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Guide to Factory Installation Procedures

Pharmaceutical Affairs Act, Veterinary Medicine, etc. Regulations

Followings are applicable when procedures based on laws or ordinances, etc. are required.
Name of laws and regulations Pharmaceutical Affairs Act, Veterinary Medicine, etc. Regulations
When
(The timing of procedures)		 Prior to the manufacturing and marketing of veterinary medicine, etc.
Who
(Procedure Targets)		 Those who intend manufacturing & marketing of veterinary medicine, veterinary quasi-drugs, and veterinary medical equipment.
What
(Documents)
1. Operation Permission Application documents
2. Permission application documents for manufacturing and marketing of veterinary medicine, etc.
・Veterinary Medicine, Veterinary Quasi-drugs, and Veterinary Medical Equipment Manufacturing and Marketing Operation Permission Application.
・Veterinary Medicine, Veterinary Quasi-drugs, and Veterinary Medical Equipment Manufacturing and Marketing Operation Permission Application.
 >> Outside Link
（within the website of the Ministry of Agriculture, Forestry and Fishery）
・Veterinary Medicine for In vitro Diagnosis Manufacturing and Marketing Permission Application.
・Veterinary Medical Equipment Manufacturing and Marketing Permission Application.		 >>Outside Link
（within the website of the Inspection Offfice of Veterinary Medicines）
Download file is Word2002SP3/for Win format.
If unable to download, please inquire to"Contact for Inquiries".
Where
(Procedure Office)		 Tochigi Prefecture (Livestock Hygiene Center)
　　※Manufacturing and Marketing Permission Application shall be submitted directly to the relevant ministry.
How
(Examination Contents)
Contents in accordance with the Pharmaceutical Affairs Act.
Flow of Procedures
Processing Period （Standard Processing Period）
1. Operation Permission Application
　　　　　　　　　Authorization by the Minister of Agriculture, Forestry and Fisheries: 6 months.
2. Permission Application
　　　　　　　　　Authorization by the Minister of Agriculture, Forestry and Fisheries.
　　　　　　　　　Veterinary Medicine: 12 months.
　　　　　　　　　Veterinary Quasi-drugs;: 10 months.
　　　　　　　　　Veterinary Medical Equipment: 12 months (New Medical Equipment). 6 months (Generic drugs) 　　　　　　　　　　　　　　　　　　　　　
Contact for Inquiries
Tochigi Prefecture Department of Industry, Labor and Tourism, International Section　
TEL: 028-623-2194　
FAX: 028-623-2199

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