Guidelines for Product Information File

  • Indonesia
  • NOMOR 14 2017 PEDOMAN DOKUMEN INFORMASI PRODUK
  • In Force
  • 2017-09-13
  • 2017-09-13
  • Badan Pengawas Obat dan Makanan(BPOM)

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is formulated as some provisions in the Number HK.03.1.23.12.10.12123 Year 2010 on Product Information File are outdated and require updating. As of the date of its implementation the Guidelines for Product Information File is repealed.

This guideline includes the following contents:

  1. Contents in PIF;
  2. Steps for PIF review;
  3. Administrative sanctions for violations;
  4. Transitional clauses, etc.

The complete text of this article is only available to standard/corporate members.Click here to upgrade your membership or know the premium benefits.You are welcome to apply for a 14-day free trail to experience the benefits.