Guidelines for Product Information File
Local Title:
NOMOR 14 2017 PEDOMAN DOKUMEN INFORMASI PRODUK
Country/Region:
Indonesia
Status:
In force
Type:
Regulation
Release Date:
2017-09-11
Implementation Date:
2017-09-13
Competent Authority:
Badan Pengawas Obat dan Makanan
Document:
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is formulated as some provisions in the Number HK.03.1.23.12.10.12123 Year 2010 on Product Information File are outdated and require updating. As of the date of its implementation the Guidelines for Product Information File is repealed.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

Details
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