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.