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Glossary

Commercially Confidential Information (CCI)

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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

C

Common Technical Document (CTD)

The structure and format of applications to be submitted to regulatory authorities in the USA,…

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E

Expedited Criteria

Criteria that should be fulfilled for expedited reporting. The four minimum information required for expedited…

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