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Indonesia track and trace evolves dynamically, starting from traceability project in 2018 to bold goals for 2025-2027.

 

 

 

 

 

Looking back, the Indonesian National Agency of Drug and Food Control (BPOM) is working quite proactively on enhancing a secure and sustainable pharma supply chain. In 2022, the organization replaced a previous law conceived in 2018 that mandated serialization and traceability. Moreover, going straightforward and implementing future-ready approaches, in 2023 BPOM launched an initiative called the e-Labeling Pilot Project. Below we will discover the specifics of labeling process, including traceability, serialization and aggregation requirements.

 

Labeling

 

All pharmaceutical manufacturers must pack their products with a 2D Data Matrix barcode to facilitate tracking and tracing. BPOM published the Revised Regulation on the Implementation of 2D Data Matrix barcode in Pharmaceutical and Food Traceability No. 22/2022, which entered into force on October 5, 2022. The barcodes used must be in line with GS1 standards.

 

Pharmaceutical companies can generate the barcodes on their own or obtain them from the BPOM. There are two types of barcodes for marking – Identification Barcode and Authentication Barcode. Regarding their placing in service:

 

• By 7 December 2023, all eligible pharma products must be marked with an Identification Barcode
• By 7 December 2025, all eligible pharma products must be marked with an Authentication Barcode
• By 7 December 2025, all prescription drugs, including biological products, must transition to the 2D barcode application.

 

7 December 2027 is the latest transition date for the implementation of the 2D barcode application for all drugs in the Narcotic and Psychotropic category.

 

 

 

Traceability Requirements

 

The Identification Barcode (a QR barcode that identifies a product in the market and verifies the legality of a product) is used for the purpose of establishing traceability.

 

The applicability of Identification Barcode covers the following scope:

 

• Products that do not need to be serialized must only have an identification barcode;
• Traditional medicines, over-the-counter drugs, cosmetics, supplements, and processed foods.

 

Note: Manufacturers are required to acquire the barcode issued through electronic Marketing Authorisation (MA) approval.

 

The code must contain the Marketing Authorization Number and NIE* Number.

 

Notes: NIE is a license number issued by the BPOM. It consists of a combination of letters and numbers. The number of characters and length depends on the type of product. The number can be used to read whether the product was manufactured domestically or abroad, and it gives access to further product data in the Indonesian database Cek Produk BPOM.

 

 

 

Serialization Requirements 

 

Regarding Indonesian legislation, for serialization will be used Authentication Barcode – a serialized product identifier and 2D Data Matrix barcode used in reporting and verifying a product’s authenticity by GTIN, batch (lot) number, expiry date, and serial number.

 

The applicability of Authentication Barcode covers the following scope:

 

• Products that need to be serialized will need an authentication barcode
• All narcotics, ethical drugs, psychotropic drugs, and other high-risk products.

 

Note: A business can either get it issued from the BPOM, or from an independent source.

 

The code must contain the following information:

 

• Marketing Authorization Number and/or Product identification number i.e. GS1 GTIN
• Production code or batch number
• Expiration date
• Serial number

 

Note: To get the barcode issued, you must file an application on the track and trace app. The application requires details such as the MA number, expiry date, international product identity (if any), number of primary codes required, number of primary codes required on secondary packaging, and number of secondary codes required on tertiary packaging.

 

 

 

Aggregation Requirements 

 

Aggregation is mandatory and should follow GS1 standards – SSCC code.

 

 

 

Exceptions

 

Not all pharmaceutical products require barcodes. Products/packs that are exempted from the requirement:

 

• Blister packs, strip packs, pre-filled syringes, ampoules, and tubes less than 5 mg in weight;
• Drugs having a volume of less than 5ml;
• Stick packs, single packaging, suppositories, and catch covers.

 

In the next article, we will provide you with an overview of the Indonesian Electronic Leaflet Pilot (2023-2025) – its current status, future phases, and process workflow.

 

 

 

Meanwhile, if you need more information regarding track and trace regulatory compliance in Indonesia, schedule a free consultation with our expert >> communication@softgroup.eu