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Volumn , Issue , 2009, Pages 59-76

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

Author keywords

Antimicrobial product use in animals and extensive testing prior to marketing; APVMA australia ensures high standards of quality, safety and efficacy; APVMA's manual of requirements and guidelines (MORAG); FDA withdrawal time and drug residue depletion below calculated ADI; Food producing animals and setting maximum residue limits (MRLs); Geographical differences in market availability, regulation and use; Ministry of agriculture, forestry and fisheries (MAFF) in Japan VMPs and antimicrobial agents; Predicted environmental no effect concentration (PNEC); Recommendations 15 17 of JETACAR prudent use guidelines and codes of practice; Veterinary medicinal products (VMPs) 'veterinary chemical products' or 'veterinary drugs'

Indexed keywords


EID: 77954566996     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781444302639.ch5     Document Type: Chapter
Times cited : (3)

References (43)
  • 1
    • 84889303606 scopus 로고    scopus 로고
    • Australian Pesticides and Veterinary Medicines Authority (APVMA). Manual of Requirements and Guidelines (MORAG). Available at
    • Australian Pesticides and Veterinary Medicines Authority (APVMA). Manual of Requirements and Guidelines (MORAG). Available at: http://www.apvma.gov.au/MORAG_vet/MORAG_vet_home.shtml
  • 2
    • 84889404284 scopus 로고    scopus 로고
    • Australian Pesticides and Veterinary Medicines Authority (APVMA). Part 10, Special Data: Antibiotic Resistance. Available at
    • Australian Pesticides and Veterinary Medicines Authority (APVMA). Part 10, Special Data: Antibiotic Resistance. Available at: http://www.apvma.gov.au/MORAG_vet/vol_3/part_10_antibiotic_resistance.pdf
  • 3
    • 84889300379 scopus 로고    scopus 로고
    • European Parliament and Council, Directive 2001/82/EC of the European Parliament and the Council of 6 November 2001. Off. J. Eur. Comm. L311: 28.11.2004, pp. 01-66, as amended by Directive 2004/28/EC of the European Parliament and the Council of the 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medical products. Off. J. Eur. Comm. L136: 30.04.2004, 58-84. Available at
    • European Parliament and Council (2001). Directive 2001/82/EC of the European Parliament and the Council of 6 November 2001. Off. J. Eur. Comm. L311: 28.11.2004, pp. 01-66, as amended by Directive 2004/28/EC of the European Parliament and the Council of the 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medical products. Off. J. Eur. Comm. L136: 30.04.2004, 58-84. Available at: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev5.htm
    • (2001)
  • 4
    • 84889313583 scopus 로고    scopus 로고
    • European Parliament and Council, Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Off. J. Eur. Comm. L136: 30.4.2004, 1-33. Available at
    • European Parliament and Council (2004). Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Off. J. Eur. Comm. L136: 30.4.2004, 1-33. Available at: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev5.htm
    • (2004)
  • 5
    • 84889318258 scopus 로고    scopus 로고
    • European Parliament and Council, Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition. Off. J. Eur. Comm. L268: 18.10.2003, 29-43. Available at
    • European Parliament and Council (2003). Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition. Off. J. Eur. Comm. L268: 18.10.2003, 29-43. Available at: http://eur-lex.europa.eu/LexUriServ. do?uri=CELEX: 32003R1831:EN:NOT
    • (2003)
  • 6
    • 84889399707 scopus 로고    scopus 로고
    • The Government of Japan. The Pharmaceutical Law. (Law No.145 of 1960)
    • The Government of Japan. The Pharmaceutical Law. (Law No.145 of 1960).
  • 7
    • 84889371258 scopus 로고    scopus 로고
    • The Government of Japan. The Law Concerning Safety Assurance and Quality Improvement of Feed. (Law No.35 of 1953). Available at
    • The Government of Japan. The Law Concerning Safety Assurance and Quality Improvement of Feed. (Law No.35 of 1953). Available at: http://www.famic.go.jp/ffis/feed/obj/sianhou_eng.pdf
  • 8
    • 84889339858 scopus 로고    scopus 로고
    • Food and Agricultural Materials Inspection Center (FAMIC). List of Feed Additives. Available at
    • Food and Agricultural Materials Inspection Center (FAMIC). List of Feed Additives. Available at: http://www. famic.go.jp/ffis/feed/sub3_feedadditives_en.html
  • 9
    • 84889314624 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration. Available at, accessed: November 23, 2007
    • U.S. Food and Drug Administration. Available at: www. fda.gov/cvm.Last accessed: November 23, 2007.
