高风险 (完整商业许可证，需跨部门技术现场审查)
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Processing: 1 - 14个工作日
Food and Drug Distribution / Marketing Authorization (BPOM NIE)
Statutory Basis: 关于基于风险的商业许可实施的2021年第5号政府条例 (PP No. 5/2021)
Detailed Application Procedure
1. Register enterprise account on e-reg.pom.go.id.
2. Submit facility audit report and quality manager credentials (Apoteker/Food technologist).
3. Upload product dossier: ingredients, Certificate of Analysis (CoA), manufacturer specs.
4. Pay official state testing and registration fee.
5. Undergo evaluation and laboratory verification tests by BPOM evaluators.
6. Receipt of official 15-digit Distribution Authorization Number (Nomor Izin Edar - NIE).
Mandatory Prerequisites & Commitments
Facility Good Manufacturing Practice (CPPOB/CPKB) audit, complete laboratory assay certificates, formula composition, packaging artwork.
Ongoing Compliance & LKPM Obligations
Valid for 5 years, renewable upon re-application before expiration.
Procedure Details
- Issuing Authority:
- Indonesian National Agency of Food and Drug Control (BPOM RI)
- KBLI Codes:
- Pharmaceuticals, Cosmetics, Processed Foods, Dietary Supplements
- Risk Classification:
- 高风险 (完整商业许可证，需跨部门技术现场审查)
Need an Official Permit Petition?
Draft a formal letter of application addressed directly to the licensing authority (DPMPTSP or Sectoral Ministry).
Draft Application Letter