Good Pharmacovigilance Practice

The MHRA Pharmacovigilance Inspectorate is part of the Inspections and Standards Division of the MHRA. It assesses pharmaceutical companies’ compliance with UK and EU legislation relating to the monitoring of the safety of medicines given to patients.


News

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This section includes all the latest news from the Pharmacovigilance Inspectorate.
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Background

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This page provides information about pharmacovigilance and how the MHRA Pharmacovigilance Inspectorate works.
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The inspection process

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This section outlines the Good Pharmacovigilance Practice inspection process and gives details of the types of inspections and how they are carried out.
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Risk-based inspections

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This section provides information about risk-based inspections, why the MHRA is now using this method of inspection and how they work.
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Stakeholder Engagement Meeting

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This section provides information on the Stakeholder Engagement Meeting, which is coordinated by the MHRA Pharmacovigilance Inspectorate.

Pharmacovigilance inspection metrics

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The pharmacovigilance metrics provide information on the number and type of marketing authorisation holders (MAHs) inspected, the areas associated with common inspection findings, as well as the number of critical, major and other findings.

Frequently asked questions

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This section provides answers to frequently asked questions relating to Good Pharmacovigilance Practice.
Page last modified: 30 January 2014