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Ministerial Order to Specify Cases to be Exempted from the Application of the Provisions Concerning the Prohibition of Use of Pharmaceuticals and Regenerative Medicine Products under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Order No. 70, 2003).

Country/Territory
Japan
Document type
Regulation
Date
2003 (2017)
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Enforcement/compliance Animal health Certification International trade Pests/diseases Quarantine Drugs Use restrictions
Geographical area
Asia, Asia and the Pacific, Eastern Asia, North Pacific, North-West Pacific
Entry into force notes
This Ministerial Order enters into force on 30 July 2003.
Abstract

Based on the provisions of Article 83-3 of the Pharmaceutical Affairs Act (Act No. 145 of 1960), this Ministerial Order specifies cases to be Exempted from the Application of the Provisions Concerning the Prohibition of Use of Pharmaceuticals under the Pharmaceutical Affairs Act. Cases to be Exempted from the application are as follows: (i) cases where pharmaceuticals are indicated; or regenerative medicine products are indicated and used on the animals concerned (prescribed in Article 14, paragraph (2), item (iii), (b) of the Act as applied pursuant to Article 83, paragraph (1) of the Act following the deemed replacement of terms; for research purposes; (ii) cases where veterinarians use pharmaceuticals (excluding those containing the substances listed in the Appended Table as their active components or regenerative medicine products on the animals concerned to which the veterinarians provide medical care for the purpose of medical practices of diagnosis, treatment or prevention of diseases thereof; (iii) cases where owners of the animals concerned use pharmaceuticals or regenerative medicine products prescribed by the veterinarians; (iv) cases where animal health inspectors or quarantine officers use biological preparations or regenerative medicine products produced or imported by the national government or prefectures.

Full text
English
Website
www.maff.go.jp