The National Agency of Food and Drug Control (BPOM) oversees health supplements. Under the Indonesia health supplement regulations, only registered Indonesian entities can import and distribute supplements. Products undergo BPOM’s certification process before entering the Indonesian market.
Food supplement registration in Indonesia can be conducted online or offline. This process includes inspections to ensure your products comply with all safety and standard distribution requirements.
Indonesia’s Regulation on Health & Food Supplements Registration
Health and food supplements regulations in Indonesia are made by the National Agency of Drug and Food Control Regulations No. 17/2019 and No. HK.00.05.41.1381. These regulations govern the quality requirements and procedures for manufacturing health supplements.
Hiring a professional to handle your food supplement registration services in Indonesia is crucial for successful product registration. Navigating the complex regulatory requirements and documentation processes in Indonesia can be challenging, and a knowledgeable expert can help streamline the process and ensure compliance with all necessary regulations.
Registration for Imported Food Supplements
Companies seeking to register imported food supplements must actively operate in industries related to health and wellness, pharmaceuticals, or food and beverage. Food supplement registration often involves heavy oversight for risk mitigation concerning public health safety.
- Pharmaceutical industry
- Traditional medicine industry
- Food industry
- A business entity in the field of marketing dietary supplements that has received a direct appointment letter from the industry of the originating country
It’s important to note that these companies must also have importer licenses in pharmaceutical supplies and Good Manufacturing Practices Certification. These regulations could be complicated to fulfill. Hence using food supplement registration services in Indonesia, like Incorp Indonesia, could be very helpful.
Health Supplement Registration Indonesia: The Requirements
Fulfilling specific requirements to register your product in Indonesia is essential. Please comply with these requirements to ensure you complete the necessary distribution processes. It is crucial to ensure that all requirements are met to avoid delays or obstacles in the registration process.
- Import license
- Authorization letter from the manufacturer
- Legalized Certificate of Free Sale issued by the origin country’s government
- Trade business license
Health Supplement Registration: Halal Certification
Halal certification in Indonesia has existed for some time, but until 2019, it was completely voluntary. According to Law No. 33/2014 on Halal Products Assurance, many consumer products and related services entering and trading in Indonesia must now obtain the Halal certification.
Food Supplement Registration Category
Food supplements are categorized based on their ingredients, intended use, and risk level, divided into new and variation registration. This categorization is intended to ensure the safety of public consumption. Here’s a breakdown of the typical categories for food supplement registration in Indonesia:
License services for each sector
| Registration Type | Category | Description |
|---|---|---|
| New Registration | Category 1 | Basic supplements contain vitamins, minerals, amino acids, carbohydrates, proteins, and fats. |
| New Registration | Category 2 | Supplements containing ingredients in Category 1, plus additional isolates and natural materials. |
| New Registration | Category 3 | Supplements in Categories 1 or 2 with claims of new uses, forms, dosages, or regimens. |
| New Registration | Category 4 | Minor changes: product name, package size, labeling claims (without affecting benefits), design, factory/licenser name (ownership unchanged), or importer name (ownership unchanged). |
| New Registration | Category 5 | SMore significant modifications include raw material or finished product specifications, stability testing, changes to production technology or site, or adjustments to package types. |
| New Registration | Category 6 | Formula changes where the main ingredients remain within the same category or alterations to additives without impacting benefits. |
Top Sectors for Health and Food Supplement Products in Indonesia 2024
As of 2024, several sectors for health and food supplements are prominent in Indonesia due to various factors such as consumer needs and preferences, market demand, and regulatory environment. Here is the list of top sectors for health and food supplement products in Indonesia in 2024:
1. Vitamin and minerals
Vitamin and mineral products are the largest sector in health and food supplements and are estimated to reach a market volume of USD 739,7 million in 2024.
2. Cough and cold remedies
Following the vitamins and minerals, this sector of health and food supplements is predicted to be the second largest sector in Indonesia. It’s predicted to reach a revenue of USD 608,40 million in 2024.
3. Analgesics
The Analgesics sector is projected to experience an annual growth rate of 9,52% from 2024 to 2028. It’s expected to reach a revenue of USD 571,90 million by 2024.
4. Digestives
Probiotics, prebiotics, and fiber supplements are projected to see continued growth as consumers focus on overall well-being. The market of the digestive sector is predicted to reach USD 339,50 million by 2024.
5. Skin Treatment
Competing closely with the digestive sector, skin treatment is also one of the sectors that are expected to experience huge growth in the health and food supplement industry. It’s expected to reach a revenue of USD 323,10 by 2024.
Health and food supplement registration by InCorp Indonesia
Starting a company
Only registered legal entities can register products in the country, so foreign investors must set up a health supplement company in Indonesia. With InCorp Indonesia, investors can establish a foreign-owned company from scratch most seamlessly and securely.
Product license holder
If you prefer not to establish a company, InCorp Indonesia can still register your health supplement using our product license holder service. This enables you to collaborate with various distributors and end partnerships without worrying about regulatory issues.
Extension of food supplement registration
Every health supplement in Indonesia gets a unique registration number valid for five years. For renewal, start six months before expiry. Renew at least a month before to avoid restarting. Contact InCorp Indonesia early to prevent delays.
Health Supplement Registration Workflow
| Information | Unit | Carton | Labels | Blisters/Strips | Catch Covers/Envelopes | Ampoules/Vials | Notes |
|---|---|---|---|---|---|---|---|
| Product Name | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Dosage Form | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Package Size | ✓ | ✓ | ✓ | ||||
| a. Name and strength of active ingredient(s) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| b. Generic name should appear under the brand name. The minimum size is 80% of the brand name | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Local Production | ✓** | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Name of Applicant | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Address of Applicant | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Imported Drugs | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Name of Applicant and Manufacturer of imported drug | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Address of Applicant and Manufacturer of imported drug | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Toll Manufacturing | ✓** | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Name of Applicant and Manufacturer | ✓** | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Address of Applicant and Manufacturer | ✓** | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Local Production under License | ✓** | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Name of Applicant and License | ✓** | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Address of Applicant | ✓** | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Registration Number | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Batch Number | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Date of Production | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Expiration Date | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Indications | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Posology | ✓ | ✓ | ✓ | ✓ | ✓ | ✓** | |
| Contraindications (if any) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Adverse Reactions (if any) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Drug Interactions | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Warnings – Precaution | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Special Warnings (if any) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Storage Condition | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Specific information in accordance with valid provisions, if any (e.g., source of porcine and alcohol contents) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Warning for limited over-the-counter drug (OTC) | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| With physician prescription only in the Indonesian language (for prescription drugs) | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Specific round mark of prescription drug/OTC/limited OTC | ✓ | ✓ | ✓ | ✓ | ✓ |
Health Supplement Registration: The Process
Health supplement registration starts with obtaining a Food Safety Management Certification or SMKPO. This certification ensures the safety and quality of food processing and is issued by The National Agency of Drug and Food Control (BPOM Indonesia).
After obtaining the Food Safety Management Certification, the facility where the product will be manufactured needs to be registered with BPOM. Then the main step is to register the product where the application for the specific product is submitted to BPOM. With our expertise in Indonesian regulations, we can provide food supplement registration services in Indonesia as seamlessly as possible.
