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UK MHRA's: Apply for a Parallel Import Licence (Guidance Update)

Today (17 August 2022) MHRA updated its Guidance on "Medicines: apply for a parallel import licence"

The guidance in general details about How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.

What is a Parallel Import (PLPI)?

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.


PLPI applications fall into 3 categories based on Common Origin:


1. Simple - 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.This is the traditional ‘common origin’ criterion for parallel import licences.


2. Complex - This category applies when the UK and imported products do not share a common origin.


3. 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.


The update was regarding the inclusion of the Updated MR-DC product list.


Click this LINK to know more about the Documents for submission, Variation, renewal, fees etc about the parallel import licence.

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