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Toe the line or face the fine (5% of EU turnover)

This article was originally published in Scrip

Executive Summary

Legal experts are advising pharmaceutical companies to carefully review the recently amended EU Penalties Regulation, under which certain infringements of paediatric and pharmacovigilance laws for centrally authorised drugs can now lead to financial penalties of up to 5% of the marketing authorisation holder's annual EU turnover. The amended regulation came into force on 2 July.

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