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 the EEA member memberstates, the states, MHRA need 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 ( PLPI submission document requirements (PDF, 146 KB, 13 pages)) 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 label summary template (MS Word Document, 59 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

2One strikes‘RFI’ and out initiativeRule

If there is information missing from your submission or changes need to be made, wethe willOne write‘RFI’ toRule youpolicy twicesets ( guidanceout onthat requeststhe forMHRA furtherwill information (PDF,only 4.06issue MB,one 3Request pages)).

Iffor youFurther don’tInformation send(RFI) thefor informationall askedapplications.  forThe orMHRA makewill correspond with the necessaryapplicant changesonce, into explain the timeframeinformation setwhich outis inmissing or the letter,changes wewhich are required. The applicant will decidebe whethergiven one opportunity to refuseaddress the application.

Aoutstanding thirdissues.  andIf finalafter letterthis willthe beapplicant has not sent beforethe information or made the applicationrequired ischanges refused.

Inwithin some30 cases,calendar days, the MHRA will makerefuse anthe exception,application. 

This forpolicy exampleis whenapplicable theto leafletboth forinitial theand productvariation isapplications.

In undergoingsome usercases, the testing.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 doDo (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 carryingcontinue on repackaging and distributing the product while MHRAthe assessesvariation is assessed by the variation.MHRA.

The incomingTaD productprocedure mustfor haveparallel beenimports linkedis withnow based on the cross-referredtype UKof productvariation viaand asafety mutualimplication, recognitionrather orthan decentralisedthe procedure.licensing route of the imported and UK product licence.

YouThe cannew only submit TaD variationsprocedure followingsupersedes athe probationprevious periodparallel import procedure introduced in 2011 and whenthe youstop haveprocess writtenlists confirmation(dated from18/11/2022), MHRA.

Youwhich willare benow chargedboth theredundant usualand feecan forno alonger variation.be used.

ItThe mayfollowing notvariation becodes appropriatemay toonly submitbe variationssubmitted as a TaD ifvariations therewhich are otherdeemed variationsas tolower therisk samevariations: • Code product57 that– arechange notin TaDs.

Variationsthe usingcross-referred TaDUK canlicence only(all bePLPI madelicences). • Code for51 the– followingchange changes:

• name/addressin of the EUMA marketing authorisation holder details (selected). • Code 52 – change in the sourcemanufacturer country
• name (selected). • Code 58 – change in the manufacturer name/site
address (*selected).

Note

• excipients
• description/appearanceAll ofmanufacturer dosageand 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.
• storage*Selected conditions

Younon-CAP cannotimported useproducts amay be eligible for TaD variationvariations (refer to change the importedtable marketingfor authorisationfurther number.

detailed guidance).

Make

All acompanies TaDare variation

Toeligible maketo autilise TaDthe variationTell youand needDo toProcess.

Process

1. A checkvariation ifmust be submitted to the importedMHRA productincorporating isany achanges MR/DCto product.artwork, Theas listnecessary.
2. Companies ismust updatedinclude often.

   Seea MR-DCTaD productcover listsheet for PLPI Companies (PDF,MS 2.21Word MBDocument, 5527 pagesKB) 1with Decemberthe 2023.

   Findsubmission thedocuments.

3. Sample marketingscans authorisationare numberonly ofrequired theto importedbe productsubmitted for non-CAP EU MAH and thenmanufacturer makechanges. Sample surescans themust UKbe MAsent numberto onPLPI.Samples@mhra.gov.uk.
4. Multiple variations for a single licence may be submitted as TaD variations, but only if the listrequirements isas identicallisted toin the cross-referredtable UKbelow are met. If a licence onrequires yourother licence.variation Ifcodes your(excluding PLPICode licence64 is– cross-referredPatient Information Leaflet update) to abe differentsubmitted UKdue licenceto youconcurrent cannotchanges, doTaD ais not permitted.
5. Collections are not permitted for TaD.

   Submit yourvariations.

6. No variationRequests addingfor Further Information (RFIs) will be permitted for variations submitted via the followingTell statementand 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 reasonapplication boxwill onbe refused.
8. If a variation is refused the company must cease processing immediately and resubmit the variation applicationas forma ‘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 updatemay xxxx’continue andprocessing completestock using the variationnew partsubmitted documentation/updated artwork.
11. Any amendments following the approval of the applicationvariation form.
    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.

YouIt canis thenthe makeresponsibility of the changeslicence holder to ensure the PILsafety andof labelstheir andlicensed continueproducts. If repackagingthere are any doubts, use the default position of stop processing and releasingconfirm with the product.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.