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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 dealers 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 manufacturers 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.

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 werent 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.

For all function sites outside the UK and within the EEA 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 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

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