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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).
- Transfer of the guidance on emerging safety issue to GVP Module IX; - Editorial amendments to align the format with other GVP Modules.
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.
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
Dec 18, 2014 · Good Pharmacovigilance Practice ( GPvP) is the minimum standard for monitoring the safety of medicines on sale to the public in the UK. The MHRA inspects marketing authorisation holders (...
