GNL 24: Data and market exclusivity: what it is and how long it lasts

Data and market exclusivity prevents a generic competitor referencing the pre-clinical and clinical trial data of an authorised reference medicinal product, for eight years, when applying for an abridged marketing authorisation. This period is followed by two years market exclusivity before the generic product can enter the market. A further one year of market exclusivity is possible for reference products that have a new therapeutic indication.

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