As a result of the EU pharmaceutical legislation, the European Medicines Agency (EMEA) requires an Environmental Risk Assessment (ERA) for any human or veterinary product you want to market. The ERA will be part of the assessment report that needs to be submitted. An ERA is required for:
All new marketing authorisation applications.
Variations (
type II).
Line extensions (for medicinal products for human use if there is an increase in environmental exposure, e.g. a new indication may result in a significant increase in the extent of the use).
ERA (Environmental Risk Assessment)
ERA consists of two phases. ERA phase 1 for veterinary products can be completed by answering questions in a
decision tree. For medicinal products for human use, phase 1 is an exposure driven screening phase.
When phase 1 shows that no environmental risk is expected, phase 2 is generally not necessary and the ERA is completed at this point. For some veterinary products and for substances that may affect the reproduction of vertebrates or lower animals at concentrations lower than a threshold value, phase 2 is always required!
ERA phase 2 is a full risk assessment based on environmental fate and effect data using a tiered approach. In tier A, a basic data set on environmental fate and effects is used to calculate no-effect concentrations. In tier B, the assessment is further refined when considered necessary. Also selection and assignment of appropriate control measures (risk mitigation measure) are to be considered.