March 13, 2025

Pharmacovigilance (PV) plays a crucial role in ensuring the safety and efficacy of medicinal products. The Medicines and Healthcare products Regulatory Agency (MHRA) mandates that Marketing Authorization Holders (MAHs) and Qualified Persons for Pharmacovigilance (QPPVs) adhere to strict reporting guidelines when making changes to the PV system. Recent updates in MHRA’s guidance have introduced new procedures to simplify notification requirements, reducing the administrative burden on MAHs while ensuring compliance with UK regulations.

Understanding the Pharmacovigilance System and Its Regulatory Framework

A PV system is designed to monitor the safety of medicines, detect adverse drug reactions (ADRs), and ensure regulatory compliance. In the UK, the MHRA oversees PV activities to protect public health and requires MAHs to maintain an up-to-date PV system.

Any changes to the PV system, particularly those affecting the QPPV, PV System Master File (PSMF), or serious risk management processes, must be communicated to the MHRA in a timely and appropriate manner.

Latest Changes in MHRA Notification Process

Previously, updates to the PV system, including changes to the QPPV and PSMF location, required submission via a Type IAIN variation within 14 days. However, amendments to the guidance, published in May 2023 and further updated in November 2023, have removed this requirement for certain changes, simplifying the process. Instead, affected product licenses (PLs) now need to be updated via an SPS (Summary of the Pharmacovigilance System) update notification, which has no associated fee and is processed within 30 days.

When Should You Notify the MHRA?

Changes to the PV system that require notification include:

Change of QPPV

  • If the QPPV is replaced or their contact details change.

Change of PSMF Location

  • If the location of the PSMF changes within or outside the UK.

Change of UK QPPV Office Address

  • If the registered UK address of the QPPV changes.

Significant Changes to the PV System

  • Including major process updates, restructuring, or outsourcing of key PV functions.

Changes to the PSMF Number

  • If the PSMF number changes due to a Change of Ownership (COA), this must still be submitted via a Type IAIN variation.

How to Notify the MHRA

1. Change of QPPV

Timelines: Notify the MHRA within two weeks of the QPPV change.

Process: Submit the change via the MHRA Human Medicines Portal or as a variation through the submission’s portal.

Required Information:

  • New QPPV’s name, qualifications, and contact details.
  • Date of change.
  • Confirmation that the new QPPV has access to the PSMF.
  • Updated details in the PSMF summary.

2. Change of PSMF Location

Timelines: Notify within 14 calendar days of the change.

Process: Submit via the submissions portal under a Type IA(IN) variation.

Required Information:

  • Updated PSMF location details.
  • Confirmation that the PSMF remains accessible to the QPPV and authorities.

3. Change of UK QPPV Office Address

Timelines: Notify the MHRA as soon as possible, preferably before the change takes effect.

Process: Submit as a Type IA variation.

Required Information:

  • New office address details.
  • Confirmation that the change does not impact the QPPV’s availability.

4. Significant Changes to the PV System

Timelines: Notify immediately upon implementation if the change impacts safety monitoring.

Process: Include in regulatory submissions, such as variations or risk management updates.

Required Information:

  • Detailed explanation of changes.
  • Justification for changes and potential impact on patient safety.
  • Updated PSMF if applicable.

5. SPS Update Notification Process (New Guidance)

If the UK PSMF number remains unchanged, an SPS update notification must be submitted instead of a Type IAIN variation. The submission should include:

  • Cover letter detailing the changes being made to the SPS (PDF format).
  • SPS Update Notification form (Excel format), including sections A, B, and C.
  • Updated SPS document (PDF format) containing:
    • Proof that the MAH has a qualified UK QPPV residing and operating in the UK or EU.
    • The country where the QPPV resides and carries out their tasks.
    • Contact details of the QPPV.
    • Signed statement confirming that the MAH has the necessary means to fulfill pharmacovigilance responsibilities.
    • Reference to the UK location where the PSMF is electronically accessible.

Once submitted, the MHRA processes the update within 30 days and issues a letter of acceptance.

6. Changes to the PSMF Number

If the PSMF number changes due to a Change of Ownership (COA), it cannot be submitted via an SPS update. Instead, it must be included in the COA application or submitted as a Type IAIN variation within 14 days of COA approval.

Consequences of Non-Compliance

Failure to notify the MHRA of significant changes to the PV system can lead to:

  • Regulatory action, including compliance inspections.
  • Fines or license suspension.
  • Increased scrutiny on future PV activities.

To avoid penalties, it is essential to maintain accurate records and ensure all updates are submitted within the required timelines.

Best Practices for Managing PV System Changes

To ensure smooth compliance, MAHs should:

  • Develop a Standard Operating Procedure (SOP) for tracking and notifying PV system changes.
  • Maintain up-to-date records of QPPV details and PSMF location.
  • Regularly review regulatory updates from the MHRA to stay informed of changes in notification procedures.
  • Conduct internal audits to verify compliance with PV obligations.

Conclusion

The MHRA’s updated guidance on notifying changes to the PV system emphasizes the importance of transparency and proactive compliance. By following the correct notification procedures, MAHs can ensure regulatory adherence, minimize risks, and contribute to the ongoing safety of medicinal products in the UK market.

For further information, always refer to the official MHRA guidance documents or consult a regulatory affairs specialist for tailored support.

For expert regulatory guidance on PV compliance, contact Maven.