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A Medicinal Product is defined as any substance or combination of substances presented for treating or preventing diseases in human beings. Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product.
Medicinal products are regulated by the Directive 2001/83/EC. According to the implementation of this Directive the evaluation of the potential environmental risks posed by medicinal products should be submitted, their environmental impact should be assessed and, on a case-by-case basis, specific arrangements to limit the impact should be considered.
The Environmental Risk Assessment (ERA) refers to the environmental risks associated with the use, the storage and the disposal of the pharmaceutical products. ERA includes a 2 steps procedure: Phase I and Phase II, the aim of Phase I is to estimate the environmental exposure, while in the Phase II (Tier A and Tier B) the information about the fate and the effects on the environment are derived and assessed.
In Phase I the Predicted Environmental Concentration (PEC) is limited to the aquatic compartment particularly to the surface waters. It is assumed that main entry of the pharmaceutical product into the surface waters is the sewage system, that no biodegradation/retention in sewage treatment plant and that no patients metabolism occur. If the PEC in surface waters is higher than the set threshold value then the evaluation goes on in Phase II. Tier A consists of an initial analyses of the environmental fate and effects of the pharmaceutical product and Tier B consists of a refinement of the PEC, based on the results from environmental fate studies carried out in Tier A, and an extensive analyses of the effects in the organisms living in the relevant compartments.