data exclusivity

The period of eight years from the initial authorisation of a medicine during which the marketing-authorisation holder benefits from the exclusive rights to the results of preclinical tests and clinical trials on the medicine. After this period, the marketing authorisation holder is obliged to release this information to companies wishing to develop generic versions of the medicine.

More information can be found under 'Data exclusivity / Generics / Biosimilars: Regulatory and procedural guidance'.