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Glossary

Redaction

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In relation to Policy 70, the process of permanently obscuring CCI or PPD in the clinical documentation submitted to EMA by the applicant/MAH before the documents are published. The redaction should appear as a light blue box with a black ‘PPD’ label or as a black box with a red ‘CCI’ label.

Other glossary definitions

P

Periodic Summary Reporting

Alternative reporting regime that is agreed between the manufacturer and the National Competent Authority for…

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D

Device User Facility

A hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility as…

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