Introduction
Veterinary Medicinal Products (VMPs) are regulated through the European Medical Agency (EMA). The requirement for assessment of environmental safety for VMPs was introduced into legislation by Directive 92/18/EC. The Directive states that Environmental Impact assessments (EIAs) are mandatory for all new applications and existing products on renewal of market authorization. Further guidance on the consideration of effects can be found in Directive 2001/182/EC, as amended by Directive 2004/28/EC.
What is a Veterinary Medicinal Product?
1. Any substance or combination of substances presented as properties for treating or preventing disease in animals; pr
2. any substance or combination of substances that may be used in, or administered to, animals with a view either of restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolical action, or to making a medical diagnosis.
How the Directive works
The basic framework provided by the Directive was elaborated by guidelines published by the Committee for Medicinal Products for Veterinary Use (CVMP) in 1997. These have since been replaced with the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Products (VICH) guidelines. This is a Trilateral (EU-Japan-USA) programme aimed at harmonising technical requirements for veterinary product registration.
Principles of risk assessment: the risk quotient approach
The environmental risk assessment is based on a risk quotient (RQ) approach, which is the ratio of the Predicted Environmental Concentration (PEC) and the Predicted No Effect Concentration (PNEC) on non-target organisms. PEC is defined as the concentration of the parent compound and metabolites predicted to be present in the soil, water and sediment compartment. PNEC is determined from the experimentally determined effects endpoint divided by an appropriate assessment factor (AF or Safety Factor (SF)). The AF is intended to cover uncertainties and the value varies depending on the type of study conducted.
Study Capability
| STUDY | GUIDELINE |
| Physical-chemical Properties Studies at Tier A | |
| Water Solubility | OECD 105 |
| Dissociation Constants in Water | OECD 112 |
| UV-Visible Absorption Spectrum | OECD 101 |
| Melting Point/Melting Range | OECD 102 |
| Vapour Pressure | OECD 104 |
| n-Octanol/Water Partition Coefficient | OECD 107 or 117 |
| Environmental fate studies at Tier A | |
| Soil Adsorption/Desorption | OECD 106 |
| Soil Biodegradation (route and rate) | OECD 307 |
| Degradation in aquatic systems | OECD 308 |
| Photolysis | Seek regulatory guidance |
| Hydrolysis | OECD 111 |
| Aquatic effects studies at Tier A | |
| Freshwater Algal growth inhibition | OECD 201 |
| Freshwater Daphnia immobilization | OECD 202 |
| Freshwater/Saltwater Fish acute toxicity | OECD 203 |
| Saltwater Algal growth inhibition | ISO 10253 |
| Saltwater Crustacean acute toxicity | ISO 14669 |
| Terrestrial effects studies at Tier A | |
| Nitrogen Transformation | OECD 216 |
| Terrestrial plants | OECD 208 |
| Earthworm Subacute/reproduction | OECD 220 /222 |
| Environmental fate study at Tier B | |
| Bioconcentration in fish | OECD 305 |
| Aquatic effects studies at Tier B | |
| Freshwater Algae growth inhibition | OECD 201 |
| Freshwater Daphnia magna reproduction | OECD 211 |
| Freshwater Fish, early-life stage | OECD 210 |
| Freshwater Sediment invertebrate species toxicity | OECD 218, 219 |
| Saltwater Algae growth inhibition | ISO 10253 |
| Saltwater Crustacean chronic toxicity or reproduction | Seek regulatory Guidance |
| Saltwater Fish chronic toxicity | Seek regulatory Guidance |
| Saltwater Sediment invertebrate species toxicity | Seek regulatory Guidance |
| Terrestrial effects studies at Tier B | |
| Nitrogen Transformation (100 days– extension of Tier A study) | OECD 216 |
| Terrestrial plants growth, more species | OECD 208 |
This page was last updated 02/4/2013 15:46
