Methodology for environmental risk assessment associated with the use of veterinary medicinal products
Journal Title: Medicamentul Veterinar / Veterinary Drug - Year 2013, Vol 7, Issue 1
Abstract
Environmental risk assessment (ERA) is mandatory for all new applications for centralized marketing authorization or national regardless of their legal basis. ERA aims to protect the environment. Risk assessment has two phases of veterinary product evaluation possible role of exposure and its effects. Phase I of the ERA is based on filling a decision tree with 19 questions. If the answers to these questions do not stop the assessment at this stage then is advancing to Phase II. It uses a two stage approach stage A and stage B. The first stage, stage A, studies using simple, less expensive studies. I f the assessment is not complete, then is appealed to Step B to drill ERA. If there is still a risk indicator after filling and assessment in stage B, then, to mitigate risk, is recommended the file discussing and of the proposals for additional data.
Authors and Affiliations
Ioana Tihulca
Keywords
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