Good Pharmacovigilance Practices
Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the EU. GVP apply to marketing authorisation holders, national regulatory authorities and the European Medicines Agency. The practices relate to medicines authorised at national level as well as medicines authorised centrally at a European level.
GVP Modules
The European Medicines Agency has published a number of GVP modules relating to the implementation of the new pharmacovigilance legislation.
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Module I
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Pharmacovigilance systems and their quality systems
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Module II
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Pharmacovigilance system master file
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Module V
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Risk management systems
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Module VI
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Management and reporting of adverse reactions to medicinal products
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Module VII
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Periodic safety update reports
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Module VIII
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Port-authorisation safety studies
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Module IX
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Signal management
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The remaining modules are being developed and will be released for public consultation. Visit the Public Consultations section of our website for updates on these consultations or visit the GVP section of the European Medicines Agency website.