Consulting services for chemical industry

ERA - Environmental Risk Assessment of medical products

On June 1st 2006 the European Medicines Agency (EMEA) published the final document on the ERA (Environmental Risk Assessment) on medicinal product for human use adopted by CHMP that become effective on December 1st of the same year. ERA is requested to accompany an application for a marketing authorisation for a medicinal product for human use. In accordance with Article 8(3) of Directive 2001/83/EC and following amendments the evaluation of the potential environmental risks posed by medicine should be submitted, their environmental impact should be assessed and, on a case by case basis, specific arrangements to limit the impact should be considered.

Risk Assessment is prepared using a software called EUSES (European Union System for evaluation of substances).
The document is coded EMEA/CHMP/SWP/4447/00.

Chemsafe can assist pharmaceutical companies for the application of the ERA on new drugs based on its experience to prepare Environmental Risk Assessment got since many years.
In particular:

ERA RELATED ACTIVITIES OFFERED

"On site" training courses
Phase I

Screening of persistence, bioaccumulation and toxicity
PEC calculation (Predicted Environmental Concentration)

Phase II, Tier A

Testing planning (aquatic compartment)
Testing and study monitoring
PNEC calculation (Predicted Non Effective Concentration)
Effects analysis and risk assessment

Phase II, Tier B

Testing planning and data collection (extended programme)
Testing and study monitoring
Effects analysis and risk assessment
Contact and discussion with the Competent Authority
Final report including robust study summaries

Service features

Single key contact
Flexible Approach
Competitive prices
Quick response
Invoicing plan adjustable upon request
Convenient payment conditions
Visits to the client included

Back