Annex on Non- Clinical and Clinical Considerations Note for Guidance on the Non- Clinical Documentation of Medicinal Products with Well- Established Use Position Paper on the limits of genotoxic impurities Note for Guidance on the Need for Pre- clinical Testing of Human Pharmaceuticals in Juvenile Animals Note for Guidance on Environmental Risk Assessments for Pharmaceuticals
Points to consider on the evaluation of the pharmacokinetics of medicinal products in the paediatric population Note for guidance on the evaluation of the pharmacokinetics of