Non-clinical guidelines: environmental risk assessment

The European Medicines Agency's scientific guidelines on environmental risk assessment help medicine developers prepare marketing authorisation applications for human medicines.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

Guidelines

• Environmental risk assessment of medicinal products for human use
• Environmental risk assessments for medicinal products containing, or consisting of, genetically modified organisms (GMOs)
• Scientific requirements for the environmental risk assessment of gene-therapy medicinal products