ENVIRONMENTAL RISK ASSESSMENT REPORTS
ERA is required for all new marketing authorization applications of medicinal product for human or veterinary use.
ERA is the process through which the European Medicines Agency ensures that the potential effects of pharmaceuticals on the environment are studied and adequate precautions are taken in case of specific risks identified (see EMEA/CHMP/SWP/4447/00).
The Assessment is a step wise approach:
The outcome of the assessment is a report which collects the scientific evaluation, based on the characteristics of the product, potential toxicity, fate and effects; and it is a key driver in order to establish an appropriated risk minimization strategy. Each report is individual and handled confidential. If environmental studies are necessary we can manage them with qualified external partners (6-8 month). The time for ERA report preparation up is up to 3 weeks if no studies must be performed. Benefit from the knowledge and experience of a multidisciplinary team that count with certified members by AETOX, EUROTOX and ERT.