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Guidelines for Product Information File (Draft for Comments)
Local Title:
NOMOR .... TAHUN 2022 TENTANG PEDOMAN DOKUMEN INFORMASI PRODUK
Country/Region:
Indonesia
Competent Authority:
Badan Pengawas Obat dan Makanan
Type:
Regulation
Status:
Draft
Release Date:
2022-10-31
Implementation Date:
/
Document
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 Official Guidelines for Product Information File (Draft for Comments)
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Summary

On Oct. 31, 2022, Indonesia Food and Drug Supervisory Agency (BPOM) released the draft of the Guidelines for Product Information File (PIF) for public consultation. The draft is divided into 3 chapters and 16 articles with 1 appendix, which stipulates the documents requirements, language requirements, retention time, retention form, PIF review method, etc. The aim of this draft is to guide cosmetic companies in preparing and compiling PIF, and guide BPOM officials to review PIF.

Main Content

  • General Requirements

  • Product Information File Guidelines

  • Product Information File Audit

  • Administrative Sanctions

  • 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