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

Toxics

Markus Liebig²  Carolin Floeter¹  Thorsten Hahn³  Wolfgang Koch⁴  Andrea Wenzel⁵ 

[1] Hamburg University of Applied Sciences (HAW), Lohbrügger Kirchstraße 65, 21033 Hamburg, Germany; E-Mail:;ECT Oekotoxikologie GmbH, Boettgerstrasse 2-14, 65439 Floersheim/Main, Germany; E-Mail:;Fraunhofer Institute for Toxicology and Experimental Medicine—ITEM, Nikolai-Fuchs-Str. 1, 30625 Hannover, Germany; E-Mail:;Federal Environment Agency (Umweltbundesamt), IV 2.2, Wörlitzer Platz 1, 06844 Dessau-Rosslau, Germany; E-Mail:;Fraunhofer Institute for Molecular Biology and Applied Ecology—IME, Auf dem Aberg 1, 57392 Schmallenberg, Germany; E-Mail:

关键词: authorization;    environmental risk assessment;    medicinal products;    risk mitigation;   

DOI  :  10.3390/toxics2010035

来源: mdpi

【 摘 要 】

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.

【 授权许可】

CC BY   
© 2014 by the authors; licensee MDPI, Basel, Switzerland.