Various confidential clients
Article 8(3) of Directive 2001/83/EC requires the submission of an evaluation of the potential environmental risks posed by medicinal products in any new marketing authorisation application.
To conduct an environmental risk assessment of human medicines.
Phase 1 risk assessments were undertaken according to guidance issued by the European Medicines Agency (EMEA). Existing company data were reviewed to determine whether they met the EMEA requirements if risk assessments needed to proceed to Phase 2.
Confidential reports for the clients were provided, which included the evaluation, curriculum vitae and signature of one of wca's environmental safety experts. The reports can be included in the application for a marketing authorisation.
Start and completion dates
wca project co-ordinator