Chapter 5. Geographical Differences in Market Availability, Regulation and Use of Veterinary Antimicrobial Products

  1. Luca Guardabassi5,
  2. Lars B. Jensen6 and
  3. Hilde Kruse7
  1. Angelo A. Valois1,
  2. Yuuko S. Endoh2,
  3. Kornelia Grein3 and
  4. Linda Tollefson4

Published Online: 30 JAN 2009

DOI: 10.1002/9781444302639.ch5

Guide to Antimicrobial Use in Animals

Guide to Antimicrobial Use in Animals

How to Cite

Valois, A. A., Endoh, Y. S., Grein, K. and Tollefson, L. (2008) Geographical Differences in Market Availability, Regulation and Use of Veterinary Antimicrobial Products, in Guide to Antimicrobial Use in Animals (eds L. Guardabassi, L. B. Jensen and H. Kruse), Blackwell Publishing, Ltd, Oxford, UK. doi: 10.1002/9781444302639.ch5

Editor Information

  1. 5

    Department of Veterinary Pathobiology, Faculty of Life Sciences, University of Copenhagen, Denmark

  2. 6

    National Food Institute, Technical University of Denmark, Copenhagen, Denmark

  3. 7

    Department for Health Surveillance, National Veterinary Institute, Norway

Author Information

  1. 1

    Australian Government Department of Agriculture, Fisheries and Forestry, Canberra, ACT, Australia

  2. 2

    National Veterinary Assay Laboratory, Ministry of Agriculture, Forestry and Fisheries (MAFF), Tokyo, Japan

  3. 3

    European Medicines Agency (EMEA), Canary Wharf, London, UK

  4. 4

    US Food and Drug Administration, Rockville, MD, USA

Publication History

  1. Published Online: 30 JAN 2009
  2. Published Print: 17 APR 2008

ISBN Information

Print ISBN: 9781405150798

Online ISBN: 9781444302639

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Keywords:

  • geographical differences in market availability, regulation and use;
  • APVMA's Manual of Requirements and Guidelines (MORAG);
  • antimicrobial product use in animals and extensive testing prior to marketing;
  • Veterinary medicinal products (VMPs) - ‘veterinary chemical products’ or ‘veterinary drugs’;
  • Ministry of Agriculture, Forestry and Fisheries (MAFF) in Japan - VMPs and antimicrobial agents;
  • food-producing animals and setting maximum residue limits (MRLs);
  • Predicted Environmental No Effect Concentration (PNEC);
  • APVMA Australia - ensures high standards of quality, safety and efficacy;
  • FDA withdrawal time and drug residue depletion below calculated ADI;
  • Recommendations 15–17 of JETACAR - prudent use guidelines and codes of practice

Summary

This chapter contains sections titled:

  • Regulatory authorities and registration principles

  • Data requirements to establish safety and efficacy and assessment principles

  • Assessment of the public health risk associated with antimicrobial resistance

  • Post-marketing monitoring of antimicrobial resistance and drug usage

  • Availability of veterinary antimicrobial products

  • Control of use and off-label use

  • Pharmacovigilance, prudent use guidelines and codes of practice

  • Acknowledgements

  • References