Overview of Indonesia’s Pharmaceutical Serialization Regulations

The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan) or Badan POM, also known as the Indonesian FDA, is a government agency in Indonesia tasked with safeguarding public health. It achieves this by regulating and overseeing prescription and over-the-counter medications, vaccines, biopharmaceuticals, dietary supplements, food safety, traditional medicines, and cosmetics.

Indonesia has made significant strides in pharmaceutical serialization regulations since 2017, aiming to enhance safety, traceability, and the competitiveness of its pharmaceutical and food industries. The implementation is being carried out in phases, with key milestones scheduled for 2023, 2025, and 2027.

Key Implementation Deadlines and Scope

* The serialization mandate may or may not apply to creams depending on whether they are classified as high-risk products, prescription-only medicines, or certain OTC products within Indonesia's regulatory framework. Non-medicinal creams or cosmetics are usually excluded.

Note: Under article 18 of the REGULATION OF THE INDONESIAN FOOD AND DRUG AUTHORITY NUMBER 33 OF 2018 ON THE APPLICATION OF 2D BARCODES FOR FOOD AND DRUG CONTROL.

(1) A Pharmaceutical Industry holding a Marketing Authorization is obligated to include 2D Barcodes on its primary Packaging.

(2) The obligation to include 2D Barcodes on primary packaging as referred to in section (1) is exempted for Drugs meeting the following conditions:

1. volumes under 10 (ten) millimeters;
2. primary blister packaging;
3. primary strip packaging;
4. ampule packaging;
5. prefilled syringe;
6. tube packaging with net weights under 10 (ten) grams;
7. single packaging;
8. stick pack;
9. suppositories; and
10. catch cover.

(3) 2D Barcodes as referred to in section (2) may be included on secondary packaging with a safety in place to ascertain the contents' originality.

In the event that the Health Supplements are packed in strips or blisters, Labelling must be printed on the packaging

Identification vs. Authentication Barcodes

1. Identification Barcode:

Products not requiring serialization—such as OTC drugs, traditional medicines, cosmetics, and processed foods—must include an identification barcode by 2023. This QR code contains essential details, including the Marketing Authorization Number and the NIE (Nomor Izin Edar) Number, which is a unique license number issued by BPOM. The NIE Number allows users to retrieve comprehensive product information from the Cek Produk BPOM database.

2. Authentication Barcode:

Serialized products, such as prescription drugs, narcotics, and other high-risk items, must incorporate an authentication barcode by 2025. This 2D Data Matrix code validates product authenticity and includes tracking details such as:

• Product Identification Number
• Batch Number
• Expiration Date
• Unique Serial Number

In compliance with GS1 standards, aggregation at the packaging level ensures efficient product tracking throughout the supply chain.

3. Aggregation and Reporting Requirements:

Aggregation, which involves linking individual product units to larger batches or shipments, has been a requirement since 2020. This process enhances transparency and security across the supply chain, enabling seamless tracking from production to end-users. BPOM mandates that aggregation data be reported to the agency and shared with trading partners when necessary.

Regarding company prefix:

• BPOM accepts GS1-compliant unique identifiers. If your company is already using a GS1 prefix to generate Global Trade Item Numbers (GTINs) and serial numbers, this prefix is generally accepted in Indonesia.
• Your current company prefix can be used as long as it complies with GS1 standards and is recognized as unique globally.
• No Mandatory Local Prefix: BPOM does not mandate the use of a local prefix if the product is serialized using a GS1-compliant system.
• However, if your current system does not follow GS1 standards, BPOM may require adjustments to ensure compatibility with their traceability framework.
• Ensure that the products associated with your international prefix are registered with BPOM using the same identifiers.

Regarding the importation and serialization of goods, the following points apply:

1. Importing Non-Serialized Goods

• Non-serialized pharmaceutical products can generally be imported only if they comply with all other importation and regulatory requirements set by BPOM.
• Upon arrival, these products must be serialized before they are distributed into the local supply chain.
• Serialization must adhere to the Indonesian traceability standards, which include generating and applying unique identifiers (such as barcodes or QR codes) compatible with BPOM's system.

2. Local Serialization After Importation

• Allowed: Serialization can typically be completed locally at a licensed facility.
• Process:
  • The local serialization process must align with BPOM’s technical guidelines for the traceability system.
  • Imported products are held in bonded warehouses or at authorized facilities until serialization is complete.
  • The serialized data must be uploaded to BPOM’s traceability system to finalize compliance.

3. Timing and Penalties

• Importers are usually required to serialize and register products before they are made available for distribution or sale in the local market.
• Failing to serialize imported goods before distribution could result in penalties, including fines, product recalls, or restrictions on future imports.

4. Steps for Compliance

• Verify that the non-serialized goods meet all other regulatory requirements (e.g., registration, permits).
• Work with a licensed local facility capable of performing serialization.
• Ensure serialized data is uploaded to BPOM’s system within the mandated timeline

Preparing for Compliance

With the 2023, 2025, and 2027 deadlines approaching, pharmaceutical manufacturers, contract manufacturers, importers, and other supply chain participants must take proactive steps to comply with BPOM’s regulations. Given the broad scope and complexity of these requirements, early preparation and meticulous implementation are essential to achieving compliance and maintaining product standards.

Conclusion

Indonesia's step-by-step approach to pharmaceutical serialization, guided by BPOM's regulatory framework, marks a significant advancement in ensuring product safety and supply chain transparency. By meeting these requirements, Indonesia not only adheres to global best practices but also strengthens its competitive position in the international pharmaceutical market. As the deadlines near, it is crucial for industry stakeholders to fully prepare for compliance, safeguarding both their products and the consumers who depend on them.

Disclaimer:

The views and opinions expressed in this blog are those of CosmoTrace and are based on our observations and insights gained from industry interactions. This content is provided for informational purposes only and should not be construed as legal or regulatory advice. CosmoTrace makes no representations as to the accuracy, completeness, or reliability of any information presented, and any reliance you place on such information is strictly at your own risk.

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