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

Country/Territory
Japan
Document type
Regulation
Date
1997 (2014)
Source
FAO, FAOLEX
Subject
Livestock, Fisheries
Keyword
Standards Research Monitoring Drugs Fish disease Animal health Pests/diseases
Geographical area
Asia, Asia and the Pacific, Eastern Asia, North Pacific, North-West Pacific
Entry into force notes
This Ministerial Ordinance enters into force on 1 November 1999.
Abstract

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.

Full text
Japanese/English
Website
www.maff.go.jp

References - Legislation

Implements

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

Legislation | Japan | 1960 (2015)

Keyword: Pesticides, Registration, Residues, Toxicity/poisoning, Offences/penalties, Public health, Internal trade, International trade, Food quality control/food safety, Agricultural development, Drugs, Animal health, Biological control agents, Soil pollution/quality

Source: FAO, FAOLEX