“Environmental risk assessment of medicinal products for human use” according to EMEA/CHMP/SWP/4447/00 Rev. 1

The marketing authorisation of medicinal products for human use (HMP) requires an environmental risk assessment (ERA, CTD Module 1.6.1). It is based on the maximum daily dose (MDD) and depends on the physico-chemical, ecotoxicological, and fate properties of the active substance(s).

Numerous changes and new features arise from the revision, e. g., with regard to the test strategies to be used (e. g., antibiotic agents), the assessment of possible secondary poisoning and the methodology. The guideline is significantly more comprehensive and the requirements are more stringent. It provides a detailed overview of the assessment and a decision tree for Phase I.

The Online Seminar provides a detailed explanation for the preparation of ERAs according to the revised guideline. New features and the impact they have on preparation of ERA are addressed.

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