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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

C

Competent Authority

Is responsible for the authorization of medicines / medical devices and for ensuring that medicines…

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E

EXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)

The submission of data on medicines by marketing-authorisation holders into the EVMPD is a legal…

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