Cosmetic Compliance
Intelligence & Solutions
Submission Documents for Application of GMP Compliance Inspection
Local Title:
医薬品等適合性調査の申請に当たって提出すべき資料について
Country/Region:
Japan
Competent Authority:
Pharmaceuticals and Medical Devices Agency
Type:
Regulation
Status:
In force
Release Date:
2019-06-17
Implementation Date:
2019-06-17
Document
Language Source Title Access
JA
Official submission_documents_for_application_of_gmp_compliance_inspection.pdf
JA
Official annex_1.pdf
JA
Official annex_2.pdf
JA
Official annex_3.doc
JA
Official annex_4.doc
JA
Official annex_5.doc
JA
Official form_1.doc
JA
Official form_2.doc
JA
Official form_3.doc
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Submission Documents for Application of GMP Compliance Inspection
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Summary

The regulation specifies the application methods, required documents and detailed requirements for the documents.

Noteworthy Information