United Kingdom

Pharmacovigilance in the United Kingdom is regulated by the MHRA. For UK marketing authorisations, the MAH must have a QPPV who resides and operates in the UK or the EU/EEA—not necessarily in the UK. Where the QPPV is outside the UK, the MAH must appoint a national contact person for pharmacovigilance who resides and operates in the UK and reports to the QPPV. The MAH must maintain a UK PSMF registered with the MHRA and electronically accessible from the UK at the same point from which suspected adverse-reaction reports are accessible; it must be permanently and immediately available for inspection. The MAH must also follow the MHRA pharmacovigilance procedures for ICSR, PSUR, RMP and signal-management obligations and is subject to Good Pharmacovigilance Practice inspections. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.