Overview

The Indonesian National Agency of Drug and Food Control (BPOM) has taken proactive steps to enhance a secure and sustainable pharmaceutical supply chain. In 2022, BPOM replaced the 2018 law on serialization and traceability with an updated regulation. In 2023, BPOM launched the e-Labeling Pilot Project, reinforcing its commitment to future-ready pharmaceutical oversight.

This document outlines the labeling process, including traceability, serialization, aggregation requirements, and noted exceptions.

Table of Contents

1. Labeling
2. Traceability Requirements
3. Serialization Requirements
4. Aggregation Requirements
5. Exceptions 

1. Labeling

All pharmaceutical manufacturers in Indonesia must use a 2D Data Matrix barcode to enable product tracking and tracing. The barcodes must comply with GS1 standards, as mandated by Regulation No. 22/2022, effective from October 5, 2022.

Manufacturers can either:

• Generate barcodes independently, or
• Obtain them from BPOM.

There are two types of barcodes:

• Identification Barcode
• Authentication Barcode

Implementation Deadlines

• By December 7, 2023: All eligible pharma products must have an Identification Barcode.
• By December 7, 2025:
  • All eligible pharma products must include an Authentication Barcode.
  • All prescription drugs, including biological products, must adopt 2D barcoding.
• By December 7, 2027: All narcotic and psychotropic drugs must comply with 2D barcode requirements.

2. Traceability Requirements

The Identification Barcode is a QR code used to:

• Identify a product in the market.
• Verify product legality.

Applicability

Products not requiring serialization should only include an Identification Barcode. These include:

• Traditional medicines
• Over-the-counter drugs
• Cosmetics
• Supplements
• Processed foods

Note: Barcodes must be obtained through electronic Marketing Authorization (MA) approval and include:

• MA Number
• NIE* Number

The NIE (Nomor Izin Edar) is a product license number issued by BPOM. It indicates the product’s origin (domestic or imported) and provides access to product data in the BPOM’s “Cek Produk” database.

3. Serialization Requirements

Serialization uses the Authentication Barcode, which is a 2D Data Matrix containing a unique identifier.

Applicability

Serialization is required for:

• Narcotics
• Ethical drugs
• Psychotropic substances
• Other high-risk products

Barcode Data Requirements

• Marketing Authorization Number and/or GS1 GTIN
• Production or Batch Number
• Expiration Date
• Serial Number

Note: To request barcodes via the Track and Trace app, businesses must submit:

• MA Number
• Expiry Date
• International Product ID (if applicable)
• Number of primary, secondary, and tertiary codes required

4. Aggregation Requirements

Aggregation is mandatory and must follow GS1 standards using the SSCC (Serial Shipping Container Code).

5. Exceptions

The following products are exempt from barcode requirements:

• Blister packs, strip packs, pre-filled syringes, ampoules, and tubes under 5 mg
• Drugs in volumes less than 5 ml
• Stick packs, single packaging, suppositories, and catch covers