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Testing of Veterinary Medicinal Products according to the Directive 2001/82/EC

LAUS supports you in conducting the environmental risk assessment (ERA) for the registration of your veterinary medicinal product in accordance with the requirements of the European Medicines Agency (EMEA). The test consists of two phases. Phase 2 is, however, only required if certain criteria can not be met in Phase 1.

When is an Environmental Risk Assessment (ERA) required?

  • New applications
  • Generic products
  • Hybrid applications
  • Bibliographic applications
  • Informed consent applications
  • Type II variations
  • Extensions
  • Renewals

All ERA should follow the phased, step-wise approach detailed in the guidelines as issued by VICH (Veterinary International Conference on Harmonization) and adopted by CVMP (Committee for Medicinal Products for Veterinary Use). Together with our partner laboratories, we offer you the complete range of tests according to the principles of Good Laboratory Practice (GLP) with the following services:

Environmental Risk Assessment (acc. CVMP/ERA/418282/2005-Ref.1):

Phase II: Tier A - Assessment

  • Physico-chemical Properties
    • OECD 105 Water Solubility
    • OECD 112 Dissociation Constants in Water
    • OECD 101 UV-Visible Absorption Spectrum
    • OECD 102 Melting Point/Melting Range
    • OECD 104 Vapour Pressure
    • OECD 107 or 117 n-Octanol/Water Partition Coefficient
  • Environmental Fate
    • OECD 106 Soil Adsorption/Desorption
    • OECD 307 Soil Biodegradation
    • OECD 308 Degradation in Aquatic Systems
    • OECD 111 Hydrolysis
  • Aquatic Ecotoxicology (EC50 / LC50)
    • OECD 201 Algal Growth Inhibition Test
    • OECD 202 Daphnia Immobilization Test
    • OECD 203 Fish Acute Toxicity Test
  • Terrestrial Ecotoxicology
    • OECD 216 N-Transformation Test
    • OECD 208 Terrestrial Plants
    • OECD 220 /222 Earthworm Reproduction Test

Phase II: Tier B - Assessment

(Depending on the results of the studies from Tier A)

  • Environmental Fate
    • OECD 305 Bioconcentration in Fish (Should be determined if log Pow is ≥ 4)
  • Aquatic Ecotoxicology (NOEC)
    • OECD 201 Algae Growth Inhibition Test
    • OECD 211 Daphnia magna Reproduction Test
    • OECD 210 Fish, Early-life Stage Test
    • OECD 218 / 219 Sediment Invertebrate Species Toxicity
  • Terrestrial Ecotoxicology
    • OECD 216 N-Transformation Test (100 days – extension of Tier A study)
    • OECD 208 Terrestrial Plants Growth Test, more species (NOEC)
    • OECD 222 Earthworm Reproduction Test