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Glossary

Justification Table

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In relation to Policy 70, to be completed by the Applicant to justify the proposed redaction of CCI.

Other glossary definitions

P

Post-Authorization Safety Study (PASS)

A Post-Authorization Safety Study (PASS) is a study performed after the marketing authorization and aiming…

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R

Risk minimization measure

Interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure…

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