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Qdossier Qsauri
"D"

data exclusivity
Guideline or reference source
EMA Glossary of terms
Definition
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  

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