Pharmaceuticals and Their Impact on the Environment

Pharmaceuticals are a class of emerging environmental contaminants that are extensively and increasingly being used in human and veterinary medicine and are released continuously into the environment. A variety of pharmaceuticals have been detected in many environmental samples worldwide. The establishment of chemical analysis methods able to determine more polar compounds allow the determination and identification of trace quantities of drugs and their metabolites. Most regulatory agencies require that environmental risk assessment is performed as an integral part of their approval procedures for the marketing for medicinal products. Marketing approval for medicinal products in the European Union is regulated by the Directive 2001/83/EC. Based on the Directive, the European Medicines Agency (EMA) has published guidelines describing the procedure for the environmental risk assessment for medicinal products marketed in the EU. The requirements for the Environmental risk assessment (ERA) in Croatia are regulated by the Medicinal Products Act (Official Gazette No. 71/07) and the Ordinance on the Procedure and Method for Granting Marketing Authorisations for Medicinal Products (Official Gazette No. 113/08).