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Product overview
Comply with Indonesia’s serialization and reporting requirements
TraceLink Indonesia Pharmaceuticals leverages our global compliance platform to help pharmaceutical manufacturers meet the evolving data management and compliance reporting requirements documented by BADAN POM (BPOM) for submission of product and operational data to the BPOM system.
With Indonesia Pharmaceuticals, you can:
Industry challenges
New compliance requirements demand new compliance solutions
Today’s marketing authorization holders and pharmaceutical manufacturers face immense challenges managing regulatory compliance and navigating evolving requirements in Indonesia. These challenges include:
Complex national labeling and reporting requirements
Pharmaceutical companies 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.
Complex national labeling and reporting requirements
Product marking and reporting based on classification
There are two aspects of product marking, data management, and reporting: identification to verify the legality of a product, and authentication to verify a product’s authenticity by GTIN, batch (lot) number, expiry date, and serial number.
Product marking and reporting based on classification
Ambiguous compliance requirements and processes
The specific compliance requirements, data management processes, and reporting needs for companies with products in the authentication category are still evolving, requiring frequent updates from manufacturers.
Ambiguous compliance requirements and processes
Capabilities
TraceLink Indonesia Pharmaceuticals
Since 2009, TraceLink has been the industry leader in delivering regulatory compliance and serialization solutions for the global pharmaceutical industry in more than 30 countries.