The marketing of a medicinal product in Europe generally requires authorisation from the competent authorities. An important part of this is the environmental risk assessment (ERA). One of the aims of the PREMIER project is to create a database containing ecotoxicological studies and studies on the fate of active pharmaceutical ingredients in the environment, which will allow data to be made available for the development of models for predicting environmental data.

According to this concept, older active substances that have never undergone an ERA could be prioritised for further (environmental) studies. Similarly, data from the active substances can be used to identify potential environmental risks at an early stage for new active substances that are still in development.

Further information can be found here.

We are happy to support you in the preparation of ERAs and your marketing authorisation: our services.