[...]... 26 Adverse environmental effects and veterinary medicinal products A Tait 17 Adverse effects of veterinary pharmaceutical products in animals K.N Woodward 19 Adverse reactions to vaccines K.N Woodward and L.A Toon 569 529 605 27 Causality in pharmacovigilance and expectedness of adverse reactions K.N Woodward 639 28 Quantitative aspects of veterinary pharmacovigilance K.N Woodward 659 29 Veterinary adverse. .. drug reactions in dogs – toxic hepatic responses K.N Woodward 423 453 20 Adverse reactions in humans following exposure to veterinary drugs 475 K.N Woodward 21 Medicines used to control and treat external parasites of sheep – toxicology and the phenomenon of reported adverse human responses to organophosphorus sheep dips 517 T.C Marrs and P Edwards 22 User safety assessment of veterinary medicinal products. .. pages to even mention the term pharmacovigilance, and none to define it (Bankowski et al., 1999) The European Union’s Directive 2001/82/EC (as amended) requires that: ‘ member states shall establish a veterinary pharmacovigilance system that shall be used to collect information useful in the surveillance of veterinary medicinal products, with 10 Veterinary Pharmacovigilance particular reference to adverse. .. particular, provided a very valuable resource for monitoring adverse reactions In the UK all human SARs are considered by the Appraisal Panel for Human Suspected Adverse Reactions to veterinary medicines, which is a sub-committee of the VPC The Appraisal Panel’s terms of reference are to evaluate all suspected adverse reactions to veterinary medicinal products in humans The Panel plays a key role in identifying... the EU Regulatory Authorities The development of an electronic database in the EU for monitoring pharmacovigilance and adverse reactions is a new development and requires the input of accurate and quality data to enable the production of reliable and valuable information on the adverse reactions to all authorised veterinary medicines A list of clinical terms for reporting suspected adverse reactions in... Ray, D (2004) The Suspected Adverse Reaction Surveillance Scheme – A Report of a Working Group of the Veterinary Products Committee Available at http://www.vpc.gov.uk 1 Elements of veterinary pharmacovigilance K.N Woodward Pharmacovigilance in the human medicines sector is a well-established discipline So well established in fact that reports of adverse reactions to medicinal products are relatively common... been used to control sea lice infestations in salmon and concern over the toxicity of ivermectin led to the development of the less toxic emamectin benzoate All reporting of suspected adverse reactions, other than those reported by the MAH, is voluntary, although there is a professional duty on the veterinary surgeon to report any suspected adverse reaction to the MA holder or to the VMD Veterinary. .. term pharmacovigilance This book is an attempt to survey and summarise current approaches to veterinary pharmacovigilance, to review the types of effects that may be seen and to examine some of the scientific principles involved I hope it will prove useful in academia, in the regulatory environment and within the animal health industry Finally, I should like to pay tribute to one of my contributors,... of the need to report adverse events Sharing of information on adverse reactions is strongly encouraged and a central EU database has been established to allow for electronic reporting This is now obligatory for all MA holders and regulatory authorities within the EU Eudra- 7 Vigilance Veterinary is a central computer database created by the EMEA and contains adverse reaction reports to veterinary medicines... the Veterinary Medicines Directorate (VMD), an executive Agency of the Department for Environment, Food and Rural Affairs 2 Veterinary Pharmacovigilance (DEFRA), is the regulatory authority responsible for pharmacovigilance for veterinary medicines through a national Suspected Adverse Reaction Surveillance Scheme (SARSS) The Scheme records and monitors all reported animal and human suspected adverse reactions . Veterinary Pharmacovigilance Adverse Reactions to Veterinary Medicinal Products Edited by K.N. Woodward A John Wiley & Sons, Ltd., Publication Veterinary. Ltd., Publication Veterinary Pharmacovigilance Veterinary Pharmacovigilance Adverse Reactions to Veterinary Medicinal Products Edited by K.N. Woodward A