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Environmental Risk Assessment

Environmental Risk Assessment

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The introduction of Veterinary Medicinal Products (VMPs) into the European Legislation (Directive 92/18/EC) products require a 2-step process to evaluate its properties with regards to environmental risk assessment. As per the VICH GL6 Guideline, the first phase describes the estimation of exposure using different models that take into account the method of administration, target species and characteristics of the constituents of the VMP.

The second phase includes testing of the fate and effects of the residue based on the results from the first phase. The VICH GL38 guideline describes the details of the second phase of the study. It uses a two-tiered approach with an initial set of Physicochemical, ecotoxicity and e-fate studies to produce a conservative assessment. Additional testing may be needed based on the results and the branch of application.

 

JRF Global offers a comprehensive package for Environmental Risk Assessment studies for global submissions, including Toxicology, Product Chemistry, Ecotoxicology, and Efate studies. These studies offered as per the regulatory requirements
from USEPA, EU, Japan etc regulators and in compliance with global guidelines.

 


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