Transcription of Guidance on adverse drug reactions - GOV.UK
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Guidance on adverse drug reactions - GOV.UK
1 Guidance on adverse drug reactions Guidance on adverse drug reactions Contents What is an adverse drug reaction? .. 1 Classification of adverse drug reactions .. 1 How to identify adverse drug reactions .. 2 The burden of adverse drug reactions .. 2 Signal detection .. 3 Data mining .. 3 Signal detection criteria at the MHRA .. 4 Signal assessment .. 4 Signal prioritisation .. 4 Taking regulatory action to minimise risk .. 5 What is an adverse drug reaction? An adverse drug reaction (ADR) is a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. adverse reactions may arise from use of the product within or outside the terms of the marketing authorisation or from occupational exposure. Conditions of use outside the marketing authorisation include off-label use, overdose, misuse, abuse and medication errors.
An adverse drug reaction (ADR) is a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Adverse reactions may arise from use of the product within or outside the terms of the
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