Implementation November 2018
EMA/CVMP/ERA/103555/2015 \(2018.04.30\) Guideline on assessing the environmental and human health risks of veterinary medicinal products in ground water
Adopted, in application since December 2006
Guideline on the Environmental Risk Assessment of medicinal products for human use EMEA/CHMP/SWP/4447/00 corr 2
November 2018: Draft of the Guideline on the Environmental Risk Assessment of medicinal products for human use
End of consultation June 2019: EMEA/CHMP/SWP/4447/00 Rev. 1
You can check Tox by Design methodology for Environmental Risk Assessments, signed by an European Registered Toxicologist expert here.
In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted Tox by Design is duly accredited for the French Research Tax Credit CIR.
Feel free to contact us using this email link to receive a quotation for Environmental Risk Assessments procedure.