Client

Various confidential clients

Background

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.

Objectives

To conduct an environmental risk assessment of human medicines.

Methodology

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.

Outcome

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.

Value

Confidential

Start and completion dates

Various

wca project co-ordinator

Melanie Gross