Good pharmacovigilance practice (GPvP)

AI Summary

The MHRA conducts Good Pharmacovigilance Practice (GPvP) inspections to ensure UK Marketing Authorisation Holders (MAHs) maintain high standards for monitoring medicine safety. This regulatory oversight, governed by the UK Human Medicines Regulations 2012 (SI 2012 No. 1916), covers routine, triggered, and pre-authorisation assessments of pharmacovigilance systems. Inspections identify deficiencies graded as Critical, Major, or Minor based on their impact on patient safety and public health. For instance, Omega Pharma Limited was issued an infringement notice on October 9, 2013, due to regulatory breaches, highlighting the MHRA's enforcement capabilities for persistent non-compliance. Key violations typically involve failures in data management, inadequate safety reporting, or flawed risk management plans. When deficiencies are identified, the MAH must submit a formal response within 25 working days. This response must include a thorough root cause analysis, an assessment of the impact on the safety profile, and a detailed Corrective and Preventive Action (CAPA) plan with specific deadlines. The MHRA may escalate serious findings to the Compliance Management Team (CMT) or the Inspection Action Group 2 (IAG2). These bodies may recommend triggered re-inspections or further regulatory action to ensure public health is protected. While most inspections are announced, the agency retains the right to perform unannounced visits to any site performing pharmacovigilance activities for UK products.