How to Notify the MHRA of Changes to the PV System

The MHRA published guidance updates on how to notify the MHRA about changes to the Pharmacovigilance (PV) system. The revisions came into effect on 11 May 2023 and have been updated on 17 November 2023.

Amendments to the guidance on the MHRA website include changes to the way updates to a marketing authorization holders (MAHs) Pharmacovigilance (PV) system should be notified to the MHRA. The changes aim to make administration burden less for both MAHs and the agency and do not require the submission of a Type IAIN variation any longer.

Background

MAHs for UK authorized products are required by law to keep the MHRA informed at all times of the details of the PV system. This includes details of the UK Qualified Person for Pharmacovigilance (QPPV) and Pharmacovigilance System Master File (PSMF) UK location and number. The information is submitted to the MHRA within the Summary of the Pharmacovigilance System (SPS) document.

What is the new process for notifying the MHRA regarding changes to the PV system?

Where changes to the SPS have been made, a Type IAIN variation will no longer be required to be submitted to notify the MHRA in respect to the following:

• The UK QPPV details, i.e. the UK QPPV name and contact address
• The location in the UK where the UK PSMF can be electronically accessed.

Instead, an SPS update notification covering the affected product licenses (PL), needs to be submitted to register these changes. There will be no fee associated with these notifications. SPS update notifications will be processed by the agency within 30 days of the receipt of the notice.

More information is available in the MHRA Inspectorates Blog Guidance updates on to how to notify the MHRA of changes to the PV System.