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ERA (environmental risk assessment) essential - except generics?

Veterinary drug manufacturers are now required to include an environmental risk assessment (ERA) as part of the benefit/risk assessment of a veterinary product, in accordance with Directive 2004/28 EC. Dr Joop de Knecht, senior assessor at the Dutch national institute for public health and environment, RIVM, reviews the legislation that is available to guide veterinary drug manufacturers through the ERA, hinting a possible exemption for generics.


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