Food Supplements Registration in Indonesia - Overview
In Indonesia, the National Agency of Drug and Food Control (NADFC), also known as Badan Pengawas Obat dan Makanan (BPOM), Badan POM, or the Indonesian FDA, is a government agency is responsible for the supervision of therapeutic products, narcotics, psychotropic and additive substances, traditional medicines, cosmetics, health supplements, and food safety.
Under Regulation No. 27/2017 of the BPOM, food is defined as anything that is sourced from biological products from agriculture, plantations, forestry, fisheries, livestock, and water. The source can be both processed and unprocessed and can be designated as foods or drinks for human consumption, including food additives, food raw materials, and other materials used in the preparation process, processing, and/or manufacture of foods or drinks.
Under Regulation No. 11/2020 of the BPOM, Indonesia food regulation, food supplements are termed ‘health supplements’. They are defined as products intended to meet nutritional needs and maintain, enhance, and/or improve health functions. They must have nutritional value and/or physiological effects and should contain one (01) or more ingredients in the form of vitamins, minerals, amino acids, and/or other non-plant ingredients that can be combined with plants.
Drug and food control in Indonesia is ridden with a wide range of problems and complexities. Therefore, BPOM, under Indonesia food regulations, has established a comprehensive monitoring system for pre-market and post-market control. Pre-market controls are conducted by evaluating food and food supplements to ensure compliance with safety and quality requirements prior to retail. If a product meets the requirements, it is provided with a registration approval number, and it thereby becomes eligible for the retail market. Post-market control is conducted after food and food supplements have been distributed in the market and/or the retail outlets.
Freyr provides end-to-end Regulatory assistance in food supplements registration in Indonesia to the manufacturers to enter and navigate through the Indonesian food and food supplement market in a compliant manner.
Food Supplements Registration in Indonesia - Freyr Expertise
- Product Classification.
- Formula Review/Ingredients Assessment.
- Label and Claims Review.
- Compilation and Submission of Dossier to the Health Authority, that is, BPOM.
- Follow-up and Meetings with BPOM until Product Registration.
- Legal Representative (LR) Services.
- Regulatory Pathway Reports.
- Local Language Labeling Support.
Food Supplements Registration in Indonesia - Freyr Advantages
End-to-end Regulatory consultation and BPOM registration support for Indonesia.
Strong legal representation for Indonesia.
Sample testing facilitation for BPOM Registration.
A qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, Health Functional Foods (HFFs), health functional beverages, Foods for Special Dietary Use (FSDU), etc.
Support in region-specific Regulatory activities.
An extensive partnership network across the globe.
A strong relationship with different Health Authorities (HAs).
A structured and cost-effective approach to ensure quick entry into the market.