Explore: Biological Licence Application (BLA) | Clinical Trial Application Dossier | Narratives | New Drug Application (NDA) | Pregnancy Prevention Plan (or Programme, PPP) | Product Information (PI) | Statistical Analysis Plan (SAP) | Summary of Product Characteristics (SmPC) | United States Prescribing Information (USPI)
Summary of Product Characteristics (SmPC)
- The SmPC sets out the agreed usage of the drug. It provides information on usage for healthcare professionals, and is an intrinsic part of the application for marketing authorisation of a new drug or medicine within the European Union. The SmPC is part of the wider Product Information (PI), which also includes the Package Leaflet (PL) and names the authorization holder, as well as the conditions of the authorization. The equivalent of the SmPC in the United States is the United States Prescribing Information (USPI).
- Trilogy understands the intent and needs of the SmPC and USPI, and is able to help your teams produce a document that is a consistent reflection of the data available from your clinical programme and submission dossier.