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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

A

Anonymization Report (AR)

Part of the Policy 70 submission package. It should describe the methodology of the anonymisation…

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J

Justification Table

In relation to Policy 70, to be completed by the Applicant to justify the proposed…

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