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Glossary

Development safety update report (DSUR)

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Format and content for periodic reporting on drugs under development (ICH-E2F Guideline, Volume 10 of the Rules Governing Medicinal Products in the EU).

Other glossary definitions

M

Market Exclusivity

The 10-year period after the marketing authorisation of an orphan medicine when similar medicines for…

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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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