Guidelines for Product Information File

  • Indonesia
  • 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. Year 2010 on Product Information File are outdated and require updating. As of the date of its implementation the Guidelines for Product Information File is repealed.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.

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