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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.
Last amendments up to Supplementary Provisions (Order of the Ministry of Agriculture, Forestry and Fisheries No. 39 of June 30, 2017).
Title:
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:
Japan
Type of document:
Regulation
Data source:
Files:
Repealed:
No