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Veterinary Medicines

Veterinary Medicines

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

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