Environmental impact assessments (EIAs) are required for marketing authorisation applications for veterinary medicinal products under Directive 2001/82/EC. This requirement applies to all new veterinary medicines, as well as for existing products requiring a market authorisation renewal. Conducting the EIA is a tiered process, beginning with a desk exercise. Specific assessments are undertaken for products released primarily into the aquatic environment (e.g. aquaculture) or the terrestrial environment. Aquatic or terrestrial exposure estimates are compared against default action limits.
If the limits are exceeded, mitigations which may alter the estimates may be considered. If the default action limits are still exceeded, a full risk assessment of the environmental fate and effects of the active ingredient is required. This is a Phase II assessment.
The availability of data can vary considerably between new and existing medicinal products. For new products, the data required for a Phase II ERA will need to be generated. For existing medicines or for existing active ingredients to be used in a new medicinal application some of the necessary information and some data may already be available.
At wca environment we have extensive experience in assisting companies in conducting ERAs according to VICH guidelines. Our veterinary medicines ERA services extend to:
- Phase I ERA
- Phase I reports
- Calculation of aquatic and terrestrial exposure estimates
- Evaluation of possible mitigations (degradation and management practices) that may alter the exposure estimates
- Phase II ERA
- Review of existing company data and open literature data for use in Phase II
- Where data gaps are apparent we have the expertise to initiate and monitor environmental fate and effects studies on behalf of the client:
- Obtain and compare quotes from Contract Research Organizations (CRO)
- Advice on tiered testing; definition of testing programme
- Study protocol review and agreement with CRO
- Study monitoring
- Peer review of draft study reports
- Modelling of aquatic and terrestrial Predicted Environmental Concentrations (PECs)
- Preparation of Environmental Impact Assessment Report for submission with the dossier
- Post-submission support with authorities