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Risk mitigation measures: An important aspect of the environmental risk assessment of pharmaceuticals

: Liebig, Markus; Floeter, Carolin; Hahn, Thorsten; Koch, Wolfgang; Wenzel, Andrea; Römbke, Jörg

Fulltext urn:nbn:de:0011-n-2926687 (614 KByte PDF)
MD5 Fingerprint: df0babc9214ff09d6e33d0e02e0fc4f8
Created on: 11.6.2014

Toxics 2 (2014), No.1, pp.35-49
ISSN: 2305-6304
Journal Article, Electronic Publication
Fraunhofer ITEM ()
Fraunhofer IME ()
authorization; medicinal products; risk mitigation; environmental risk assessment

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, 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.