Pharmacovigilance requirements: qualified person for PV and PSMF

AI Summary

This guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the mandatory pharmacovigilance (PV) requirements for all companies holding marketing authorisations in the UK. Under the Human Medicines Regulations 2012 and Good Pharmacovigilance Practices (GVP), companies must maintain a robust PV system to monitor drug safety. Key requirements include appointing a Qualified Person Responsible for Pharmacovigilance (QPPV). While the QPPV may reside in the UK or EU/EEA, companies with an EU-based QPPV must nominate a UK-based national contact person to facilitate communication with the MHRA. Additionally, every PV system must have a Pharmacovigilance System Master File (PSMF) assigned a unique UK registration number. Crucially, this file must be electronically accessible from a UK location at all times for inspection purposes. The document introduces a streamlined notification process, effective May 2023. Instead of complex filings, companies can now use a simplified update notification to report changes to QPPV details or PSMF locations. Potential issues include the invalidation of PSMF numbers if the registered access point is not within the UK, which would lead to the rejection of regulatory submissions. Marketing authorisation holders are required to notify the MHRA of system changes within 14 days. This framework ensures that safety monitoring remains consistent and accessible within the UK regulatory environment.