v. 28 – Q4 2023

Minor Update: e-leaflet pilot announced

Market Executive Summary Requirement defined by National Agency of Drug and Food Control of Republic of Indonesia – Kepala Badan Pengawas Obat dan Makanan (BPOM): Proprietary or GS1 (currently choice for 2D or QR data carrier) with Aggregation and Government Database reporting (Pre-Packaging and Post-marketing reporting), to be implemented accordingb to phased timeline.

Indonesia regulation impose different methods depending on product class. Identification Method (Static Info) or Authentication Method (Serialisation and aggregation) are to be implemented depending on Product Class.

BPOM issued regulation No. 22/2022 implementation of 2D barcode in Drug and Food Monitoring on Track & Trace in Indonesia (effective date 5 Oct. 2022) as a replacement for Regulation of the National Agency of Drug and Food Control Number 33 of 2018. Regulation 22 (2018) will be revoked and declared as null and voided, when Regulation 22 (2022) comes into force.

Key Dates
  • December 7, 2025/2027: Authentication method – Traceability
  • December 7, 2023: Identification method – Data standard/labelling
  • September 2022: POM Agency Regulation No. 22 of 2022 issued
  • June 2021: Authentication method – Traceability
  • June 2019: Identification method – Data standard/labelling
  • December 2018: POM Agency Regulation No. 33 of 2018 issued

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