Acting as a Responsible Person (import)

AI Summary

This guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the requirements for wholesale dealers importing medicines into Great Britain from approved countries, such as those in the European Economic Area. Governed by the Human Medicines Regulations 2012 (specifically Regulations 45AA and 45AB), the framework mandates the appointment of a ‘Responsible Person (import)’ (RPi) to oversee the legal safety and quality of imported products. The RPi is tasked with verifying that every batch of medicine has received Qualified Person (QP) certification and, for biological products, an independent batch release certificate from the National Institute for Biological Standards and Control (NIBSC) or a recognized partner. Key obligations for companies include implementing a robust system to check batch documentation and ensuring supply chain security to prevent the entry of recalled or stolen goods. To qualify as an RPi, individuals must be UK residents with at least two years of experience as a Responsible Person, hold a relevant degree in life sciences or pharmacy, and maintain full membership in a recognized professional body. Required actions for compliance include registering eligible RPi candidates via the MHRA Portal and ensuring all medicines are certified before importation, as shipping under quarantine is generally prohibited. This guidance became effective on January 1, 2021.