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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

I

Innovative Licensing and Access Pathway (ILAP)

The MHRA’s Innovative Licensing and Access Pathway (ILAP) aims to accelerate the time to market,…

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F

Field Safety Corrective Action (FSCA)

A Field Safety Corrective Action is an action taken by a manufacturer to report any…

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