RPi Guidance

What is an RPi

A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person for import (RPi)

For more information about when an RPi would be required and who can act as an RPi please see the MHRA website - Click Here

When are you required to add an RPi

If you have selected the function Products Certified under Article 51 of Directive 2001/83/EC on any of the sites on your WDA(H) application then you shall need to name a person who will act as the Responsible Person for import (RPi).

If the site in question has been

-      named on the licence prior to 1st Jan 2021

-      and was prior to 1st Jan 2021 importing from Europe

Then provided you submit a variation via the portal prior to 1st July 2021, you may select the function Products Certified under Article 51 of Directive 2001/83/EC on the site/s and not be required to name an RPi until 1st Jan 2023.

How to add an RPi

  1. Go to Section 2 of the WDA(H) Application 2. Site and Personnel
  2. At the bottom of the page beneath 'Add a site' and above the 'Save' and Navigation buttons there is a button to 'Add a Responsible Person for Import'. Clicking on this button will open the RPi form
  3. In section 2.5 Responsible Person for import (RPi) you can select an existing person who has been added to your WDA(H) application or add a new person who will act as the RPi
  4. In section 2.6 Status you should confirm if the person named is a permanent employee.
  5. In Qualified Person you should identify if the person who will act as RPi is a Qualified Person (QP)
    If the person is a QP you will need to attach a copy of their QP Registration
    If the person is not a QP you should confirm their qualification and education experience for this role
    In the Identification section you will need to provide the passport/driving licence and a utility bill
  6. Lastly you need to confirm that you have read the guidance notes on what the RPi duties are - Click Here