2021-03-02 12:55 Product Information (PI) is an intrinsic part of the application for marketing authorization of a new drug or medicine. In the European Union, it includes the Summary of Product Characteristics (SmPC) and the Package Leaflet (PL); it names the authorization holder and sets out the conditions of the authorization. The equivalent of the SmPC in the United States is the United States Prescribing Information (USPI). MedTrans provides PI translation service that includes translation into 24 EU and European Economic Area (EEA) languages. A linguistic review of product information in all EU languages is performed after adopting CHMP Opinions to ensure high quality and consistent product information of Centrally Authorised Products (CAPs) in all Member States.
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