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Ministerial Ordinance on Standards for Post-Marketing Surveillance and Testing of Veterinary Medical Products No. 33, 2005.

País/Territorio
Japón
Tipo de documento
Reglamento
Fecha
2005 (2016)
Fuente
FAO, FAOLEX
Materia
Ganado, Pesca
Palabra clave
Inspección Monitoreo Medicamentos Enfermedades de los peces Manejo y conservación pesquera Comercio interior Comercio internacional Sanidad animal Plagas/enfermedades
Área geográphica
Asia, Asia y Pacifico, Asia Oriental, Pacífico Norte, Pacífico Nordoeste
Resumen

This Ministerial Ordinance, consisting of 10 articles, shall be read as applied pursuant to the provisions of Article 83, paragraph 1 of the Act on Ensuring Quality, Effectiveness and Safety of Pharmaceuticals, Medical Devices. This Ordinance prescribes by the reference survey post-marketing and those related to the test (excluding those stipulated in the Ministerial Ordinance on Standards for Implementation of Clinical Trials for Veterinary Drugs, Ministry Ordinance No. 75 of the Ministry of Agriculture, Forestry and Fisheries in 1997). The matters to be determined aim at defining "post-marketing surveillance", meaning a manufacturer or distributor of a pharmaceutical product that is intended exclusively for animals or use-results survey or post-marketing clinical trial conducted by a person who has obtained a special approval for foreign manufactured drugs, etc. (as defined in paragraph 4). In order to carry out post-marketing surveillance, manufacturers and distributors must prepare a business procedure manual for post-marketing surveillance that describes specific procedures. The following matters shall be stipulated in the usage-results survey implementation plan: 1. purpose of the investigation; 2. number of facilities and the number of cases scheduled for investigation; 3. animals to be surveyed; 4. survey methods; 5. survey periods; 6. items to be investigated; 7 items and methods for analysis; 8. other necessary items.

Texto completo
Japonés
Página web
elaws.e-gov.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