Medicines, medical devices and blood regulation and safety – 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.

Overview

The UK parallel import licensing scheme lets a medicine authorised in another EU Member State be marketed in the UK, as long as the imported product has no therapeutic difference from the same 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.

The normal requirements for reporting adverse reactions and defects apply to parallel import 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.

MHRA carries out initial assessment and variation assessment workshops every year, if you would be interested in attending email plpi.workshops@mhra.gsi.gov.uk.

Parallel import licence application categories

Parallel import licence (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
  • 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.

Labels, patient information leaflets and packaging

All labels, patient information leaflets (PILs) and packaging for parallel import medicines must comply with European 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 info@mhra.gsi.gov.uk if you want further information.

During assessment of any initial PLPI application, the excipients are checked to make sure that the EU product to be imported is bioequivalent to the UK product.

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

For all other medicines, only those with excipients with known effects should be declared on the labelling.

European Medicine Agency guidelines give the wording for the patient information leaflet. These warnings must be included in the leaflet even if they weren’t in the UK PIL.

User testing patient information leaflets

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, 88.1KB, 10 pages) .

Company functions involved in parallel importing

You 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.

For all function sites outside the UK and within the EU member states, 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 get the product from if you electronically submit the statement below. The statement should be signed and emailed as a PDF to plpi@mhra.gsi.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:

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.

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.

Tell and do (TaD) variations

TaD is a procedure which allows you to submit a variation for a change to the imported product and then carrying on repackaging and distributing the product while MHRA assesses the variation.

The incoming product must be linked with the cross-referred UK product via a mutual recognition or decentralised procedure.

You can only submit TaD variations following a probation period and when you have written confirmation from MHRA.

You will be charged the usual fee for a variation.

It may not be appropriate to submit variations as a TaD if there are other variations to the same product that are not TaDs.

Variations using TaD can only be made for the following changes:

  • name/address of the marketing authorisation holder in the source country
  • manufacturer name/site
  • excipients
  • description/appearance of dosage form
  • storage conditions

You cannot use a TaD variation to change the imported marketing authorisation number.

Make a TaD variation

To make a TaD variation you need to check if the imported product is a MR/DC product. The list is updated often.

See MR-DC product list (PDF, 362KB, 51 pages) - 24 August 2016.

Find the marketing authorisation number of the imported product and then make sure the UK MA number on the list is identical to the cross-referred UK licence on your licence. If your PLPI licence is cross-referred to a different UK licence you cannot do a TaD.

Submit your variation adding the following statement in the reason box on the variation application form ‘TaD – update xxxx’ and complete the variation application form (MS Word Document, 32.5KB) .

You can then make the changes to the PIL and labels and continue repackaging and releasing the product.

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. If you don’t have access to the portal you should complete the renewal application form (MS Word Document, 26KB) .

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 EU-wide leaflet 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

Submit your parallel import

You should submit the PLPI submission document requirements (PDF, 146KB, 13 pages) through the MHRA portal or using the Common European Submission Platform (CESP).

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.

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.

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

Documents for submission

To make a PLPI submission you need to complete the application form, including 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 (MS Word Document, 44.5KB) :

  • completed label summary template (MS Word Document, 42KB) – even if there is no fee for your application
  • guidance on requests for further information (PDF, 4.06MB, 3 pages) – 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

2 strikes and out initiative

If there is information missing from your submission or changes need to be made we will write to you twice.

If you don’t send the information asked for or make the necessary changes in the timeframe set out in the letter we will decide whether to refuse the application.

A third and final letter will be sent before the application is refused.

In some cases, MHRA will make an exception, for example when the leaflet for the product is undergoing user testing. This will be decided on a case-by-case basis and only in exceptional circumstances.

See renewal application form (MS Word Document, 26KB) .

Fees

Fees for PLPI applications and variations

Make a payment to MHRA

Contact

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

If you have a question about the validation of your submission email Area5-PLPI-submission-queries@mhra.gsi.gov.uk

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

For more general enquiries about PLPIs email info@mhra.gsi.gov.uk or call 020 3080 6000.