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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