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Glossary

Commercially Confidential Information (CCI)

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Click a letter to view all its definitions

In relation to Policy 70, CCI shall mean any information contained in the clinical reports submitted to EMA by the applicant/MAH which is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant/MAH.

Other glossary definitions

A

Abnormal Use

Act or omission of an act by the operator or user of a medical device…

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O

Occupational exposure to a medicinal product

For the purpose of reporting cases of suspected adverse reactions, an exposure to a medicinal…

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