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List of Field Safety Notices: 02-06 February 2026
Information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.
1. Overview This guidance is designed to provide information on the…
Guidance on what pharmacovigilance is and compliance issues from previous inspections.
Comply with good pharmacovigilance practice and prepare for an inspection.
This guidance clarifies the expectations on the application of the further pharmacovigilance provisions set out within the updated CIR 520/2012 for UK authorised products.
Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.
A programme to help decision making across the lifecycle of products, benefitting both regulatory and health technology assessment (HTA) evaluations.
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
The Wellcome Trust has funded a 3-year project focusing on effective regulation and evaluation of digital mental health technology.
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