Importing investigational medicinal products into Great Britain from approved countries

AI Summary

This MHRA guidance outlines the regulatory requirements for sponsors of clinical trials importing investigational medicinal products (IMPs) into Great Britain from 'approved countries,' which currently includes all EU and EEA members. Under this framework, any UK Manufacturing and Import Authorisation (MIA(IMP)) holder must establish a comprehensive assurance system to oversee their supply chains. The primary requirement is to verify that a Qualified Person (QP) in the listed country has certified the products before they are released to trial sites. A significant benefit of this policy is that IMPs already certified by a QP in an approved country do not require further recertification once they arrive in Great Britain, reducing redundant testing and administrative burdens. While the document does not list specific company violations or inspection dates, as it is a general policy directive rather than an enforcement action, it mandates that all trial sponsors review their supply chains immediately to ensure compliance with these oversight protocols. Organizations are encouraged to coordinate with trade associations like the ABPI or contact the MHRA directly to ensure their assurance systems meet the necessary legal standards for trial safety and product integrity.