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Introduction |
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Introduction to the Environmental Risk Assessment (ERA) |
Medicinal products for human use are governed by the Directive 2004/27/EC of the European parliament and of the council of 31 March 2004 amending the Directive 2001/83/EC, in which the concept of environmental risk assessment was discussed.
An Environmental Risk Assessment (ERA) is required with a marketing authorisation application for human use pharmaceuticals.
According to Article 8(3) of amended Directive 2001/83/EC, the assessment of the potential environmental risks posed by medicinal products should be submitted, their environmental impact should be evaluated and, on a case-by-case basis, specific arrangements to limit the impact should be considered.
The European Medicines Agency (EMA) published on 1 June 2006, a guideline for ERA on medicinal products for human use; this document was adopted by CHMP and became effective on 1 December 2006.