Responsible Person Import (RPi) - Role and Requirements
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:
Are you interested in running the Responsible Person for import (RPi) course 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.
This half day course will look in depth at several topic areas related to this key role, including:
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 this 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.
Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you.
We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.
More than 30 years of experience upskilling pharmaceutical professionals
Small-group training adjusted to individual learning styles and needs
50+ training courses accredited by recognised industry bodies
Combination of off-the-shelf and bespoke training packages
Courses and consulting led by experts in the entire pharmaceutical life cycle
Opportunity to share and learn as part of a diverse community
