Pharmaceutical companies that distribute products within Indonesia must comply with labeling requirements for serialization and reporting certain events to the National Agency of Drug and Food Control (BPOM) Track and Trace Anti-Counterfeit (TTAC) website.
The law covers two aspects of product marking, data management, and compliance reporting, depending on product classification:
- Identification (a barcode that identifies a product in the market and verifies the legality of a product)
- Authentication (a serialized product identifier and 2D barcode used in reporting and to verify a product’s authenticity by GTIN, batch (lot) number, expiry date, and serial number).
Although the initial central system is live, the specific compliance requirements, data management processes, and reporting needs for companies with products in the Authentication category are still evolving.
Government Reporting, Serialization