Guidance

Guidance on pharmacovigilance procedures

This guidance summarises our approach to pharmacovigilance

From:
Medicines and Healthcare products Regulatory Agency
Published
31 December 2020
Last updated
288 OctoberJanuary 20222025 — See all updates

Documents

Guidance on pharmacovigilance procedures

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Fig 1: Submission Requirements - Study Protocol or Substantial Protocol Amendment for Non-Interventional PASS

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Fig 2: Submission Requirements - Final Study Report or Interim Study Results for Non-Interventional PASS

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This file may not be suitable for users of assistive technology.

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If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.