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Indonesia’s Pharmaceutical Track and Trace Regulation: An Overview
Indonesia is introducing new track and trace regulations for pharmaceuticals to ensure product safety and combat counterfeit drugs. This move involves the implementation of serialization and the use of 2D barcodes, aligning with international standards to increase transparency in the pharmaceutical supply chain.
Key Requirements and Deadlines
By 2023, all pharmaceutical products in Indonesia must be equipped with an Identification Barcode, and by 2025, an Authentication Barcode is required. These barcodes, which include GS1 2D Data Matrix codes for authentication and QR codes for identification, will be used for tracking pharmaceuticals from production to consumer.
What the Regulations Entail
The Identification Barcode is used for products that do not need serialization, such as over-the-counter medications and some processed foods, while the Authentication Barcode is necessary for prescription drugs and other regulated items. This system ensures that all products can be traced back to their origin, enhancing the safety and integrity of medicinal products.
Manufacturers must adapt to these regulations by the specified deadlines to avoid penalties. The implementation of these barcodes will allow for better management of product recalls, improved inventory tracking, and prevention of counterfeit products entering the market.
The Indonesian Food and Drug Authority (BPOM) is responsible for overseeing the compliance of these regulations. Pharmaceutical companies are encouraged to prepare in advance to meet these regulatory requirements, ensuring that their products are properly serialized and traceable.
Looking Ahead: Ensuring Compliance and Safety
As the 2023 and 2025 deadlines approach, manufacturers must ensure they are fully compliant with the new regulations. This initiative not only aims to protect consumers but also to enhance Indonesia’s competitiveness in the global pharmaceutical market.
VISIOTT TPS: Your Partner in Complying with Indonesia’s Pharmaceutical Regulations
VISIOTT TPS offers systems that help pharmaceutical manufacturers in Indonesia meet the new track and trace regulations. Our products are designed to handle both Identification and Authentication Barcodes required by the regulations. We provide tools for easy integration into your current processes to ensure compliance with the latest requirements.
With VISIOTT TPS, manufacturers receive support to adapt to these new regulations. We offer guidance on how to implement these changes smoothly and maintain compliance with Indonesian regulations as they evolve.
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