The environmental risks related to human and veterinary pharmaceuticals have to be assessed according to legal requirements within the authorisation procedures for pharmaceuticals. If a risk for the environment is indicated, risk mitigation measures should be proposed by the applicant and implemented within the risk management. The authorisation of a veterinary pharmaceutical can be refused due to specific environmental concerns, whereas for human pharmaceuticals a refusal due to environmental concerns is not possible. So far, risk mitigation measures have been applied only for veterinary pharmaceuticals. Risk mitigation measures for different products with the same active ingredient can differ considerably depending on the registration procedure, the year of authorisation and the reference member state. For human pharmaceuticals, feasible and effective risk mitigation measures are not yet available. Within this project funded by the German Federal Environment Agency (UBA), measures to reduce environmental exposure and risks posed by veterinary and human pharmaceuticals were identified, evaluated and further developed. A catalogue of risk mitigation measures was developed that can be used by applicants and authorities within authorisation procedures of human and veterinary pharmaceuticals. The measures were evaluated based on the criteria practicability, efficiency, sustainability and verifiability.
For further information, see the publication in Toxics:
Liebig, M., Floeter, C., Hahn, T., Koch, W., Wenzel, A., Römbke, J. (2014). Risk mitigation measures – an important aspect of the environmental risk assessment of human and veterinary medicinal products. Toxics 2, 35-49.