BPOM License for Distribution
Products that are regulated by the BPOM must be licensed by the administration before they can legally enter into circulation
Overview of the BPOM license for product circulation
The BPOM license for product circulation and distribution, also known locally as the Izin Edar, is required for any food and drug products that are entering the Indonesian market, whether through importing or manufacturing. The permit is only necessary once the product is ready for circulation. The Distribution license is valid for 5 years and can be extended.
Requirements for securing a BPOM license for circulation
Emerhub can assist you in securing the necessary documents and applying for a BPOM distribution license. Depending on the type of item, it is required that you demonstrate the following criteria to receive distribution approval:
Food:
- Product evaluation and testing based on risk level
- Successful audit of distribution facilities demonstrating compliance with safety standards
- Labels and product ingredients that show compliance with quality and safety standards
Drugs:
- Results of clinical and non-clinical trials showing efficacy and safety of the product.
- Production process that is properly licensed and meets quality standards and Good Manufacturing Practices (GMP) standards
- Labels and product information that are objective, non-misleading, and allow for drugs to be used properly and safely.
Processed foods that are exempt from distribution licensing
- Processed foods with a shelf life of less than 7 days
- Home industry processed foods
- Small quantity imports for purposes other than consumption (e.g. research)
- Bulk imports not intended for direct sale to end consumer
- Raw materials not being sold to end consumer
- Products that are sold in small quantities and packaged only upon sale and in front of the buyer
- Food that is directly ready-to-eat for the end consumer
- Minimally-processed harvested food (e.g. only drying, peeling, washing, cutting, blanching, freezing, or similar)
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