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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.

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E

European Medicines Agency (EMA)

Based in London, the EMA is the EU competent authority and publishes the guidelines on…

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E

European Union (EU) Legal Representative

Sponsors who are not based in the EU/EEA must appoint a legal representative based in…

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