  • 10
    • 84889450962 scopus 로고    scopus 로고
    • VICH. VICH Guidelines. Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. Available at, Last accessed November 23, 2007
    • VICH. VICH Guidelines. Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. Available at: http://www.vichsec.org/index.htm. Last accessed November 23, 2007.
  • 11
    • 84889283326 scopus 로고    scopus 로고
    • EMEA. Veterinary Medicinal Products. European Medicines Agency, London. Available at
    • EMEA. Veterinary Medicinal Products. European Medicines Agency, London. Available at: http://www. emea.europa.eu/index/indexv1.htm; http://www.emea. europa.eu/htms/vet/vetguidelines/background.htm
  • 12
    • 84889293729 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration, Center for Veterinary Medicine. Information and requirements for review and approval. Available at, Last accessed: November 23, 2007
    • U.S. Food and Drug Administration, Center for Veterinary Medicine. Information and requirements for review and approval. Available at: www.fda.gov/cvm/nadaappr.htm. Last accessed: November 23, 2007.
  • 13
    • 84889426641 scopus 로고    scopus 로고
    • EMEA. Guideline for the demonstration of efficacy for veterinary medicinal use containing antimicrobials, EMEA/CVMP/627/01. European Medicines Agency, London. Available at
    • EMEA (2002). Guideline for the demonstration of efficacy for veterinary medicinal use containing antimicrobials. EMEA/CVMP/627/01. European Medicines Agency, London. Available at: http://www.emea.europa.eu/pdfs/vet/ewp/062701en.pdf
    • (2002)
  • 14
    • 84889357049 scopus 로고    scopus 로고
    • EMEA. Guidelines for the conduct of efficacy studies for intramammary products for use in cattle, EMEA/CVMP/344/99. European Medicines Agency, London. Available at
    • EMEA (1999). Guidelines for the conduct of efficacy studies for intramammary products for use in cattle. EMEA/CVMP/344/99. European Medicines Agency, London. Available at: http://www.emea.europa.eu/pdfs/vet/ewp/034499en.pdf
    • (1999)
  • 15
    • 84889300919 scopus 로고
    • European Council. Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits for veterinary medicinal products in foodstuffs of animal origin, Off. J. Eur. Comm. L224: 18.8.90, 1-8. Available at
    • European Council (1990). Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits for veterinary medicinal products in foodstuffs of animal origin. Off. J. Eur. Comm. L224: 18.8.90, 1-8. Available at: http://ec.europa.eu/enterprise/pharmaceuticals/mrl/conspdf/01990r237720050711--en.pdf
    • (1990)
  • 17
    • 84889336702 scopus 로고    scopus 로고
    • OIE. Terrestrial animal health code, World Organisation for Animal Health, Paris. Available at
    • OIE (2006). Terrestrial animal health code. World Organisation for Animal Health, Paris. Available at: http://www.oie.int/eng/normes/mcode/en_chapitre_3.9.3.htm
    • (2006)
  • 18
    • 84889457244 scopus 로고    scopus 로고
    • Codex Alimentarius Commission, ALINORM 05/28/31, Appendix VIII. Available at, Last accessed: November 23, 2007
    • Codex Alimentarius Commission (2006). ALINORM 05/28/31, Appendix VIII. Available at: http://www. codexalimentarius.net/web/index_en.jsp. Last accessed: November 23, 2007.
    • (2006)
  • 19
    • 84889463074 scopus 로고    scopus 로고
    • Joint Expert Technical Advisory Committee on Antibiotic Resistance (JETACAR). The use of antibiotics in food-producing animals: antibiotic-resistant bacteria in animals and humans, Commonwealth Departments of Health and Aged Care, and Agriculture, Fisheries and Forestry, Canberra Australia
    • Joint Expert Technical Advisory Committee on Antibiotic Resistance (JETACAR) (1999). The use of antibiotics in food-producing animals: antibiotic-resistant bacteria in animals and humans. Commonwealth Departments of Health and Aged Care, and Agriculture, Fisheries and Forestry, Canberra Australia. Available at: http://www.health.gov. au/internet/wcms/publishing.nsf/content/health-pubsjetacar-cnt.htm/$FILE/jetacar.pdf
    • (1999)
  • 20
    • 84889320840 scopus 로고    scopus 로고
    • The Commonwealth Government Response to the Report of the Joint Expert Technical Advisory Committee on Antibiotic Resistance (JETACAR), Commonwealth Departments of Health and Aged Care, and Agriculture, Fisheries and Forestry, Canberra Australia
    • The Commonwealth Government Response to the Report of the Joint Expert Technical Advisory Committee on Antibiotic Resistance (JETACAR) (2000). Commonwealth Departments of Health and Aged Care, and Agriculture, Fisheries and Forestry, Canberra Australia. Available at: http://www.health.gov.au/internet/wcms.publishing.nsf/content/health-pubhlth-publicat-document-jetacar-cnt. htm/$FILE/jetacar.pdf
