Human Medicinal Products
1 December 2006
Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use EMA/CHMP/SWP/4447/00 corr 2
Adoption by CHMP: 1 June 2006
Date for coming into effect: 1 December 2006
Draft version: Revised Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use EMA/CHMP/SWP/4447/00 Rev. 1
Consultation closed: 30 June 2019
Veterinary Medicinal Products
1 March 2009
Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 EMA/CVMP/ERA/418282/2005-Rev.1- Corr.
Adoption by CVMP: 13 November 2006
Date for coming into effect: 1 March 2009
1 November 2018
Guideline on Assessing the Environment and Human Health Risks of Veterinary Medicinal Products in Groundwater EMA/CVMP/ERA/103555/2015
Adoption by CVMP: 19 April 2018
Date for coming into effect: 1 November 2018
You can check Tox by Design methodology for Environmental Risk Assessments, which are duly validated and signed by an European Registered Toxicologist expert.
In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted that Tox by Design is duly accredited for the French Research Tax Credit CIR.
Feel free to contact us using the Quotation Request below to receive a quotation for Environmental Risk Assessment of your drug products.