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Glossary

Anonymization Report (AR)

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Part of the Policy 70 submission package. It should describe the methodology of the anonymisation applied in the submitted clinical reports, and how the risk of re-identification has been addressed.

Other glossary definitions

E

Emerging Safety Issue

A safety issue considered by a marketing authorization holder to require urgent attention by the…

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E

Environment Scanning

Identification of the stakeholders which are likely to use, benefit or assess the health tech…

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