Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Environmental Risk Assessment - Part of the overall Risk / Benefit Assessment of veterinary medicinal products ***

Dr. Michael Lammers (Abschlußjahr: 2008)

Language: English

The use of VMP is likely to result in an exposure of the environment to pharmacological active substances, as not all active ingredients will be completely metabolised in the treated animal. Pharmacological potential of some active substances might be harmful to one or more non-target species, might it be microbes, plants or animals, and thus result in negative effect on the environment. This ecotoxical potential of a VMP has to be assessed by the applicant and the results presented in the marketing application dossier. In order to characterise the effect on the environment and to identify possible risk mitigation measures the assessment has to follow a common standardized approached, which has been published in EMEA guidances. The guidelines establish a system, which excludes a high percentage of VMPs from cost intense ecotoxical studies. For these VMPs the applicant merely has to bring evidence, that the active is a natural substance or is not expected to enter the environment at great amounts. VMPs that are likely to be used in a high number of animals and at high doses are expected to entry the environment at great amounts and thus investigation on their ecotoxical potential has to be performed by means of a study battery. Basically, this group of critical products includes VMPs that are indicated for the use in almost endemic infectious diseases in intensively reared animals or used as parasiticides in pasture animals. Until now neither the pharmacological nor the toxicological potential of the active are considered, which results in a risk of not identifying highly ecotoxical substances.

The environmental risk assessment itself is based on a risk quotient approach, where the risk quotient is determined by the ratio of the predicted environmental concentration and the predicted no effect concentration. Only a risk quotient exceeding the value of one will lead to acceptance of the VMP, in other cases suitable risk mitigation measures have to be introduced by the applicant or in a worst case the application will be refused.

Pages: 52