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Regulatory Rules for Veterinary Medicinal Products, Ordinance of the Ministry of Agriculture, Forestry and Fisheries No. 107, 2004.

País/Territorio
Japón
Tipo de documento
Reglamento
Fecha
2004 (2017)
Fuente
FAO, FAOLEX
Materia
Ganado, Pesca
Palabra clave
Medicamentos Enfermedades de los peces Manejo y conservación pesquera Registro Fortalecimiento de la capacidad Certificación Comercio interior Comercio internacional Sanidad animal Plagas/enfermedades
Área geográphica
Asia, Asia y Pacifico, Asia Oriental, Pacífico Norte, Pacífico Nordoeste
Resumen

These Regulatory Rules, consisting of 214 articles, establish all matters related to Marketing Business and Manufacturing Industry of Medicinal products and Quasi-drug. Applications for license under the stipulations in the Act, Article 12, Paragraph 1 shall be made by submitting an application form prescribed in Appended Form No. 1 with specific documents listed in the items to the Minister of Agriculture, Forestry and Fisheries. The format of the certificate of license stipulated in the Act Enforcement Ordinance on securing quality, efficacy and safety of products including pharmaceuticals and medical devices. Marketing authorization holders of medicinal products (excluding in vitro diagnostic) or quasi-drug shall display the certificate of license issued as stipulated in the Ordinance. It also regulates antimicrobial substance preparations as medical products that contain antibiotics.

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

Implementado por

Ministerial Ordinance Concerning Manufacturing Control and Quality Control of Veterinary Medicinal Products No. 18, 1994.

Legislación | Japón | 1994 (2014)

Palabra clave: Monitoreo, Medicamentos, Enfermedades de los peces, Manejo y conservación pesquera, Comercio interior, Comercio internacional, Sanidad animal, Plagas/enfermedades

Fuente: FAO, FAOLEX