    • (2000)
  • 21
    • 84889313603 scopus 로고    scopus 로고
    • Australian Government National Health and Medical Research Council. Available at
    • Australian Government National Health and Medical Research Council. Available at: http://www.nhmrc.gov.au/about/committees/expert/eagar/_files/antirate.pdf
  • 22
    • 84889344975 scopus 로고    scopus 로고
    • EMEA. Revised guideline on the SPC for antimicrobial products, EMEA/CVMP/SAGAM/38344/2005. European Medicines Agency, London. Available at
    • EMEA (2007). Revised guideline on the SPC for antimicrobial products. EMEA/CVMP/SAGAM/38344/2005. European Medicines Agency, London. Available at: http://www.emea.europa.eu/pdfs/vet/sagam/3834410.enfin.pdf
    • (2007)
  • 23
    • 84889460072 scopus 로고    scopus 로고
    • EMEA. Public statement on the use of (Fluoro) quinolones in food-producing animals in the European Union: development of resistance and impact on the human and animal health, EMEA/CVMP/SAGAM/184651/2005. European Medicines Agency, London. Available at
    • EMEA (2007). Public statement on the use of (Fluoro) quinolones in food-producing animals in the European Union: development of resistance and impact on the human and animal health. EMEA/CVMP/SAGAM/184651/2005. European Medicines Agency, London. Available at: http://www.emea.europa.eu/pdfs/vet/srwp/18465106en.pdf
    • (2007)
  • 24
    • 84889294009 scopus 로고    scopus 로고
    • EMEA. CVMP strategy on antimicrobials for 2006-2010 and status report on activities on antimicrobials, EMEA/CVMP/353297/2005. European Medicines Agency, London. Available at
    • EMEA (2006). CVMP strategy on antimicrobials for 2006-2010 and status report on activities on antimicrobials. EMEA/CVMP/353297/2005. European Medicines Agency, London. Available at: http://www.emea.europa.eu/pdfs/vet/swp/35329705.pdf
    • (2006)
  • 25
    • 84889303320 scopus 로고    scopus 로고
    • The Government of Japan. The Food Safety Basic Law. (Law No. 48 of 2003). Available at
    • The Government of Japan. The Food Safety Basic Law. (Law No. 48 of 2003). Available at: http://www.fsc.go.jp/sonota/fsb_law1807.pdf
  • 26
    • 84889417371 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration, Center for Veterinary Medicine. (2003). Guidance for Industry #152: Evaluating the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern. Available at
    • U.S. Food and Drug Administration, Center for Veterinary Medicine. (2003). Guidance for Industry #152: Evaluating the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern. Available at: www.fda.gov/cvm/Guidance/fguide152.DOC.
  • 27
    • 84889313126 scopus 로고    scopus 로고
    • Australian Pesticides and Veterinary Medicines Authority (APVMA). Available at
    • Australian Pesticides and Veterinary Medicines Authority (APVMA). Available at: http://www.apvma.gov.au/registration/downloads/antibiotics_1999_2002.pdf
  • 28
    • 84889415373 scopus 로고    scopus 로고
    • EMEA. Antibiotic resistance in the European Union associated with therapeutic use of veterinary medicines: report and qualitative risk assessment by the Committee for Veterinary Medicinal Products, EMEA/CVMP/342/99. European Medicines Agency, London. Available at
    • EMEA (1999). Antibiotic resistance in the European Union associated with therapeutic use of veterinary medicines: report and qualitative risk assessment by the Committee for Veterinary Medicinal Products. EMEA/CVMP/342/99. European Medicines Agency, London. Available at: http://www.emea.europa.eu/pdfs/vet/regaffair/034299en.pdf
    • (1999)
  • 29
    • 84889444478 scopus 로고    scopus 로고
    • European Parliament and Council, Directive 2003/99/EC of the European Parliament and of the Council, of 17 November 2003 on the monitoring of oonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC. Off. J. Eur. Comm. L325: 12.12.2003, 31-40. Available at
    • European Parliament and Council (2003). Directive 2003/99/EC of the European Parliament and of the Council, of 17 November 2003 on the monitoring of oonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC. Off. J. Eur. Comm. L325: 12.12.2003, 31-40. Available at: http://eur_lex.europa.eu/LexWriServ. do?uri=CELEX:32003L0099:EN:NOT
    • (2003)
  • 30
    • 84889311385 scopus 로고    scopus 로고
    • EFSA. The community summary reports on trends and sources of zoonoses, zoonotic agents and antimicrobial resistance in the European Union in 2004 and 2005, European Food Safety Authority, Parma. Available at
