ERA Regulation of Environmental Risk Assessment

Veterinary Guidelines

1996

Veterinary International Conference of Harmonization (VICH) has formed a working group to develop a common guide for the EU, Japan and the USA for the elaboration of Environmental Impact Assessments

Implementation, March 2009: 

EMA/CVMP/ERA/418282/2005-Rev.1

(2016.06.24) Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL 38

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

Human Guidelines

For human medicines, there was no ICH guideline approach.

The US and EU have a different approach, as the EU has ruled separately on human and veterinary medicines.

It should be noted that generics are not exempt from providing an ERA and it is not possible to cross-reference the manufacturer's dossier without the manufacturer's consent.

Adopted, in application since 01/12/2006

Guideline on the Environmental Risk Assessment of medicinal products for human use EMEA/CHMP/SWP/4447/00 corr 2

Clarification and Harmonization (26/05/2016)

Questions and Answers on Guideline on the environmental risk assessment of medicinal products for human use

End of Consultation, 30/06/2019: 

EMEA/CHMP/SWP/4447/00 Rev. 1

Draft of the Guideline on the Environmental Risk Assessment of medicinal products for human use:

• New decision tree clarifying the need for studies and providing technical guidance to MA applicants to increase the consistency of their assessments
• Revised the term "endocrine active substances" to include all products that affect development or reproduction
• Introduction of the concept of exposure of predators to active substances in the food chain or the environment
• Limitation of laboratory tests
• For the calculation of the refined FPen, introduction of the prevalence "prevalence for the region with the highest prevalence”