Veterinary pharmacovigilance. Part 1. The legal basis in the European Union

Abstract

Pharmacovigilance is a growing discipline and nowhere is this more true than in the context of the legislative requirements for veterinary pharmacovigilance within the European Union (EU), or more specifically, within the European Economic Area. Since 1995, the legislation governing the authorization of veterinary medicinal products in the EU has resulted in the older national procedures being replaced by the mutual recognition procedure and the centralized procedure. Also since 1995, the regulatory requirements for pharmacovigilance have developed and grown, as have the associated guidelines. The recent review of European veterinary medicines legislation, which concluded with the publication of an amending directive and a new regulation in March 2004, has introduced refinements to the pharmacovigilance system. This paper examines the EU legislation governing the authorization of veterinary medicinal products, including the elaboration of maximum residue limits, and the way in which this relates to the requirements of pharmacovigilance.

Veterinary pharmacovigilance. Part 6. Predictability of adverse reactions in animals from laboratory toxicology studies

“…Hence, comparisons are difficult, and where information is available from regulatory authorities, it is often too brief to be used for purposes of analytical study. Exceptions to this are the reports and toxicology monographs published by the Joint FAO/WHO Expert Committee on Food Additives (see Woodward, 2005, pp. 131–147 of this issue).…”

Veterinary pharmacovigilance. Part 2. Veterinary pharmacovigilance in practice – the operation of a spontaneous reporting scheme in a European Union country – the UK, and schemes in other countries

“…Hence, the authors considered that the assessments lacked legitimacy (Montforts & de Knecht, 2002). However, representatives of the authorities responded robustly pointing out that the environmental assessments of veterinary medicines is part of the regulatory and authorization processes, and that harmonization is being achieved through VICH (see Woodward, 2005) in a process that is open to public consultation (Long & Crane, 2002).…”

Pharmacovigilance in veterinary medicine in Chile: a pilot study

“…Adverse drug reactions (ADRs) are harmful, unintended reactions often occurring at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or the modification of physiological function (Woodward, 2005; European Union, 2008). According to the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), ADRs are ‘events whether or not considered to be product‐related that is unfavourable and unintended and that occurs after any use of a veterinary medicinal product (VMP) (on‐label or off‐label uses).…”