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Toxics 2014, 2(1), 35-49; doi:10.3390/toxics2010035

Risk Mitigation Measures: An Important Aspect of the Environmental Risk Assessment of Pharmaceuticals

1 ECT Oekotoxikologie GmbH, Boettgerstrasse 2-14, 65439 Floersheim/Main, Germany 2 Hamburg University of Applied Sciences (HAW), Lohbrügger Kirchstraße 65, 21033 Hamburg, Germany 3 Fraunhofer Institute for Toxicology and Experimental Medicine—ITEM, Nikolai-Fuchs-Str. 1, 30625 Hannover, Germany 4 Federal Environment Agency (Umweltbundesamt), IV 2.2, Wörlitzer Platz 1, 06844 Dessau-Rosslau, Germany 5 Fraunhofer Institute for Molecular Biology and Applied Ecology—IME, Auf dem Aberg 1, 57392 Schmallenberg, Germany These authors contributed equally to this work.
* Author to whom correspondence should be addressed.
Received: 13 December 2013 / Revised: 13 January 2014 / Accepted: 16 January 2014 / Published: 28 January 2014
(This article belongs to the Special Issue Risk Assessment of Environmental Contaminants)
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Within 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.
Keywords: authorization; environmental risk assessment; medicinal products; risk mitigation authorization; environmental risk assessment; medicinal products; risk mitigation
This is an open access article distributed under the Creative Commons Attribution License (CC BY) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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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.

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