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Glossary

Audit

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A systematic, disciplined, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled. 

Other glossary definitions

M

Market Exclusivity

The 10-year period after the marketing authorisation of an orphan medicine when similar medicines for…

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P

Personal Data

Any information relating to an identified or identifiable individual; an identifiable person is someone who…

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