
An environmental risk assessment (ERA) is now required for all new pharmaceutical product marketing authorisation applications. The author outlines the steps to this procedure.
D.F. de Roode is Regulatory Affairs Manager at NOTOX B.V. Tel. +31(0)73 640 67 00 Fax: +31(0)73 640 67 99 Email: daphne.de.roode@notox.nl

Published: June 1st 2010 | Updated: