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A worker diligently fills out pharmacovigilance documentation, ensuring compliance with the EMA's Guideline on Good Pharmacovigilance Practices (GVP Module IV). This scene highlights the importance of risk-based audits for Marketing Authorisation Holders (MAH) to maintain a robust pharmacovigilance system.

PhV

The legislation on pharmacovigilance from July 2012 established legal requirements for the Marketing Authorisation Holder (MAH) to perform regular risk-based audits of its pharmacovigilance (PhV) system. The guidance on planning and conducting the legally required audits are included in the Guideline on Good Pharmacovigilance Practices (GVP Module IV) of the European Medicines Agency (EMA). Having adequately qualified and experienced auditors SciencePharma provides risk-based audit services to provide independent, objective opinion on the MAH pharmacovigilance system.

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