    • EFSA (2006). The community summary reports on trends and sources of zoonoses, zoonotic agents and antimicrobial resistance in the European Union in 2004 and 2005. European Food Safety Authority, Parma. Available at: http://www.efsa.europa.eu/en/science/monitoring_ zoonoses/reports.html
    • (2006)
  • 31
    • 84889375720 scopus 로고    scopus 로고
    • The National Veterinary Assay Laboratory, MAFF (NVAL). Available at
    • The National Veterinary Assay Laboratory, MAFF (NVAL). Available at: http://www.nval.go.jp/taisei/etaisei/JVARM (text%20and%20Fig)%Final.htm
  • 32
    • 84889308188 scopus 로고
    • Institute of Medicine, Committee on Human Health Risk Assessment of Using Subtherapeutic Antibiotics in Animal Feeds. Human health risks with the subtherapeutic use of penicillin or tetracyclines in animal feed, National Academy Press, Washington, DC
    • Institute of Medicine, Committee on Human Health Risk Assessment of Using Subtherapeutic Antibiotics in Animal Feeds (1989). Human health risks with the subtherapeutic use of penicillin or tetracyclines in animal feed. National Academy Press, Washington, DC.
    • (1989)
  • 33
    • 84889293544 scopus 로고    scopus 로고
    • National Antimicrobial Resistance Monitoring System. Available at
    • National Antimicrobial Resistance Monitoring System. Available at: http://fda.gov/cvm/narms_pg.html
  • 34
    • 84889386064 scopus 로고    scopus 로고
    • Australian Pesticides and Veterinary Medicines Authority (APVMA)
    • Australian Pesticides and Veterinary Medicines Authority (APVMA). Available at: http://services.apvma.gov.au/PubcrisWebClient/welcome.do
  • 35
    • 84889421918 scopus 로고    scopus 로고
    • The Heads of Medicines Agencies website
    • The Heads of Medicines Agencies website. Available at: http://www.hma.eu/
  • 36
    • 84889394530 scopus 로고    scopus 로고
    • The Government of Japan. The Food Sanitation Law. (Law No.233 of 1947)
    • The Government of Japan. The Food Sanitation Law. (Law No.233 of 1947). Available at: http://www.jetro.go.jp/en/market/regulations/pdf/food-e.pdf
  • 37
    • 84889404382 scopus 로고    scopus 로고
    • Australian Chicken Meat Federation and the Australian Egg Industry Association
    • Australian Chicken Meat Federation and the Australian Egg Industry Association. Available at: http://www.jcu. edu.au/school/bms/avpa/code_of_prac_jul_2001.pdf
  • 38
    • 84889292559 scopus 로고    scopus 로고
    • Australian Veterinary Association (AVA). Use of antimicrobial drugs in veterinary practice, 1999; Safe use of veterinary medicines on farms, 1997; Code of practice for the use of prescription animal remedies (schedule 4 substances) in the pig industry, 1997; and Code of practice for the use of prescription animal remedies (schedule 4 substances) in the poultry industry, 2001)
    • Australian Veterinary Association (AVA). Use of antimicrobial drugs in veterinary practice, 1999; Safe use of veterinary medicines on farms, 1997; Code of practice for the use of prescription animal remedies (schedule 4 substances) in the pig industry, 1997; and Code of practice for the use of prescription animal remedies (schedule 4 substances) in the poultry industry, 2001). Available at: http://www.ava.com.au
  • 39
    • 84889461918 scopus 로고    scopus 로고
    • Australian Pork Limited Technical Notes
    • Australian Pork Limited Technical Notes. Available at: http://www.australianpork.com.au/index.cfm?menuid= D912DD189027-E5331-F749DF794A6BC9E
  • 40
    • 84889496734 scopus 로고    scopus 로고
    • FVE Antibiotic Resistance and Prudent Use of Antibiotics in Veterinary Medicine. Federation of Veterinarians in Europe, Brussels.
    • FVE Antibiotic Resistance and Prudent Use of Antibiotics in Veterinary Medicine. Federation of Veterinarians in Europe, Brussels. Available at: http://fve.org/papers/pdf/vetmed/position_papers/antibioen.pdf
  • 41
    • 84889302808 scopus 로고    scopus 로고
    • RUMA. Guidelines for the 'Responsible Use of Antimicrobials' in poultry, pigs, cattle, sheep and fish. Responsible Use of Medicines in Agriculture Alliance, Welwyn, UK
    • RUMA (2004). Guidelines for the 'Responsible Use of Antimicrobials' in poultry, pigs, cattle, sheep and fish. Responsible Use of Medicines in Agriculture Alliance, Welwyn, UK. Available at: http://www.ruma.org.uk/
    • (2004)
  • 42
    • 84889492627 scopus 로고    scopus 로고
    • NVAL
    • NVAL. Available at: http://www.nval.go.jp/taisei/oie/OIEguide2.htm
  • 43
    • 84889406831 scopus 로고    scopus 로고
    • The American Veterinary Medical Association (AVMA) guidelines
    • The American Veterinary Medical Association (AVMA) guidelines. Available at: www.avma.org/reference/defalut.asp


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