhas youa areUK importing.marketing authorisation. 

You canmust dokeep thisyour usinglicence theup MHRAto portal.date. YouIf shouldthe alsoholder submit a scan of the fullUK product.

Whenmarketing theauthorisation patient information leaflet for the UKreference cross-referred product hasmakes beenchanges updatedto (excludingtheir certainmarketing administrativeauthorisation, changes),you themay PLPIneed patientto informationvary leafletyour willparallel alsoimport have to be varied.licence.

IfYou theremust:

• keep areinformed of any changes to the arrangementsmarketing authorisation for re-packaging the reference product
• submit youa needvariation to submityour aparallel variation. Youimport maylicence bewhere chargednecessary ato feeensure forit matches the variation.

  Ifupdated youmarketing areauthorisation

• submit submitting a variation andif havethere discussedare changes to the feearrangements withfor repackaging the MHRAimported PLPIproduct

You assessmentcan unitfind youthe shouldlist includeof confirmationPLPI ofvariation thiscodes, agreementincluding insubmission yourrequirements application.and Thefees, MHRAhere.

Where PLPIrelevant, unityou canmust givealso yousubmit thisa incomplete thesample formscan of anthe emailimported or letter.product.

IfYou youmust aresubmit submittingvariation aapplications highthrough volumethe ofMHRA portal. 

If submissions,you (inare excesssubmitting ofmore than 50 variationsvariation applications at the same time)time, pleaseyou informmust tell MHRA at least 3 working days before the submission by emailing 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)(TaD) variations

TaDTaD is 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 MHRA.

TheThe TaD procedure 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: as TaD variations:

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

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

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

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

NoteNote:

• 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 forfor TaD variations 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 thethe MHRA incorporating MHRA incorporating any changes to artwork, as necessary.
2. Companies must include a a TaD Cover sheet for PLPI Companies (MS (MS Word Document,Document, 48 48KB) with 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 toto PLPI.Samples@mhra.gov.uk PLPI.Samples@mhra.gov.uk..
4. Multiple variations for a single licence may be submitted asas TaD variations, 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,changes, TaD is TaD is not permitted.
5. Collections are not permitted for TaD variations.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.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.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.ukPLPI@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

AA PLPI is PLPI is granted for 5 years.

YouUpdates can’t make any 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 youryour PLPI licence PLPIusing licencethe MHRA Portal. usingOnly the MHRARenewal Portal.electronic application form should be submitted.

Inspections of parallel import companies

PLPIPLPI assessors assessors may accompany inspectors on on good manufacturing practice (GMP)(GMP) inspections inspectionsof PLPI companies 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 forfor PLPI applications PLPI applications and variations

Make a payment to MHRAto MHRA

Contact

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

If you have a question about the validation of your submission or the progress of your application email 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 emailemail MHRA Customer MHRA Customer Services at at MHRACustomerServices@mhra.gov.uk or or call 020 3080 6000.