Guidance on MAH and QPPV location

AI Summary

This regulatory guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) details the requirements for Marketing Authorisation Holders (MAHs) regarding legal presence and pharmacovigilance oversight. Under the established regulatory framework, an MAH must ensure the permanent availability of a Qualified Person responsible for Pharmacovigilance (QPPV) to manage the safety systems for all UK-authorised products. The QPPV may reside and operate in either the UK or the EU/EEA; however, if they are based outside the UK, the company is required to appoint a national contact person located within the UK. Additionally, the MAH itself must be established in the UK, EU, or EEA to legally sell or supply products in Great Britain or Northern Ireland. A notable exception involves the unfettered access route, which requires the MAH to be established in Northern Ireland when seeking Great Britain recognition for products approved in that territory. Required actions for companies include aligning their corporate establishment and personnel residency with these standards to ensure continuous compliance. While UK-based QPPVs and MAHs are recognized for domestic authorizations, they are generally not accepted for EU-wide procedures, except under specific historical conditions involving EU-based personnel prior to April 2022.