Definitions

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Chapter: Pharmacovigilance: Legal Basis – EU

The definitions of key pharmacovigilance concepts apply to all European pharmacovigilance and are set out in Title I of Directive 2001/83/EC.


DEFINITIONS

The definitions of key pharmacovigilance concepts apply to all European pharmacovigilance and are set out in Title I of Directive 2001/83/EC. The Commission provides guidance on their interpretation in Volume 9.

An ‘adverse reaction’ is a response to a medic-inal product which is noxious and unintended and which occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physi-ological function. Volume 9 advises that an adverse reaction, contrary to an adverse event, is characterised by the fact that a causal relationship between the drug and the occurrence is suspected.

A ‘serious adverse reaction’ means an adverse reaction which results in death, is life threaten-ing, requires inpatient hospitalisation or prolonga-tion of existing hospitalisation, results in persistent or significant disability or incapacity or is a congen-ital anomaly/birth defect. Volume 9 advises that a serious adverse reaction also includes serious adverse clinical consequences associated with use outside the terms of the Summary of Product Characteristics (including, e.g. prescribed doses higher than those recommended), overdoses or abuse. Important adverse reactions that are not immediately life threatening or do not result in death or hospitalisation, but may jeop-ardise the patient, should be considered as ‘serious’.

An ‘unexpected adverse reaction’ means an adverse reaction, the nature, severity or outcome of which is not consistent with the Summary of Product Char-acteristics. Volume 9 advises that this includes reac-tions related to the class of products within which the particular product falls, which are mentioned in the Summary of Product Characteristics but which are not specifically described as occurring with the product.

For nationally authorised products, the relevant Summary of Product Characteristics is that approved by the competent authority in the Member State to whom the reaction is being reported. For centrally authorised products, the relevant Summary of Product Character-istics is that authorised by the European Commission.

‘Abuse of medicinal products’ means the persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological effects.

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