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(411) Environmental risk assessment of veterinary medicines - a regulatory view. Tait, Alex1, Long, Carol1, Browning, Andrew1, 1 ABSTRACT- Until 1993 there was no requirement to provide ecotoxicity data as part of the application for a Marketing Authorisation (MA) for a veterinary medicine in the European Union. Since then environmental risk assessment of veterinary medicinal products (VMPs) has become part of the approval procedure. Assessment is a two phase procedure and guidelines are in place to assist those applying for a MA to prepare the environmental assessment. Phase I evaluates the extent of environmental exposure and eliminates those products, where the extent of exposure is low, from the need for further assessment. Phase I assessment requires information on the active ingredient, the indications, the dose, frequency of treatment, metabolism and excretion. All this information should be available in other parts of the dossier. Products for which the Phase I assessment shows that environmental exposure is extensive require assessment in Phase II. The Phase II assessment uses a tiered approach. Tier A requires the production of data on fate and effects of the residue, which may be the active ingredient or a major metabolite, on the environmental compartments of concern. In Tier B further fate and effects data are required to address specific concerns. In the presentation the environmental risk assessment of VMPs will be discussed using generic examples to illustrate the assessment procedure. The advantages and limitations of models available for determination of predicted environmental concentration of residue in the environment will be addressed. Finally the key issues for the future of the environmental assessment of VMPs will be considered. Key words: veterinary, drug, regulatory, assessment |
