Summary of Product Characteristics

The Summary of Product Characteristics (SPC or SmPC) is a specific document required within the European Commission before any medicinal product or biocidal product is authorized for marketing. This document is required under a number of different European Regulations, e.g. Regulations concerning medicines and Regulations concerning biocidal products. Depending on which Regulation this document is required under the fields contained in the summary may vary. However, in general this summary is the definitive description of the product both in terms of its properties, chemical, hazardardous properties, pharmacological and pharmaceutical etc. and the clinical use or industrial use to which it can put. The EU provide on the use of this document for applicants.