Earlier today (05 December 2023) Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on Medicines: "Apply for a Parallel Import Licence" in which it updated its MR-DC product list.
This guidance explains the steps involved in applying for a parallel import license in the UK, including the pharmacovigilance requirements.
What is a Parallel Import (PLPI)?
The UK parallel import licensing scheme lets a medicine authorized 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.
Application submissions should be made through the MHRA portal (PLPI submission document requirements) and any submission not meeting the requirements will be invalidated and rejected, and the entire application must then be resubmitted.
A PLPI is granted for 5 years and Renewals must be submitted in the 3 months before the licence expires.
Click this LINK to know more about How to get a parallel import license for your medicine in the UK.
Also, check this guidance "Medicines that you cannot export from the UK or hoard" which sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
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