RPi TrainingFollowing a recent announcement by the MHRA this article highlights the importance of the RPi role after the transition period has finished and the RPi training available from Inspired Pharma
Following a recent announcement by the MHRA this article highlights the importance of the RPi role after the transition period has finished and the RPi training available from Inspired Pharma.
The role of the RPi
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)’.
The RPi has a number of important responsibilities. These include:
- They need to implement a system to confirm that the required QP certification has taken place for products that have been imported into Great Britain from countries on an approved country for import list (initially, this will be countries in the EEA). The RPi may delegate the activity of checking QP certification has taken place but remains responsible for ensuring the effectiveness of these checks.
- Also, they need to ensure that products imported from a listed country are not the subject of a recall or reported as stolen and are available on the market within the listed country’s licensed supply chain.
- They also need to implement a process to confirm the status of the unique identifier for Prescription Only Medicines
So, this is now a very important role within the UK pharmaceutical industry and clearly organisations will need to recruit and train people to meet this new requirement.
The MHRA announcement highlighted several ways to qualify as an RPi including a Quality Management System Lead Auditor or the Pharmaceutical GMP Lead Auditor qualification awarded by the Chartered Quality Institute.
RPi training courses from Inspired
Our Pharmaceutical GMP Lead Auditor qualification meets this requirement with thousands of delegates attending this course from across the globe over the past 10 years. Find out more by selecting the link in this paragraph.
We also offer a 3-day intensive Responsible Person training course that is aimed at people who want to become a Responsible Person (RP) and is based on and includes the requirements of the Cogent Gold Standard for trainee RPs.
See the full announcement from the MHRA for more details.
Find out about our course ranges