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Engage Early To Assess Possible Referral Outcomes, Generics Firms Advised

This article was originally published in SRA

Executive Summary

Drug companies should ensure early involvement of their regulatory affairs personnel in EU referral procedures to help anticipate possible outcomes and facilitate their smooth implementation. There have been examples recently where the burden of implementing certain referral outcomes such as conducting additional post-authorization studies, has led companies, especially generic manufacturers, to withdraw their marketing authorization rather than comply with the new obligations, reports Vibha Sharma.

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