Environmental risk assessment (ERA) for marketing authorisation of veterinary and human medicinal products

Pharmaceuticals that are to be marketed in Europe must always seek marketing authorisation by the competent authorities. The environmental risk assessment (ERA) is an important part of the marketing authorisation application (MAA) dossier.

As the requirements for environmental risk assessments are constantly changing, ambiguities often arise that even the existing guidelines and general EU assessment models cannot fully resolve.

For our clients in the pharmaceutical industry, we evaluate the necessary data, draw up the ERA for the application in line with the regulatory requirements and provide support with compiling all the required documentation, developing suitable testing strategies and engaging in discussions with the competent authorities. Any experimental investigations required can be carried out by both the Fraunhofer institutes and other experienced testing institutes.