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ECJ judgement means generics firms cannot rely on pre-EU data

This article was originally published in SRA

Executive Summary

A ruling by the European Court of Justice in a case that dealt with complex issues surrounding the data exclusivity granted to medicinal products has major implications for the pharmaceutical industry. The ruling essentially means that a product that was initially granted a marketing authorisation under national rules and which was never updated to meet current EU legislative requirements cannot be used as a reference medicinal product for the approval of a generic version containing the same active substance.




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