Medical Science and Medical Writing
Environmental Risk Assessment
The environmental risk assessment in Module 1.6 is an increasingly important part of the drug approval dossier. It is required for all new applications for marketing authorisation as part of a central, decentralised, mutual recognition or national procedure. The general considerations, the assessment procedures, possible risk-minimising measures and the structure of the environmental risk assessment report are presented in two guidelines.
As part of the implementation of the EU Green Deal, the Supply Chain Due Diligence Act, the Corporate Sustainability Reporting Directive and the Environmental Social Governance, there are further obligations of the marketing authorisation applicant to submit information on e.g. sustainability and the reduction of pollutant load on the environment (including entry into the water cycle and measures for elimination or reduction).
Our experts can provide you with comprehensive advice on this topic and compile the appropriate environmental risk assessment report for your product (according to Guideline EMEA/CHMP/SWP/4447/00 Rev. 1 or EMEA/CHMP/BWP/473191/2006 – Corr), so that the requirements of Directive 2001/83/EC are taken into account in your application for marketing authorisation approval, accordingly.