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“Teething Problems” Seen with FMD Implementation: No Shortages but Much Confusion

This article was originally published in The Gold Sheet

Executive Summary

There are “teething problems” in the implementation of the active substance import provisions of FMD, said one EU industry representative while another official called things “a mess” as member states and industry work to sort things out - but the feared drug shortages have not materialized as major API producing countries have ramped up at the last minute and are producing the written declarations attesting that their APIs meet EU GMP requirements.

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