What question did this study set out to answer?

To identify data gaps in environmental risk assessments (ERAs) for veterinary medical products and assess the need for a monograph system.

February 8, 2026Open Access

Monographs for active substances in veterinary medical products Data gaps and availability of environmental information

Puntos clave

To identify data gaps in environmental risk assessments (ERAs) for veterinary medical products and assess the need for a monograph system.
Reviewed marketing authorisation procedures for veterinary pharmaceuticals since 2005.
Analyzed available environmental risk assessment data for active substances.
Listed active substances in Germany requiring Phase II ERA.
Considered substance properties and intended uses based on veterinary guidelines.
Approximately 500 veterinary active substances are marketed in Europe.
Less than 20% of these substances qualify for in-depth Phase II environmental risk assessment.
The feasibility study recommends implementing a monograph system to address data gaps.

Resumen

Since 2005 an environmental risk assessment (ERA) has been required for all new veterinary pharmaceuticals within the marketing authorisation procedure. Since then the availability of ERAs is continuously increasing, but there are still veterinary pharmaceutical substances on the market for which no ERA data exists. Art. 156 of the new veterinary regulation (EU) 2019/6 initiated a review of the rules for environmental risk assessment. The recently published “Feasibility study of an active-substance-based review system (‘monographs’) and other potential alternatives” by the European Commission (https://doi.org/10.2875/94477) recommends a monograph system. However, information is lacking for how many veterinary pharmaceutical substances complete ERA data are available to draft monographs and for which substances ERA data are still missing. At present, about 500 different veterinary active substances are marketed in Europe. Only a limited number of these are environmentally relevant and used in food producing animals. Following VICH GL 6 and the EMA supporting GL, based on their substance properties or their intended use and the subsequent exposure of the environment, less than 20% would be considered for an in-depth experimental environmental risk assessment according to the VICH GL 38 (Phase II ERA). This poster will list all active substances authorized in Germany for which a Phase II ERA is required. Considering all veterinary medical products marketed in Germany in 2020, we will provide information for which active substances information on their environmental safety is available or still missing. This substance lists will aid in predicting the workload during the implementation of a monograph system.

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