Half-Day Course

Course Summary

Importation of human medicines into Great Britain requires oversight by a Responsible Person (Import) — or RPi — in accordance with the UK Human Medicines Regulations 2012/1916 and Directive 2001/83/EC.

This half-day course introduces the role, duties and regulatory responsibilities of the RPi, providing delegates with a practical understanding of how importation activities must comply with Good Distribution Practice (GDP) and MHRA expectations.

Real-world examples, group discussions and scenario-based exercises help participants understand the end-to-end importation process and how the RPi ensures product quality and supply chain integrity and looks into what products are exempt from this requirement.

Finally we will look at how is this role integrated into your current QMS and the crossover and delegation of duties with that of the Responsible Person (RP).

Who Should Attend?

This course is ideal for:

• Existing Responsible Persons
• Qualified Persons (QPs) and Trainee QPs
• Quality professionals seeking to expand their knowledge into importation
• Individuals preparing to become an RPi or support an RPi in their role
• WDA License Holders wishing to understand regulatory importation requirements

Key Learning Objectives

By the end of this training, delegates will be able to:

• ✅ Understand the legal framework for importation under UK Human Medicines Regulations
• ✅ Define the roles and responsibilities of the RPi and how they differ from the RP
• ✅ Recognise which imports require RPi oversight and when exemptions apply
• ✅ Interpret MHRA guidance and inspection expectations relating to RPi activities
• ✅ Appreciate the RPi’s role in quality oversight, documentation review, and QMS integration
• ✅ Apply practical knowledge to ensure compliance, supply chain transparency, and product integrity

Why Choose PMN Consulting?

With over 25 years of industry experience in GMP, GDP, and Importation, and an ex-MHRA Senior Inspector within our team, PMN Consulting delivers high-impact training built on real regulatory insight.

We have supported numerous organisations in obtaining WDA(H) and importation licences, developing compliant Quality Management Systems, and providing contract RPi services — making us ideally placed to deliver this course.

VIA ZOOM FOR BUSINESS
(Link provided a day before the training)

£445+ VAT per delegate
Discounts: 12.5% for 2 delegates; Book 3, pay for 2 delegates; 20% for NHS Employees; Bookings for 4 or more delegates, contact us for a bespoke quotation.