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Guide to Factory Installation Procedures

Pharmaceutical Affairs Act

Followings are applicable when procedures based on laws or ordinances, etc. are required.
Name of laws and regulations Pharmaceutical Affairs Act
(The timing of procedures)
Please make a prior contact to Tochigi Prefecture Pharmaceutical Affairs Section Regulatory Affairs Examination in charge.
(Procedure Targets)
Those who intend manufacturing and marketing (including import marketing) or manufacturing (including packaging, labeling and storing) of pharmaceuticals, quasi-drugs, cosmetics, or medical equipment, or repairing of medical equipment.
1. Operation Permission Application documents.
2. Operation permission notification documents.
・Pharmaceuticals, quasi-drugs, cosmetics, or medical equipment manufacturing permission application or modification application.
・Medical equipment repair service permission application or modification application.
FD Application Website
(Procedure Office)
Tochigi Prefecture
(Examination Contents)
Contents in accordance with the Pharmaceutical Affairs Act.
Flow of Procedures
Processing Period (Standard Processing Period)
Operation Permission Application
        Authorization by the Governor: 60 days.
        Authorization by the Minister:
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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