{"id":9474,"date":"2024-03-14T03:01:40","date_gmt":"2024-03-13T20:01:40","guid":{"rendered":"https:\/\/investinasia.id\/blog\/?p=9474"},"modified":"2024-10-31T16:32:34","modified_gmt":"2024-10-31T09:32:34","slug":"health-and-food-supplement-registration-in-indonesia","status":"publish","type":"post","link":"https:\/\/investinasia.id\/blog\/health-and-food-supplement-registration-in-indonesia\/","title":{"rendered":"Health and Food Supplement Registration in Indonesia"},"content":{"rendered":"

In today’s health-conscious world, more people are turning to health supplements to fulfill their nutritional needs and enhance their well-being. This trend has not gone unnoticed by international investors, particularly in countries like Indonesia, where the health supplement market is booming. If you’re considering expanding your business into Indonesia, understanding the regulations and procedures for registering health and food supplements is crucial.<\/p>\n

In this article, we’ll delve into the intricacies of health and food supplement registration services in Indonesia, exploring the regulations, procedures, and requirements involved.<\/p>\n

Also read:<\/strong> What Is BPOM in Indonesia: Its Role and Regulation<\/a><\/strong><\/p>\n

Regulation of Health and Food Supplement Registration in Indonesia<\/h2>\n
\"Health
Health and Food Supplement Registration in Indonesia<\/figcaption><\/figure>\n

In Indonesia, the regulation of therapeutic products, narcotics, psychotropic and addictive substances, traditional medicines, cosmetics, health supplements, and food safety is overseen by the National Agency of Drug and Food Control, also known as Badan Pengawas Obat dan Makanan (BPOM).<\/p>\n

As per Regulation No. 27\/2017 of the BPOM, food encompasses biological products from agriculture, plantations, forestry, fisheries, livestock, and water, whether processed or unprocessed, for human consumption. Regulation No. 11\/2020 defines food supplements as ‘health supplements,’ intended to fulfill nutritional needs and maintain, enhance, or improve health functions, comprising vitamins, minerals, amino acids, and\/or other non-plant ingredients.<\/p>\n

The control of drugs and food in Indonesia is complex, prompting the establishment of a comprehensive pre-market and post-market monitoring system by BPOM. Pre-market assessment ensures compliance with safety and quality standards before retail, while post-market control monitors products already in circulation.<\/p>\n

Also read:<\/strong> BPOM Indonesia Food Regulation<\/a><\/strong><\/p>\n

Registration Category<\/h2>\n

Based on Regulation of The BPOM No. HK.00.05.41.1381, the registration of food supplements is categorized into new registration and variation registration.<\/p>\n

New Registration<\/h3>\n

Category 1:<\/strong><\/p>\n

Registration of food supplements containing one or more ingredients such as vitamins, minerals, amino acids, carbohydrates, proteins, fats, or other isolates;<\/p>\n

Category 2:<\/strong><\/p>\n

Registration of food supplements containing one or more ingredients such as vitamins, minerals, amino acids, carbohydrates, proteins, fats, other isolates, and natural ingredients;<\/p>\n

Category 3:<\/strong><\/p>\n

Registration of food supplements from categories 1 and 2 with claims of new usage, new dosage form, new dosage, and new dosing regimen.<\/p>\n

Variation Registration<\/h3>\n

Category 4:<\/strong><\/p>\n

Registration of food supplements that have obtained marketing authorization with:<\/p>\n

    \n
  1. Product name change without composition change;<\/li>\n
  2. Change or addition of packaging size;<\/li>\n
  3. Changes in labeling claims that do not alter benefits;<\/li>\n
  4. Packaging design changes;<\/li>\n
  5. Factory name or licensor name change without change in ownership status;<\/li>\n
  6. Importer name change without change in ownership status.<\/li>\n<\/ol>\n

    Category 5:<\/strong><\/p>\n

    Registration of food supplements that have obtained marketing authorization with:<\/p>\n

      \n
    1. Changes in specifications and\/or raw material analysis methods;<\/li>\n
    2. Changes in specifications and\/or finished product analysis methods;<\/li>\n
    3. Stability changes;<\/li>\n
    4. Production technology changes;<\/li>\n
    5. Production location changes;<\/li>\n
    6. Packaging changes or additions.<\/li>\n<\/ol>\n

      Category 6:<\/strong><\/p>\n

      Registration of food supplements that have obtained marketing authorization with:<\/p>\n

        \n
      1. Formula change, or composition where the main ingredients belong to one group;<\/li>\n
      2. Addition of supplementary ingredients that do not alter benefits.<\/li>\n<\/ol>\n

        Also read:<\/strong> What is KBLI in Indonesia: Complete Guide for Foreigner<\/a><\/strong><\/p>\n

        Health Supplement Registration Procedure in Indonesia<\/h2>\n
        \"Health
        Health and Food Supplement Registration in Indonesia<\/figcaption><\/figure>\n

        Pre-Assessment<\/h3>\n

        The registration process typically involves two main steps, beginning with pre-assessment. During this stage, documents are evaluated for completeness, and the registration categorization is determined. This initial phase usually takes around 20 working days.<\/p>\n

        Assessment<\/h3>\n

        Following pre-assessment, the formal assessment of documents and supporting data takes place. This step is crucial for evaluating the safety and quality of the health supplements. It’s important to note that completion of pre-assessment and assessment does not guarantee approval, as refusal may occur due to incomplete documentation or other factors, with non-refundable payment terms.<\/p>\n

        Requirements for Health and Food Supplement Registration<\/h2>\n

        Mandatory Documentation<\/h3>\n

        Several documents are required for health and food supplement registration in Indonesia, including:<\/p>\n