What is the UK parallel import licensing scheme?
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.
What do you need if you want to parallel import a product?
- A wholesale dealer’s licence (WDL) covering importing, storage and sale for each product.
- To ensure the product is manufactured to good manufacturing practice (GMP) standards.
- To hold the correct parallel import licence.
What if you want to assemble and repackage the product too?
In this case you will also need to have a manufacturer’s licence covering product assembly.
What if your product is controlled by the Misuse of Drugs Act?
In this case you will need an import licence from the Home Office.
What about the Name of the product?
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.
What about reporting Adverse Events?
The normal requirements for reporting adverse reactions and defects apply to PLPI products.
How is Product Recall handled?
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.
What are the categories of Parallel Import Licence applications?
Considerations for Labels, Patient Information Leaflets and Packaging
All labels, PILs and packaging for parallel import medicines must comply with current guidance. 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.
Is User Testing of PLPI PILs required?
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.
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. For 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 required by MHRA.
Who should your parallel import licence application be submitted to?
You should submit the application (PLPI submission document requirements) through the MHRA portal. Details of what documents to submit can be found here.
How to 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 PIL 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.
How to 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.
If you would like to discuss how Fusion Pharma can support you with Parallel Import Scheme, please email us at email@example.com or phone us on +44 (0) 203 1379 799.