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Environmental Risk Assessment

Definition of ERA

Directive 2001/83/EC states that Environmental Risk Assessments (ERAs) are necessary for new marketing authorisation applications (MAA) of medicinal products or variations thereof. The main objective of ERAs is to systematically investigate chemicals applied within drugs and medicinal use, and chemicals which are intended for respective applications. In this context, the focus of ERAs lies on the analysis of applied chemicals and chemicals intended for use and whether they can be processed as intended without causing adverse effects to human health or the environment.

 

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IASON consulting Services

IASON consulting has been offering full-service marketing authorisation support within the health science industry since 2004. Our one-stop shop services include guidance, review, scientific support, and the compilation of full or partial medicinal product applications, reviews, and reports for national and international approval of respective authorities such as EMA and FDA as well as for in-house use.
We gladly advise you regarding the necessity, preparation, and execution of your specific ERA according to guidelines as provided by, for example, the OECD (Organisation for Economic Co-operation and Development).

 

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