Pharma

Pharma serialization
in Indonesia

Regulator
National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan) BPOM
System
Traceability
Incomplete
Branding
Medicines, depending on the type, must have one of 2 types of code:
  1. Authentication code – GS1 2D Data Matrix: standard GTIN – 14 digits, Serial Number – 13 digits
  2. Identification code – QR code containing information: Registration Certificate number and NIE Number (license number issued by BPOM)
In case two 2D Barcodes are printed on the drug package one of them, that issued by BPOM, is required to has prefix “BPOM RI”
What is required
to start serialization:
What is required
to start serialization:
List of local abbreviations
  • TTAC System – Track and Trace, Anti Counterfeit control product System
  • BPOM - Badan Pengawas Obat dan Makanan - National Agency of Drug and Food Control
  • NIE - license number issued by BPOM
Further development timeline
  • 2017-2023 - identification barcodes (QR) on all products
  • Until 2025 - authentication barcodes (DataMatrix) on all products subject to serialization
Pharma serialization in Indonesia
Order of the DataMatrix codes
The manufacturer orders unique QR codes no later than 10 working days before the start of production of the series by submitting an electronic application via TTAC.
The codes will be issued by BPOM no later than 5 working days after the application is submitted.
1
Utilization of DataMatrix codes
Upon application of the codes, the manufacturer sends to the system a report on the change in the status of the codes for activated codes, rejected codes and retained samples.
2
Aggregation
Items can be aggregated into factory or transport packages that are stacked in pallets. The aggregation process complies with the GS1 standard. Aggregation must be reporting sequentially in one process, namely the primary code which corresponds to the secondary code, and the secondary code which related to the tertiary code.
3
Dispatch to a new owner
When dispatching to the counterparty, the participant sends a report to the system containing the shipped codes and the recipient to the address where the shipment is carried out. The codes change the status to dispatched. Upon receipt of the shipment, the counterparty sends a report on the receipt of products to the system. The codes change their status to accepted.
4
Withdrawal from circulation
Upon the sale of serialized packaging in a pharmacy to the end user, the institution sends a report to the system. The codes change their status to Withdrawn.
5
Return of the product
During the turnover of medicines, situations may arise when the products are returned to the participant of the turnover who previously shipped them. Participant 1 sends a report on the return of products to Participant 2 to the system, about which they will receive a notification in the system and by email. Participant 2 conducts an inspection of the returned products and accepts the refund or rejects it, about that Participant 1 will receive a notification from the system.
6
Recall of the product
Manufacturers can withdraw products from the market, about which they must upload a report to the system containing the series and the reason for the recall. Market participants who have the withdrawn series on their balance sheet will receive product withdrawal notifications and must confirm receipt of withdrowal information.
7
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