Abstract
The EU has issued Directive 81/852/EEC (EU 1981) in which is stated that with a request for registration of a veterinary medicinal product, information is to be provided to enable an assessment of the safety for the environment. In 1997 the Committee for Veterinary Medicinal Products (CVMP) issued a Note for Guidance on the environmental risk assessment (EMEA 1997a) outlining procedures, trigger values and backgrounds to the proposed risk assessment methodology, in order to harmonise the assessment procedure in Europe. The proposed methodology is based on the hazard quotient approach, that is widely used in the environmental risk assessment frameworks of new and existing substances and of plant protection products and biocides (ECB 1996a; EU 1997a,b).
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Montforts, M.H.M.M. (2001). Regulatory and Methodological Aspects Concerning the Risk Assessment for Medicinal Products; Need for Research. In: Kümmerer, K. (eds) Pharmaceuticals in the Environment. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-04634-0_14
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DOI: https://doi.org/10.1007/978-3-662-04634-0_14
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