DIKUL - logo
ALL libraries (COBIB.SI union bibliographic/catalogue database)
  • Izzivi na področju okoljske ocene tveganja za veterinarska zdravila [Elektronski vir]
    Kolar, Boris, 1960-
    During the marketing authorisation procedure of veterinary medicines products (VMPs), a product-based environmental risk assessment (ERA) has to be provided for all new applications, including ... generics. The result of the ERA of VMPs is part of the benefit/risk analysis. When the VMP presents a risk to the environment, and no risk mitigation measures can mitigate this risk, the benefit/risk balance may be negative, resulting in a refusal of a marketing authorisation. It's been more than a decade since the guidance on the environmental risk assessment of VMPs was published. Since then, several new challenges in the ERA of VMPs were identified. Authorization of persistent, bioaccumulative and toxic (PBT) substances becomes increasingly restricted, while the assessment of the risk of antiparasitics used on pasture animals to the dung fauna showed to be extremely complex and costly. The intense discussion of assessment of VMPs in relation to the risk for groundwater ecosystem is based on the new knowledge of the impact of VMPs to the freshwater compartment and acknowledgement of the groundwater as an ecosystem (not just a source of drinking water). Increasing concern related to the antimicrobial resistance is based on the finding of remains of antibiotics in the environment. Environmental compartments, communities and species are not exposed to VMPs only through the excrements. "Ad hoc" risk assessment was performed on European necrophagous birds (mainly vultures) that might feed on corps of cattle and pigs, previously treated with VMPs containing diclofenac. These birds are proven to be extremely sensitive to non-steroidal anti-inflammatory drugs.
    Source: Farmakološko aktivne snovi v odpadnih vodah [Elektronski vir] : optimizacija analitskih metod in procesov odstranjevanja : zbornik konference = Pharmacologically active substances in wastewater : optimisation of analytical methods and removal processes : proceedings of the conference (Str. 63-65)
    Type of material - conference contribution ; adult, serious
    Publish date - 2016
    Language - slovenian
    COBISS.SI-ID - 91021313

Shelf entry