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Table 1 Outcome of environmental risk assessments (ERA) for centralised veterinary medicinal products (VMPs) since 1995

From: Regulatory review of the environmental risk assessment of veterinary medicinal products in the European Union, with particular focus on the centralised authorisation procedure

  Number of VMPsa Reason for ending at phase I
Total pharmaceutical VMPs 108  
Products with Phase I only (103 products) 16 Treatment of individual animals
3 Naturally occurring substance (such as electrolytes, peptides, proteins and vitamins that do not alter the natural concentrations in the environment)
15 PEC < 100 µg/kg
69 Use in companion animals only
Products with phase I and II (5  products) 1 PEC > 100 µg/kg
2 Potential PBT
1 High PECsurface water and risk to dung fauna
1 Risk to plants
Total immunological/biological VMPs 101  
Products with a higher tier environmental risk assessment 1 Risk of vaccine spillage to wild population
  1. aData obtained from published European Public Assessment Reports (EPARs) for veterinary medicinal products (centrally) authorised by the European Medicines Agency, from October 2019