We prepare the environmental risk assessment for veterinary medicinal products

The requirement for assessment of environmental safety for Veterinary Medicinal Products (VMPs) was introduced by Directive 92/18/EC, which is no longer in force. Now, the legal basis is the regulation (EU) 2019/6 on veterinary medicinal products. Since that time data on ecotoxicity have been required as part of the safety submission for a Marketing Authorisation (MA).

The environmental risk 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. If Phase II is necessary, physical and chemical properties as well as certain environmental fate and ecotoxicological properties must be determined. We evaluate the existing data and then recommend carrying out appropriate studies in renowned laboratories for data gaps. Once all the data are available, a risk assessment must then show that the environmental exposure (PEC, predicted environmental concentration) is below the limit values (PNEC, predicted no effect concentration).

We at REACh ChemConsult GmbH offer support in the environmental risk and 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 is being used in support of the VICH guidelines GL6 and GL38. This guideline came into effect on 1 November 2007.

Overview of the applicable guidelines:

• Overview of guidelines: Environmental risk assessment of veterinary medicines
• technical guideline: VICH GL6 Environmental impact assessment (EIAS) for veterinary medicinal products - Phase I - Scientific guideline, CVMP/VICH/592/98-FINAL, Last updated: 30/06/2000
• technical guideline: VICH GL38 Environmental impact assessments for veterinary medicinal products - Phase II - Scientific guideline, CVMP/VICH/790/03-FINAL, Last updated: 01/01/2005
• technical guideline: Environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 - Scientific guideline, EMEA/CVMP/ERA/418282/2005-Rev.1 Corr.1, Last updated: 05/07/2016

Legal basis for the environmental risk assessment:

The Regulation on Veterinary Medicinal Products (Regulation (EU) 2019/6) updated the rules for the authorization and use of veterinary medicinal products in the European Union (EU) when it came into force on 28 January 2022. The regulation requires an environmental risk assessment. The European Medicines Agency (EMA) is working with the European Commission and other EU partners to implement the regulation.

We at REACh ChemConsult GmbH are happy to carry out the environmental risk assessment for your veterinary medicinal products. We would be pleased to work for you. 

Please contact  us for further information and a non-binding offer.