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Food Supplement Registration in Indonesia

Overview

A distribution permit is given by Indonesian government agencies like BPOM or the Ministry of Health, confirming a product meets safety, quality, and benefit standards for legal sale in Indonesia.

Business Hub Asia offers comprehensive support for food supplement registration, guiding clients from the initial stages through license acquisition using a legal and strategic approach. Through understanding the latest BPOM regulations and technical support, we minimize the risk of rejection and accelerate your product’s access to the market. Our solutions help brands assert safety, quality and trustworthiness in the eyes of consumers and regulators.

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Key Features

Product Category & Registration Pathway Consultation

Classify product (OTC, supplements, hard drugs, vaccines) and identify registration pathway (NAS, Rapid Evaluation, Emergencies).

Technical Document Preparation & Validation

Assistance in preparing documents such as formula, COA, stability data, pharmacology, clinical trial results, and active ingredient specifications.

Product Registration through BPOM e-Registration

Submit electronic health supplement data to BPOM's official system for administrative verification and technical evaluation.

Evaluation, Clarification & Laboratory Test Assistance

Monitoring of the evaluation process, active communication with BPOM evaluators, and assistance in revising technical documents if needed.

Issuance of Distribution Permit (CD, TR, SD, or other registration number)

After passing all stages, the product will obtain an official registration number from BPOM and is ready to be marketed legally.

Minimum Requirements

Company legality

NIB, NPWP, Deed, SIUP, and production license/PIB

Manufacturing Certificate

CPOB, CPOTB, or CPPOB certificate (according to product type)

Raw Material & Formula Data

Complete raw material & formula specification data

Lab & Clinical Results

Laboratory test reports and/or clinical trials

Principal Appointment

Letter of appointment from the principal (for imported products)

Labeling

Indonesian language product labels and information

Business Entity Requiring Food Supplement Registration

Local Supplement Manufacturer

Supplement Importers & Distributors

Local and international supplement brands

Process and Timeline

1

Initial Consultation & Product Classification

Our team identifies the category of dietary supplements according to BPOM regulations (Reg. No. 32/2022 & changes to Reg. 15/2024). Estimated time: 1-2 working days.

2

Technical & Legal Documents Collection

Prepare technical files (composition, Bahasa Indonesia labeling), CoA, GMP, stability, and proof of registration in the country of origin. Estimated time: 10-20 working days.

3

Submission to BPOM e-Registration System

Initial document submission to BPOM for completeness verification and pre-legal classification (category 1-4). Estimated time: 20 working days.

4

Technical Assessment & Evaluation

Thorough examination by BPOM on safety, quality, and efficacy based on formulation and clinical data if required. Estimated time: 30-180 working days, depending on product type.

5

Issuance of Distribution License (NIE)

After passing verification, BPOM issues an NIE, which is valid for 5 years. Estimated Time: 1-3 working days after approval.

*Total estimated process: 3-11 months, depending on formulation complexity & document completeness.

Important Consideration

  • Supplement and traditional medicine products must meet safety, efficacy, and quality standards under BPOM regulations.
  • Drugs and vaccines require more complex documentation, including pharmacology and clinical trial data.
  • Drug raw materials (API) must also be registered to be legally used and traded in Indonesia.
  • Special registration pathways such as Fast Track, Emergence, or Acceleration are available for national strategic or pandemic products.

Frequently Asked Questions

What products must be registered with BPOM?

All health supplement products, traditional medicine (jamu), pharmaceutical drugs, vaccines, biopharmaceuticals, and medicinal raw materials must be registered before distribution.

What is the difference between TR, CD, and SD registration numbers?

TR: Traditional medicine
CD: Hard drugs and limited over-the-counter drugs
SD: Health supplements
TI/CD/BIO: For vaccines and other biotechnology products

Do imported food supplements also have to have a BPOM distribution license?

Of course, imported products must be registered by an authorized distribution license holder in Indonesia and go through the same evaluation procedures.

Are laboratory tests and clinical trials mandatory?

For drug and vaccine products, laboratory tests and clinical trials are the main requirements. For supplements and traditional medicine products, COA and ingredient safety data are required.

Who can be a distribution license holder?

Only companies incorporated in Indonesia that have production licenses and certifications (CPOTB, CPOB, etc.) can become authorized distribution permit holders.

How long is the distribution permit valid for?

The validity period of BPOM registration is usually 5 years and can be extended before expiration.

Register Your Products with Confidence

Navigate the complex product registration process for food, cosmetics, health, and other regulated products efficiently and compliantly.

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