Understanding BPOM's Role in Business Licensing: When Is BPOM Approval Required?

In Indonesia, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – BPOM) plays a critical role in regulating the safety and quality of consumer goods, particularly food, beverages, drugs, traditional medicines, and cosmetics. For businesses operating in these sectors, understanding when and why BPOM approval is required is crucial to ensure compliance and avoid legal or operational disruptions. This guide outlines BPOM's role in business licensing, clarifies the types of products that require BPOM approval, and explains how businesses can navigate the approval process efficiently.

The Importance of BPOM in Indonesia’s Regulatory Ecosystem

BPOM is the Indonesian government agency responsible for overseeing the control of drugs and food safety. Its mission is to protect public health by ensuring that all food and drug products circulating in the market are safe, effective, and of high quality.

Why BPOM Exists

BPOM’s presence ensures that consumers are protected from harmful substances or mislabeled products. It enforces safety through evaluations, laboratory testing, market surveillance, and law enforcement, ensuring businesses comply with stringent quality standards.

Legal Framework

BPOM operates under various legal frameworks, including:

• Law No. 36/2009 on Health
• Government Regulation No. 72/1998 on the Safety of Pharmaceutical Products
• BPOM Regulation No. 27/2017 on the Supervision of Imported and Exported Food Products

These frameworks ensure that BPOM can take regulatory actions against non-compliant businesses.

When Is BPOM Approval Required?

Not all businesses in Indonesia are required to obtain BPOM approval, but those producing or distributing regulated products must comply.

1. Food and Beverages

Mandatory for:

• Processed food products (both local and imported)
• Bottled drinks, dairy products, infant food, supplements, and snacks

Not required for:

• Fresh foods or unprocessed agricultural products (e.g., fruits, vegetables, meat sold directly)

All processed food products sold in packaging must be registered and labeled with a BPOM registration number (MD for domestic, ML for imported products).

2. Cosmetics

Required for:

• Makeup products
• Skincare items
• Hair care products
• Fragrances

Cosmetic companies must ensure their ingredients comply with BPOM’s “positive list” and register each product to obtain a Notification Number, which must appear on the product label.

3. Drugs and Traditional Medicines

Compulsory for:

• Prescription medications
• Over-the-counter drugs
• Herbal medicine (jamu)
• Vitamins and supplements

BPOM approval ensures these products are not only safe but also efficacious. Companies must undergo strict clinical testing, GMP certification, and detailed evaluation procedures.

4. Health Supplements and Functional Foods

Products like energy drinks, meal replacement powders, and probiotics must be registered with BPOM. They fall under a gray area between food and medicine, but still require compliance with food safety and efficacy standards.

Exemptions and Special Cases

Products Sold in Limited Scale

Micro and small enterprises (UMKM) may benefit from simplified BPOM registration under programs like the “Pangan Olahan Industri Rumah Tangga” (PIRT). While PIRT is regulated by local health departments, certain categories still fall under BPOM’s oversight.

E-commerce and Resellers

If you’re an online seller distributing imported goods without BPOM registration, your business could face seizure of goods or fines. Resellers must ensure that the products they sell are BPOM-approved and legally imported.

Consequences of Skipping BPOM Registration

Failing to register your products with BPOM can have serious implications, including:

• Product seizures
• Fines or administrative sanctions
• Business license revocation
• Criminal prosecution for repeated violations

BPOM actively monitors traditional markets, supermarkets, and online platforms to catch violations. It’s crucial to ensure compliance from the start to avoid disruption.

BPOM Registration Process Overview

The process of obtaining BPOM approval depends on the product category but generally involves:

Step 1: Business Licensing

Businesses must first hold a valid NIB (Nomor Induk Berusaha) and, if required, an operational license (Izin Operasional). These can be obtained via the Online Single Submission (OSS) system.

Step 2: Product Evaluation and Document Submission

Submit a comprehensive dossier including:

• Product formula and composition
• Manufacturing process
• Lab results
• Packaging and labeling details

This documentation must be submitted via BPOM’s online portal.

Step 3: Laboratory Testing and Verification

BPOM may require physical product samples for laboratory testing to ensure safety and efficacy. This step is mandatory for certain product categories like drugs, supplements, and imported food.

Step 4: Issuance of Approval Number

Once the evaluation is complete, BPOM will issue an approval number:

• MD or ML code for food
• NA code for cosmetics
• TI or TR code for traditional/herbal medicine

This number must be printed on the product packaging as proof of registration.

Timeline and Costs

• Processing time: Varies from 14 days to several months depending on the product complexity and completeness of documentation.
• Fees: Start from IDR 500,000 for local food products and can go up to several million rupiah for pharmaceutical evaluations.

BPOM Approval vs. Halal Certification

Some business owners confuse BPOM registration with Halal certification, which is issued by the Halal Product Assurance Agency (BPJPH). Both may be required for food and cosmetic products, but they serve different purposes:

• BPOM ensures safety and compliance.
• Halal ensures compliance with Islamic law.

For Muslim-majority markets in Indonesia, holding both BPOM and Halal certification is a strong market advantage.

Tips to Ensure Smooth BPOM Approval

1. Consult a professional to guide you through document preparation.
2. Ensure accurate labeling, including mandatory information such as expiry date, net weight, and storage instructions.
3. Keep your business licenses updated, as expired NIB or operational licenses can halt the process.
4. Monitor changes in BPOM regulations, which are regularly updated.

Conclusion

Securing BPOM approval is more than a legal obligation—it’s a strategic business move that builds consumer trust and market credibility. Whether you are an international brand entering Indonesia or a local entrepreneur launching new products, aligning with BPOM regulations ensures your business can operate without legal friction and meet the growing consumer demand for quality and safety. Understanding when BPOM approval is required—and how to obtain it—saves time, avoids penalties, and enables long-term growth in one of Southeast Asia’s largest consumer markets. Navigating the BPOM approval process can be complex, especially for foreign brands unfamiliar with Indonesia’s regulatory landscape. CPT Corporate provides expert support in securing product registration, legal compliance, and business licensing in Indonesia. Whether you need help with documentation, submission, or liaising with BPOM, our team is ready to assist.