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

Country/Territory
Japan
Document type
Regulation
Date
2004 (2017)
Source
FAO, FAOLEX
Subject
Livestock, Fisheries
Keyword
Drugs Fish disease Fishery management and conservation Registration Capacity building Certification Internal trade International trade Animal health Pests/diseases
Geographical area
Asia, Asia and the Pacific, Eastern Asia, North Pacific, North-West Pacific
Abstract

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.

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

Implemented by

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

Legislation | Japan | 1994 (2014)

Keyword: Monitoring, Drugs, Fish disease, Fishery management and conservation, Internal trade, International trade, Animal health, Pests/diseases

Source: FAO, FAOLEX