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Human regulatory: overview. Post-authorisation. Pharmacovigilance: post-authorisation. Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU).
Specific quality objectives and quality requirements for the specific structures and processes of the pharmacovigilance systems are provided in each Module of GVP as appropriate. The quality system is part of the pharmacovigilance system and consists of its own structures and processes.
- Transfer of the guidance on emerging safety issue to GVP Module IX; - Editorial amendments to align the format with other GVP Modules.
Mar 30, 2023 · Discover the essentials of good pharmacovigilance practice with our comprehensive guide to EMA GVP modules. Learn about monitoring medicines safely, complying with regulations, and ensuring patient safety.
This new guidance on good pharmacovigilance practices (GVP) is organised into two types of chapters, namely Modules on pharmacovigilance processes and Product- or Population-Specific Considerations.
Guideline on good pharmacovigilance practices (GVP) – Module VI (Rev 2) EMA/873138/2011 Rev 2 - Draft for public consultation Page 4/164 116 VI.C.6.2.3.5. Suspected adverse reactions related to quality defect or falsified medicinal
There are 12 GVP modules labeled I to XVI, which cover major pharmacovigilance processes. (Module numbers XI, XII, XIII and XIV are null since the EMA already addressed their planned topics in other guidance documents.) Let’s look at each module and see how they play a part in keeping patients safe:
