Environmental risk assessment of pharmaceuticals
According to European legislation the potential environmental risks posed by medicinal products should be assessed as a prerequisite for obtaining marketing authorisation. The requirements for an environmental risk assessment (ERA) for pharmaceuticals are described by recently adopted or revised guidance documents. These new requirements for environmental risk assessments of pharmaceutical products represent a big challenge for all stakeholders. The assessment of environmental risks for human pharmaceuticals has to be conducted according to the EMEA guideline on Environmental Risk Assessment of Medicinal Products for Human Use (EMEA, 2006, EMEA/CHMP/SWP/4447/00/2006). ERAs for veterinary pharmaceuticals have to follow the EMEA guideline on Environmental Impact Assessment for Veterinary Medicinal Products (EMEA, 2008, EMEA/CVMP/ ERA/418282/2005-Rev.1 as revised in 2008) in support of the VICH guidelines GL 8 (2000) and GL 38 (2004).
ecotox consult • Dr. Michael Meller • ecotoxicological consulting service...
...supports you in complying with European chemical legislation, and provides tailor-made solutions for your regulatory needs. Please feel free to contact Michael Meller for additional information concerning the ecotoxicological aspects of the market authorisation procedure of pharmaceutical products for human and veterinary use.
Offered ecotoxicological services:
- data evaluation, and identification of data gaps;
- development of environmental risk assessment strategies;
- design, monitoring, evaluation, and assessment of ecotoxicological studies;
- literature research;
- preparation of environmental risk assessments, and ecotoxicological expert opinions;
- support by acting as a link between industry, authorities and contract research organisations (CROs).
