Environmental safety assessment for Pharmaceuticals

We offer support for the environmental safety assessment for Veterinary Medicinal Products (VMPs) and Medicinal Products for Human use.

Veterinary Medicinal Products

The requirement for assessment of environmental safety for Veterinary Medicinal Products (VMPs) was introduced into the legislation by Directive 92/18/EC. Since that time data on ecotoxicity have been required as part of the safety submission for a Marketing Authorisation (MA).

The environmental assessment should be carried out in two phases. In the first phase the extent of environmental exposure should be estimated while in the second phase the fate and effects of the active residue should be assessed.

REACh ChemConsult GmbH offers support in the environmental safety assessment according to the VICH guidelines on Environmental Impact Assessment for Veterinary Medicinal Products GL6 and GL38. In addition the EMEA/CVMP/ERA/418282/2005-guideline will be used in support of the VICH guidelines GL6 and GL38. This guideline will come into effect on 1 November 2007.

Medicinal Products for Human use

The guideline for the environmental risk assessment of medicinal products for human use came into effect on 1 December 2006 (EMEA/CHMP/SWP/4447/00).

An Environmental Risk Assessment (ERA) shall accompany an application for a marketing authorisation for a medicinal product for human use and is required for all new marketing authorisation applications.

REACh ChemConsult GmbH gives support in the evaluation of the potential risks of the medicinal product to the environment and offer expertise to support the Environmental Risk Assessment Report according to guideline EMEA/CHMP/SWP/4447/00.

In accordance with Article 8(3) of Directive 2001/83/EC, as amended, the evaluation of the potential environmental risks posed by medicinal products 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. In any event this impact should not constitute a criterion for refusal of a marketing authorisation.