A Veterinary Medicinal Product (VMP) is defined as any substance or combination of substances presented for treating or preventing disease in animals.
Any substance or combination of substances which may be administered to animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in animals is likewise considered a veterinary medicinal product.
The Directive 2001/82/EC
The basic rules governing the marketing of Veterinary Medicinal Products within the European Union is the Directive 2001/82/EC which states that no VMP may be placed on the market in a Member State (MS) without a marketing authorization granted by the Competent Authority of that MS.A variety of VMPs are administered to aquatic individuals, added to their diet or directly to the water, or even injected into their organisms.
Many others VMPs are used in intensively reared animal systems where animals are kept and raised in confined areas.
Many others VMPs are applied on pasture animals reared for part or all of the year on grassland for which the excretion occurs directly onto the pasture or onto other habitats within the grazed area.
Different environmental comparts are involved following the VMPs use and the current legislation requires that an Environmental Impact Assessment (EIA) has to be provided for each new application, including generics.
EIA – Phase I
EIA is designed as a tiered approach starting from Phase I in which, based on the intended use of VMP, the potential environmental exposure is assessed.
The decision tree of the Phase I takes into account the concentration and the distribution of the substance respect to natural environmental level, its use in food or non-food animals, its metabolic pattern in treated animals, the limited or broad number of animals to be treated, the type of species treated (aquatic or terrestrial), if it is possible to avoid the entry of the VMP in the specific environmental compart by waste disposal, the comparing of the Predicted Environmental Concentration (PEC) or the Environmental Introduction Concentration (EIC) to the set threshold values. Based on the outcomes from Phase I the assessment can be ended at this stage or it can go on in Phase II to address issues of concern.
EIA – Phase II
The Phase II consists of 2 tiers: Tier A and Tier B. Tier A uses more simple and economic studies to obtain a conservative risk assessment based on the exposure and the effects in the relevant environmental comparts. The approach is to compare the risk quotient (RQ) to 1, if RQ < 1 for each taxonomic level tested then it may be assumed that the VMP does not pose an environmental risk unless the active substance persistence suggests a potential for bioaccumulation in the environment. If RQ > 1 the exposure estimation may be refined considering information about metabolism/excretion and data on biodegradation in manure/soil/aquatic systems. If RQ is still > 1 for some of the taxonomic levels tested then the VMP evaluation goes on in Tier B in order to test the taxonomic levels affected in Tier A.
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