ERA

ERA

ERA – Environmental Risk Assessment of Medicinal products

On June 1st 2006 the European Medicines Agency (EMEA) published the final document on ERA (Environmental Risk Assessment) on medicinal products for human use adopted by CHMP that become effective on December 1st of that same year.

Any an application for a marketing authorisation of a medicinal product for human use must be accompanied by an ERA. In accordance with Article 8(3) of Directive 2001/83/EC, and following amendments (such as Directive 2003/63/EC, 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.

Due to its extensive technical experience Chemsafe can assist pharmaceutical companies for the application of the ERA on new drugs.

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
  • Fast response
  • Invoicing plan adjustable upon request
  • Convenient payment conditions
  • Visits to the client included