Food and Food Supplements Regulatory Services in Indonesia

Food and Food Supplements
Regulatory Services in Indonesia

Overview

In Indonesia, the National Agency of Drug and Food Control of the Republic of Indonesia or NADFC Food (Indonesian: Badan Pengawas Obat dan Makanan) or Badan POM, the National Agency for Drug and Food Control (BPOM), a Government Agency of Indonesia, is responsible for the supervision of therapeutic products, narcotics, psychotropic, addictive substances, traditional medicines, cosmetics, health supplement, food safety.

According to the National Agency for Drug and Food Control (BPOM), under Regulation No. 11/2020, food supplements are termed as health supplements. They are defined as products intended to meet nutritional needs, maintain, enhance and/or improve health functions. They must have nutritional value and/or physiological effects contain one or more ingredients in the form of vitamins, minerals, amino, acids and/or other non-plant ingredients which can be combined with plants.

According to BPOM regulation no.27/2017, food is defined as anything that comes from a source of biological products from agriculture, plantation, forestry, fisheries, livestock, and water. The source can be both processed or unprocessed and are 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.

Drug and food control has a wide range of problems and complexities. Therefore, BPOM has established a comprehensive monitoring system for pre-market and post-market control. Pre-market controls are conducted by evaluating the food and food supplements to ensure compliance with safety and quality requirements prior to retail. If a product meets the necessary requirements, it is provided with a registration approval number and becomes eligible for the retail market. Post-market control is conducted after food and food supplements 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.

Expertise

Freyr Expertise

  • Product Classification
  • Formula Review/Ingredients Assessment
  • Label and Claims Review
  • Compilation and Submission of Dossier to Health Authority (BPOM)
  • Follow-up and Meetings with BPOM till Product Registration
  • Legal Representative Services
  • Regulatory Intelligence
  • Local Language Labeling Support
Freyr Advantages

ADVANTAGES

Freyr Advantages

 

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