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Toxics 2014, 2(1), 35-49;

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

ECT Oekotoxikologie GmbH, Boettgerstrasse 2-14, 65439 Floersheim/Main, Germany
Hamburg University of Applied Sciences (HAW), Lohbrügger Kirchstraße 65, 21033 Hamburg, Germany
Fraunhofer Institute for Toxicology and Experimental Medicine—ITEM, Nikolai-Fuchs-Str. 1, 30625 Hannover, Germany
Federal Environment Agency (Umweltbundesamt), IV 2.2, Wörlitzer Platz 1, 06844 Dessau-Rosslau, Germany
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. View Full-Text
Keywords: authorization; environmental risk assessment; medicinal products; risk mitigation authorization; environmental risk assessment; medicinal products; risk mitigation

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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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