European Union regulatory guidance activities

Consequently, the environmental risk assessment (ERA) of medicinal products has to be evaluated and appropriate legislation and regulatory guidance has been issued in the European Union (EU). Recently, Directive 2001/83/EC [12], as amended by Directive 2004/27/EC [13], requires an evaluation of the potential environmental risks to be performed for every application for each active ingredi-ent/excipients from every medicinal product to be authorized. However, the... 

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