Responsible Person Import (RPi) - Role and Requirements

Responsible Person career path
3.50 Hour/s

CPD Hours: 3

Online

The Responsible Person Import (RPi) role is a critical role in the UK pharmaceutical industry, yet it is often misunderstood and misinterpreted. For organisations that hold or are applying for a Wholesale Dealer’s Licence (WDA) and importing medicines from the European Economic Area (EEA), having a RPi named on the license is a regulatory requirement. The RPi ensures compliance with The Human Medicines Regulations relating to importation, ensures evidence of QP certification is available and fully understands the legal responsibilities of importing medicines from the EEA.



Our expert-led course, delivered by Tony Orme - former Expert MHRA GDP inspector and author of the current MHRA RPi guidance, provides an in-depth understanding of the RPi’s role and responsibilities on a WDA. Throughout the course, attendees will engage in several key topics, including:


  • The importance and purpose of the RPi role
  • Defining the RPi role, clarifying the specific legal duties and expectations
  • The essential requirements that should be met by both the Responsible Person Import (RPi) and the Responsible Person (RP)
  • Insight into what inspectors look for to ensure regulatory compliance.



Are you interested in running the Responsible Person for Import (RPi) course in-house for your team? Please contact us

This course is suitable for Responsible Persons, QPs, trainee QPs and Quality Professionals with a GMP background who want to understand the role of the RPi and how to carry out these responsibilities.

The course includes the following sessions:


  • Regulations relating to the RP
  • Interpretation of MHRA guidance
  • How to become an RPi
  • The role of the RPi and the RP
  • Evidence requirements for QP certification
  • Products that don’t require RPi oversight
  • RPi delegation of activities
  • Import under quarantine
  • Real-world case studies

    By the end of the course, delegates will:


    • Understand the role of the Responsible Person Import (RPi) with respect to personal responsibilities and those of the Licence Holder
    • Understand the legislation and licensing requirements for importing medicinal products, including the responsibilities of both the RP and RPi.
    • Understand the evidence that the MHRA requires from the RPi to demonstrate imported medicines have been QP certified.
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Meet the tutors

Tony Orme

Now an independent consultant, Tony had 32 years experience in the regulation of pharmaceuticals with MHRA, with 22 years within the MHRA Inspectorate leading on the most high profile and complex inspections. Tony has been involved in the development of most UK GDP policies and has a deep understanding on the practical application of GDP and the Human Medicines Regulations and the medicines supply chain.

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