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Ministerial Ordinance on Standards for Non-Clinical Studies Concerning Safety of Veterinary Medicinal Products No. 74, 1997.

País/Territorio
Japón
Tipo de documento
Reglamento
Fecha
1997 (2014)
Fuente
FAO, FAOLEX
Materia
Ganado, Pesca
Palabra clave
Normas Investigación Monitoreo Medicamentos Enfermedades de los peces Sanidad animal Plagas/enfermedades
Área geográphica
Asia, Asia y Pacifico, Asia Oriental, Pacífico Norte, Pacífico Nordoeste
Entry into force notes
This Ministerial Ordinance enters into force on 1 November 1999.
Resumen

This Ministerial Ordinance on Standards for Non-Clinical Studies Concerning Safety of Veterinary Medicinal Products is established in accordance with the provisions in the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, Article 83, Paragraph 1. It establishes items relating to non-clinical tests (limited to those that are performed using test systems in test facilities for collecting and preparing data relating to acute toxicity, sub-acute toxicity, chronic toxicity, teratogenicity, as well as other toxicity, and residual effects (referring to properties that cause substances (including those substances that were formed through chemical changes) which are components of veterinary medicinal products to remain in the animals (including items produced such as milk and eggs) following the use of those products), from among the data prescribed in Regulations for Veterinary Medicinal Products (2004 Ordinance of the Ministry of Agriculture, Forestry and Fisheries No. 107.

Texto completo
Inglés/Japonés
Página web
www.maff.go.jp

Referencias - Legislación

Implementa

Law No. 145 on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices.

Legislación | Japón | 1960 (2015)

Palabra clave: Plaguicidas, Registro, Residuos, Toxicidad/envenenamiento, Infracciones/sanciones, Salud pública, Comercio interior, Comercio internacional, Control de calidad de los alimentos/inocuidad de los alimentos, Desarrollo agrícola, Medicamentos, Sanidad animal, Agentes de control biológico, Contaminación del suelo/calidad

Fuente: FAO, FAOLEX