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Risk Mitigation Measures: An Important Aspect of the Environmental Risk Assessment of Pharmaceuticals
AbstractWithin EU marketing authorization procedures of human and veterinary medicinal products (HMP and VMP), an environmental risk assessment (ERA) has to be performed. In the event that an unacceptable environmental risk is identified, risk mitigation measures (RMM) shall be applied in order to reduce environmental exposure to the pharmaceutical. Within the authorization procedures of HMP, no RMM have been applied so far, except for specific precautions for the disposal of the unused medicinal product or waste materials. For VMP, a limited number of RMM do exist. The aim of this study was to develop consistent and efficient RMM. Therefore, existing RMM were compiled from a summary of product characteristics of authorized pharmaceuticals, and new RMM were developed and evaluated. Based on the results, appropriate RMM were applied within the authorization procedures of medicinal products. For HMP, except for the existing precautions for disposal, no further reasonable measures could be developed. For VMP, two specific precautions for disposal and 17 specific precautions for use in animals were proposed as RMM.
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Liebig, M.; Floeter, C.; Hahn, T.; Koch, W.; Wenzel, A.; Römbke, J. Risk Mitigation Measures: An Important Aspect of the Environmental Risk Assessment of Pharmaceuticals. Toxics 2014, 2, 35-49.View more citation formats
Liebig M, Floeter C, Hahn T, Koch W, Wenzel A, Römbke J. Risk Mitigation Measures: An Important Aspect of the Environmental Risk Assessment of Pharmaceuticals. Toxics. 2014; 2(1):35-49.Chicago/Turabian Style
Liebig, Markus; Floeter, Carolin; Hahn, Thorsten; Koch, Wolfgang; Wenzel, Andrea; Römbke, Jörg. 2014. "Risk Mitigation Measures: An Important Aspect of the Environmental Risk Assessment of Pharmaceuticals." Toxics 2, no. 1: 35-49.