{"id":654,"date":"2026-09-20T18:18:32","date_gmt":"2026-09-20T16:18:32","guid":{"rendered":"https:\/\/www.pqra.gr\/environmental-risk-assessment-for-veterinary-medicines-vich-gl6-gl38-and-the-two-phase-model\/"},"modified":"2026-09-20T18:18:37","modified_gmt":"2026-09-20T16:18:37","slug":"environmental-risk-assessment-for-veterinary-medicines-vich-gl6-gl38-and-the-two-phase-model","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/environmental-risk-assessment-for-veterinary-medicines-vich-gl6-gl38-and-the-two-phase-model\/","title":{"rendered":"Environmental Risk Assessment for Veterinary Medicines: VICH GL6, GL38 and the Two-Phase Model"},"content":{"rendered":"

Veterinary medicines reach the environment by routes that human medicines largely do not: through manure spread on land, through direct excretion at pasture, through aquaculture treatments entering water. Regulation (EU) 2019\/6 requires an environmental risk assessment as part of the safety package, and the methodology follows the VICH guidelines. For products used in livestock or fish, this can be one of the most demanding parts of the dossier.<\/strong><\/p>\n\n

Two phases<\/h2>\n

The assessment is structured in two stages. VICH GL6 covers Phase I, the environmental impact assessment for veterinary medicinal products, with a legal effective date of 20 July 2000. VICH GL38 covers Phase II and took legal effect on 1 October 2005. The European Medicines Agency has published a supporting guideline on environmental impact assessment of veterinary medicinal products in support of VICH GL6 and GL38, which sets out a comprehensive approach to conducting the assessment in the EU context.<\/p>\n\n

Where Phase I stops<\/h2>\n

Phase I is a decision-tree exercise that asks whether meaningful environmental exposure is plausible at all. The assessment can conclude at Phase I in defined situations, including where the product will be used only in non-food animals, or where it is intended for a minor species treated and reared in the same way as a major species for which an assessment already exists.<\/p>\n

This is the single most commercially significant feature of the framework. A companion animal product and a livestock product with the same active substance can face radically different environmental workloads. Knowing at which point your product exits Phase I, or fails to, should inform the development plan before studies are commissioned.<\/p>\n\n

Phase II<\/h2>\n

Where Phase I does not resolve the question, Phase II under VICH GL38 requires environmental fate and effects data, assessed against predicted environmental concentrations. In 2008 the CVMP developed additional technical guidance in support of both VICH guidelines, with recommendations on calculating environmental exposure based on European farming practices. That European specificity matters: exposure modelling built on non-EU assumptions may not be accepted.<\/p>\n\n

Practical points for planning<\/h2>\n