From 1 January 2021, a wholesale dealer in Great Britain may only import Qualified Person (QP) certified medicines from the European Economic Area (EEA) if certain checks are made by the 'Responsible Person (import) (RPi)'
Medicinal products sourced from Northern Ireland for wholesale purposes are out of scope of this guidance. Products without a marketing authorisation in the UK, Northern Ireland, Great Britain or a listed country are outside the scope of this guidance.
RPi is responsible for implementing a system for confirming QP certification and independent batch release certification. The RPi may delegate the activity of checking this certification has taken place but remains responsible for ensuring the effectiveness of these checks. The RPi should ensure that written evidence is available to demonstrate that each batch of product has been QP certified.
Batches of QP certified biological medicines that require independent batch release should not be sold or supplied by the importing wholesale dealer in Great Britain. Checks on products imported from a listed country should also ensure that the product is not the subject of a recall or reported as stolen.
Products supplied as decommissioned must be decommissioned by the final EEA supplier. You have training and an understanding of the industry in order to qualify for the role. There is no requirement for each site on the WDA(H) to name its own RPi.
You must first demonstrate that you are eligible to act as an RPi. This is through a combination of relevant qualifications and experience. It is also expected that you will be a member of a professional body with a published code of conduct.
Qualifications include a diploma, certificate or other evidence of formal qualifications awarded on completion of a university or other higher education course of study in Pharmacy Chemistry Medicine Biology or a related Life Sciences stream.
Equivalent qualifications acceptable for RPi candidates include Level 5 qualifications from Chartered Institute of Logistics and Transport, A Quality Management System (QMS) Lead Auditor or Pharmaceutical GMP Lead Auditor qualification awarded by Chartered Quality Institute. You can check the suitability of your qualifications by emailing to GDP.Inspectorate@mhra.gov.uk.
If you are a person named on the Qualified Persons register you will also be eligible to act as an RPi. You must still apply to be named on the RPi register. You must also demonstrate suitability to be named on a specific WDA(H) licence.
This guidance will apply from 1 January 2021. You will need to provide proof of address and identity when applying.