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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

R

Risk Management Plan (RMP)

A detailed description of the set of pharmacovigilance activities and interventions designed to identify, characterise,…

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S

Significant risk device

An investigational device that:  Is intended as an implant and presents a potential for serious…

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