In Indonesia, the National Agency of Drug and Food Control of Republic of Indonesia or NADFC (Indonesian: Badan Pengawas Obat dan Makanan) or Badan POM (BPOM), a government agency of Indonesia is responsible for the supervision of prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, dietary supplements, food safety and cosmetics. Food Law No. 18/2012 regulates all food and food products, defined as all food which originates from biological agricultural sources. Law 18/2012 also states that the food supplies should always be enough, safe, high quality, diverse, affordable, and may not conflict with religion, beliefs and culture.
The Government of Indonesia (GOI) notes that Indonesia requires Food Systems that will provide protections for producers, as well as consumers of food. The National Agency for Drug and Food Control (BPOM) or NADFC maintains that it is necessary for Indonesia to focus on the pre-market control. The food safety control system in Indonesia requires a broad range of pre-market and post-market control. Pre-market controls are conducted by evaluating the food safety of products to ensure the compliance with safety and quality requirements prior to retail. If a product meets the necessary requirements, the product is provided with a registration approval number and it becomes eligible for retail market. Post-market control is conducted after food products have been distributed in the market and/or retail outlets.
To enter the Indonesian food and food supplement market compliantly, Freyr provides end-to-end Regulatory assistance for manufacturers.
- Product Classification
- Formula Review/Ingredients Assessment
- Label and Claims review
- Compilation and Submission of Dossier to Health Authority (BPOM)
- Follow ups and meetings with BPOM till Product registration
- Legal Representation services
- Regulatory Intelligence
- Local Language labeling support
End-to-end Regulatory consultation and Registration Support for Indonesia
Strong Legal Representation for Indonesia
Sample testing facilitation for BPOM
Qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc
Support for region-specific Regulatory activities
Extensive partner network across the globe
Strong relationship with different health authorities
Structured and cost-effective approach to ensure speed to market