Methodological Aspects Concerning the Environmental Risk Assessment for Medicinal Products; Research Challenges

2008 ◽  
pp. 393-408 ◽  
Author(s):  
M. H. M. M. Montforts
Keyword(s):  
Risk Assessment ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Medicinal Products ◽  
Research Challenges ◽  
Methodological Aspects

scholarly journals Critical discussion of the current environmental risk assessment (ERA) of veterinary medicinal products (VMPs) in the European Union, considering changes in animal husbandry

2021 ◽  
Vol 33 (1) ◽  
Author(s):  
Ruth Haupt ◽  
Céline Heinemann ◽  
Jason Jeremia Hayer ◽  
Simone Magdalene Schmid ◽  
Miriam Guse ◽  
...  
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Phase I ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Animal Husbandry ◽  
The European Union ◽  
Medicinal Products ◽  
The Eu ◽  
Veterinary Medicinal Products

Abstract Background Veterinary medicinal products (VMPs) administered to livestock might affect the environment. Therefore, an environmental risk assessment (ERA) is conducted during the approval process of VMPs. In the European Union (EU), the ERA, which was established approximately 10 years ago, consists of two phases. In the present review, we examined the first phase. In this phase, VMPs are subjected to a decision-making process comprising 19 questions and several tables with default values published in the “Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (European Medicines Agency 2016).” Since a proportion of livestock husbandry systems is currently shifting toward ecological husbandry and free-range production systems, there is a lower risk of VMP consumption in general, but livestock excretions possibly containing VMPs might be directly released into the environment instead of being stored and applied as manure. In the present study, the first phase of the current ERA of VMPs in the EU was critically discussed with respect to the changes in animal husbandry. The large number of default values used in the ERA were checked for topicality. In a three-step approach, firstly trends and changes in animal husbandry in Europe that might be relevant for the ERA were collected, secondly, the interactions between Phase I and animal husbandry were evaluated and thirdly, the default values used in Phase I were verified in order to identify research gaps. Results Several default values used in the current ERA were identified as outdated. Together with the lack of valid data (e.g., on animal husbandry systems or VMP treatments), this may have an impact on the predicted environmental concentration (PEC) as the central decision threshold of the ERA. Conclusions The results of the present study indicate that an update of the ERA of VMPs in the EU is required to consider the changes in animal husbandry. Several aspects related to this issue are critically discussed.

Environmental risk assessment of medicinal products for human use according to European Commission recommendations

2004 ◽  
Vol 19 (3) ◽  
pp. 226-240 ◽  
Author(s):  
Gerd Huschek ◽  
Peter D. Hansen ◽  
Hans H. Maurer ◽  
Dietmar Krengel ◽  
Anja Kayser
Keyword(s):  
Risk Assessment ◽  
European Commission ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Medicinal Products ◽  
Human Use
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