Learning Indonesian Pharmaceutical Serialization & Traceability Requirements
Many countries have come to the conclusion that the only thing that can prevent the harm caused by counterfeiting pharmaceuticals to human health, pharmaceutical manufacturers and governments is traceability. Traceability systems where manufacturers and controllers work as a team, carried out under the control of the National Medicines and Food Control Agency (BPOM) for the Indonesian pharmaceutical serialization and traceability.
Since 2017, the government has been working on Indonesian pharmaceutical serialization regulations. There has been established a single regulation that will require the use of 2D barcodes on all pharmaceuticals, cosmetics, and processed foods. The first application of pharmaceutical traceability in Indonesia started with QR code. In 2018, BPOM announced to the Indonesian people that serialization should be done by applying the GS1 2D code as of 2019. Afterwards, it was decided that QR code and GS1 datamatrix could be applied.
Deadlines for Compliance: Critical Dates of Indonesian Pharmaceutical Serialization
All pharmaceuticals must be serialized and have a 2D data matrix code by 2025. QR codes will be required for over-the-counter and processed foods as early as 2023.
Indonesian Pharmaceutical Serialization Implementation System
The Indonesian Identification Barcode and the Authentication Barcode are two different types of barcodes in terms of purposes as simple product identification and more complicated product authentication. There is no need for serialization if a product category is designated for basic “identifying.” A serial number will be required for those specified in the “authentication” categories. All pharmaceuticals must have “authentication barcodes.”
By 2023, all pharmaceutical items (over-the-counter and prescription) need to have an identification barcode which includes MA Number (NIE)/Registration number, Validity of the MA Number (NIE).
PS: The NIE Number (Nomor Izin Edar) is a license number issued by the BPOM.
Pharmaceuticals must be serialized and have an authentication barcode which includes MA Number or an internationally valid identity product number, batch No/production code, serial number, expiry date by 2025. The BPOM also maintains the authority to add other product types to the list of serialized products.
The following information must be included in the authentication code:
- A number that identifies a product, such as the GS1 GTIN.
- Marketing Authorization Number (BPOM)
- Batch number or production code
- Date of expiration
- Unique identifier
With an expansion of the regulation in 2020, the government has rmandated aggregation from the packaging level. The exact standards for serial number generation or the format of the human-readable expiration date.
Because a package can have many barcodes, the BPOM requires that the authentication code include the suffix “BPOM RI” when there are multiple barcodes on the package. The BPOM must get all product data, including aggregation data. In addition, the information may need to be shared with other trading partners. Within the scope of this published requirement, no details were given about the SSCC label.
All-In-One Solutions for Indonesian Pharmaceutical Serialization
Proving itself with the experience in traceability solutions and the benefits of this experience worldwide, VISIOTT also produces effective and efficient systems that comply with pharmaceutical labeling applications in Indonesia. VISIOTT, which has innovative solutions for cartons, unfolded cartons, vials, and bottles used in pharmaceutical packaging, also offers software solutions for line management and notifications. While managing your hardware with VISIOTT Line Manager (Level 2), you can store your data by assigning work orders to lines with VISIOTT Plant Manager (Level 3). In addition, VISIOTT Plant Manager software is capable of creating serial numbers, master data, and product recipe management. With VISIOTT Enterprise Manager (Level 4), it becomes easier for companies with more than one production, shipping, and storage facility to manage their traceability processes. This software can also generate and manage serial numbers easily.
VISIOTT solutions comply with Indonesian pharmaceutical serialization regulations. The solutions offered are in a structure that can be easily integrated. All systems are GAMP 5 certified and 21 CFR Part 11 compliant. Since VISIOTT believes in the success of sustainable friendship, the spare parts service it provides is long-term and 24/7 after-sales support is ready to serve. Do not hesitate to contact our experts who wait for you with your questions to learn more about pharmaceutical labeling, serialization, aggregation processes and Indonesian pharmaceutical serialization!