Pharmaceutical Affairs Act

Followings are applicable when procedures based on laws or ordinances, etc. are required.

Name of laws and regulations

Pharmaceutical Affairs Act

When
(The timing of procedures)

Please make a prior contact to Tochigi Prefecture Pharmaceutical Affairs Section Regulatory Affairs Examination in charge.

Who
(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.

What
(Documents)

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.

Where
(Procedure Office)

Tochigi Prefecture

How
(Examination Contents)

Contents in accordance with the Pharmaceutical Affairs Act.

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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