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Guidelines for Product Information File
Local Title:
NOMOR 14 2017 PEDOMAN DOKUMEN INFORMASI PRODUK
Country/Region:
Indonesia
Competent Authority:
Badan Pengawas Obat dan Makanan
Type:
Regulation
Status:
Invalid
Release Date:
2017-09-11
Implementation Date:
2017-09-13
Document
Language Source Title Access
ID
 Official Guidelines for Product Information File
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Guidelines for Product Information File
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Summary

The regulation is formulated as some provisions in the Number HK.03.1.23.12.10.12123 Year 2010 on Product Information File are outdated and require updating. As of the date of its implementation the Guidelines for Product Information File is repealed.

Main Content

  • General Requirements

  • Product Information File Guidelines

  • Product Information File Audit

  • Administrative Sanctions

  • Transitional Provisions

  • Closing

  • Attachment Product Information File Guidelines



History
2023-08-02
Guidelines for Product Information File
In force
Release Date: 2023-08-02
Implementation Date : 2023-08-02
2022-10-31
Guidelines for Product Information File (Draft for Comments)
Draft
Release Date: 2022-10-31
Implementation Date : /
2017-09-11
Guidelines for Product Information File
Invalid
Release Date: 2017-09-11
Implementation Date : 2017-09-13
Noteworthy Information