Veterinary pharmacovigilance. Part 1. The legal basis in the European Union.
J Vet Pharmacol Ther
; 28(2): 131-47, 2005 Apr.
Article
em En
| MEDLINE
| ID: mdl-15842304
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.
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Base de dados:
MEDLINE
Assunto principal:
Vigilância de Produtos Comercializados
/
Guias como Assunto
/
Drogas Veterinárias
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Indústria Farmacêutica
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Legislação de Medicamentos
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Legislação Veterinária
Idioma:
En
Ano de publicação:
2005
Tipo de documento:
Article