Learn About Indonesia’s Pharma Serialisation and Traceability Regulation

From the colour, shape, and size of the products, to the packaging – which looks like the real thing – these bogus pharmaceuticals either contain small amounts of active ingredients, or none at all. Not only does this reduce trust in the healthcare system, but it puts patient safety in danger as well.

To counter this worldwide problem, many countries have started developing an end-to-end track and trace system to facilitate chain-wide drug visibility, thereby preventing the distribution of fake products. Indonesia, the South-Asian island nation, has been one of the latest additions to this list of countries, featuring a quite unique set of serialisation requirements.

Non-compliance with serialisation requirements can lead to heavy fines, and, in the most serious cases, legal consequences. Therefore, it’s essential that everyone working in the pharmaceutical chain – distributors, manufacturers, packagers, etc. – be aware of the guidelines.

To help you out, here are all the key points regarding Indonesia’s serialisation and traceability regulation:

• All pharmaceutical manufacturers must pack their products with a 2D barcode to facilitate tracking and tracing
• The barcodes used must be in line with GS1 standards
• Pharmaceutical companies can generate the barcodes on their own, or obtain them from the Indonesian Food and Drug Authority, aka BPOM-Bedan Pengawas obat dan Makanan
• Two barcodes will be used for serialisation – Identification Barcode and Authentication Barcode
• By 2023, all eligible pharma products must be marked with an Identification Barcode
• By 2025, all eligible pharma products must be marked with an Authentication Barcode

Indonesia’s traceability requirements stipulate the use of two barcodes: one for identification, and one for authentication. Identification barcodes are to be stuck on products that don’t require serialisation, whereas the authentication barcode needs to be stuck on the products that do.

The Identification Barcode is a QR code that applies to traditional medicines, over-the-counter drugs, cosmetics, supplements, and processed foods. Manufacturers are required to acquire the barcode issued through electronic Marketing Authorisation (MA) approval.

THE IDENTIFICATION BARCODE CONTAINS THE FOLLOWING INFORMATION:

• MA Number (NIE)/Registration number
• Validity of the MA Number (NIE)

As for the Authentication Barcode, all narcotics, ethical drugs, psychotropic drugs, and other high-risk products are required to have it on their packaging. A business can either get it issued from the BPOM, or from an independent source.

THE AUTHENTICATION BARCODE CONTAINS THE FOLLOWING DATA:

• MA Number or an internationally valid identity product number
• Batch No/Production code
• Serial Number
• Expiry date

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.

NOT ALL PHARMACEUTICAL PRODUCTS REQUIRE BARCODES. HERE ARE THE PRODUCTS THAT ARE EXEMPT FROM THE REQUIREMENT:

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

WRAPPING UP

Along with serialisation requirements, the Indonesian Government also had aggregation in mind. With end-to-end track & trace and aggregation implementation, Indonesian pharmaceutical companies will be able to ensure no counterfeit drugs enter the supply chain, ensuring complete public health safety.