A proposal was prepared for the post-authorisation monitoring of veterinary medicinal products, in particular parasiticides. Such a monitoring might especially be useful for parasiticides identified as PBT substances, i.e., substances that are toxic (T), persist in the environment (P) and bioaccumulate (B). Based on a literature search, issues are discussed that have to be considered when performing such a post-authorisation monitoring, e.g. residue analysis, compartments to be included, selection of organisms and the study duration. Based on this discussion it is concluded that the technical performance of such a post-authorisation monitoring is not the main problem, since most of the chemical and biological methods to be used are well known (partly even standardised) or could be adapted. However, it is very difficult to define in detail where and when a monitoring should be performed. The main problem is to link exposure to effects of a certain parasiticide in a way that possible effects can directly be related to the use of this parasiticide. Therefore, a targeted environmental monitoring is proposed, i.e. a long-term field study under farm conditions.
For additional information, see the open access publication in Toxics:
Römbke, J., Duis, K. (2018). Proposal for a monitoring concept for veterinary medicinal products with PBT properties, using parasiticides as a case study. Toxics 6(1):14.
The monitoring concept was performed within a project funded by the German Environment Agency.
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