Risk Mitigation Measures: An Important Aspect of the Environmental Risk Assessment of Pharmaceuticals
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 en...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2014-01-01
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| Series: | Toxics |
| Subjects: | |
| Online Access: | http://www.mdpi.com/2305-6304/2/1/35 |
| _version_ | 1819163194768228352 |
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| author | Markus Liebig Carolin Floeter Thorsten Hahn Wolfgang Koch Andrea Wenzel Jörg Römbke |
| author_facet | Markus Liebig Carolin Floeter Thorsten Hahn Wolfgang Koch Andrea Wenzel Jörg Römbke |
| author_sort | Markus Liebig |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-22T17:40:16Z |
| format | Article |
| id | doaj.art-6c970ce1ebe94a6b8668cc773d8877fd |
| institution | Directory Open Access Journal |
| issn | 2305-6304 |
| language | English |
| last_indexed | 2024-12-22T17:40:16Z |
| publishDate | 2014-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Toxics |
| spelling | doaj.art-6c970ce1ebe94a6b8668cc773d8877fd2022-12-21T18:18:25ZengMDPI AGToxics2305-63042014-01-0121354910.3390/toxics2010035toxics2010035Risk Mitigation Measures: An Important Aspect of the Environmental Risk Assessment of PharmaceuticalsMarkus Liebig0Carolin Floeter1Thorsten Hahn2Wolfgang Koch3Andrea Wenzel4Jörg Römbke5ECT Oekotoxikologie GmbH, Boettgerstrasse 2-14, 65439 Floersheim/Main, GermanyHamburg University of Applied Sciences (HAW), Lohbrügger Kirchstraße 65, 21033 Hamburg, GermanyFraunhofer Institute for Toxicology and Experimental Medicine—ITEM, Nikolai-Fuchs-Str. 1, 30625 Hannover, GermanyFederal Environment Agency (Umweltbundesamt), IV 2.2, Wörlitzer Platz 1, 06844 Dessau-Rosslau, GermanyFraunhofer Institute for Molecular Biology and Applied Ecology—IME, Auf dem Aberg 1, 57392 Schmallenberg, GermanyECT Oekotoxikologie GmbH, Boettgerstrasse 2-14, 65439 Floersheim/Main, GermanyWithin 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.http://www.mdpi.com/2305-6304/2/1/35authorizationenvironmental risk assessmentmedicinal productsrisk mitigation |
| spellingShingle | Markus Liebig Carolin Floeter Thorsten Hahn Wolfgang Koch Andrea Wenzel Jörg Römbke Risk Mitigation Measures: An Important Aspect of the Environmental Risk Assessment of Pharmaceuticals Toxics authorization environmental risk assessment medicinal products risk mitigation |
| title | Risk Mitigation Measures: An Important Aspect of the Environmental Risk Assessment of Pharmaceuticals |
| title_full | Risk Mitigation Measures: An Important Aspect of the Environmental Risk Assessment of Pharmaceuticals |
| title_fullStr | Risk Mitigation Measures: An Important Aspect of the Environmental Risk Assessment of Pharmaceuticals |
| title_full_unstemmed | Risk Mitigation Measures: An Important Aspect of the Environmental Risk Assessment of Pharmaceuticals |
| title_short | Risk Mitigation Measures: An Important Aspect of the Environmental Risk Assessment of Pharmaceuticals |
| title_sort | risk mitigation measures an important aspect of the environmental risk assessment of pharmaceuticals |
| topic | authorization environmental risk assessment medicinal products risk mitigation |
| url | http://www.mdpi.com/2305-6304/2/1/35 |
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