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India Specifies Requirements For Pharmacovigilance System Master File, Qualified Person

Executive Summary

The Indian government has borrowed some EU concepts while framing a pharmacovigilance guideline for marketing authorization holders. The guideline, effective January 2018, requires marketing authorization holders to maintain a pharmacovigilance system master file within India where the main pharmacovigilance activities take place, and to hire a pharmacovigilance qualified person to oversee the entire system.

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