Earlier today Today (13 October 2022) Medicines and Healthcare products Regulatory Agency (MHRA) updated its Guidance on Medicines: "Apply for a parallel import License" in which it updated its MR-DC product list.
This guidance document 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.
There are three categories of PLPI licenses and click this link to know about them from our previous article.
The following conditions must be met in order to parallel import a product:
the product is manufactured to good manufacturing practice (GMP) standards
you hold a wholesale dealer’s license covering importing, storage and sale for each product
you hold the correct parallel import license
To assemble and repackage the product you will also need to have a manufacturer’s license covering product assembly.
You will need an import license from the Home Office if your product is controlled by the Misuse of Drugs Act and Regardless of whether a license is granted, you will still have to comply with any other statutory provisions or third-party civil rights.
Click this LINK to know more about How to get a parallel import license for your medicine in the UK.
Also, there was an update to the guidance on "Apply for manufacturer or wholesaler of medicines licenses" which helps in obtaining, updating, and canceling licenses for the manufacture, import, and wholesale of human and veterinary medicines.