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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

P

Post-Market Clinical Follow-up (PMCF) plan

The documented, proactive, organized methods and procedures set up by the manufacturer to collect clinical…

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C

Clinical Impact

The effect that something is likely to have on the treatment of a particular group…

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