Article from 18.12.2024 | Last changed: 17.06.2025
Environmental aspects of the authorisation of human medicinal pro
… their application for authorisation. The requirements for the ERA are outlined in a guideline issued by the European Medicines Agency (EMA). This guideline was first … on the Predicted Environmental Concentration in surface water (PECsw). The trigger value, known as the "action limit," is 0.01 micrograms per litre. If the calculated … and informational content. For instance, simple citations of endpoints such as EC50 values are not acceptable, as they do not provide information about the conditions …