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Changing Regulatory Information Gets Easier For Pharma As Of February

This article was originally published in SRA

Executive Summary

As of Feb. 1, marketing authorization holders operating in the EU will no longer have to submit type IA variations to notify the competent authorities of any changes they make relating to their qualified person responsible for pharmacovigilance (QPPV) and pharmacovigilance system master files (PSMFs)1.

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