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Glossary

Summary of product characteristics (SmPC)

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Part of the marketing authorization of a medicinal product setting out the agreed position of the product as distilled during the course of the assessment process which includes the information described in Article 11 of Directive 2001/83/EC. It is the basis of information for healthcare professionals on how to use the product safely and effectively. The package leaflet is drawn in accordance with the summary of product characteristics.

Other glossary definitions

D

Development safety update report (DSUR)

Format and content for periodic reporting on drugs under development (ICH-E2F Guideline, Volume 10 of…

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E

European Network for Health Technology Assessment (EUnetHTA)

The European network for Health Technology Assessment is a network of government-appointed organizations from European…

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