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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

S

Scientific Advice

Advice given by a regulatory/ reimbursement authority to a manufacturer on appropriate tests and studies…

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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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