Introduction to the Registration of Dietary Supplements in Indonesia

Corporate Secretary Service Indonesia – Indonesia is one of the ASEAN member states that decided to adopt the terminology in the ASEAN harmonized regulation on Traditional Medicines and Health Supplements (TMHS). Under this regional harmonization framework, health supplements in Indonesia are registered to a separate directorate called the Directorate of Additional Health Evaluation under BPOM.

Based on the ASEAN Agreement on Traditional Medicines and Health Supplements (TMHS) article 2, products categorized as health supplements are any products used to supplement the diet and to maintain, enhance and improve the healthy functioning of the human body and contain one or more or a combination of vitamins, minerals, amino acids, fatty acids, enzymes, derived substances and synthetic sources of the above ingredients.

However, Indonesia has its own definition for health supplements or dietary supplement as a complement to nutritional needs, maintaining, enhancing and improving health functions, containing one or more ingredients in the form of vitamins, minerals, amino acids or other ingredients (of plant or non-plant origin) that have nutritional value and/or physiological effects, not intended as food.

However, this definition of health supplements is not the sole standard for categorizing a product as a health supplement or into another categorization. The categorization will instead depend on the ingredients in each product.

Registration of Health and Food Supplements in Indonesia

In Indonesia, health supplements or dietary supplement are regulated through the Regulation of the Head of the Indonesian Food and Drug Administration Number HK.00.05.41.1381, which focuses on the Standard Procedures for Supplementary Registration of Food. The procedure to register health supplements in Indonesia is divided into 2 steps:

• Pre-assessment is a step in which the evaluator checks the completeness of the required documents and determines the categorization of the registration. The initial assessment may take 20 working days to get the result.
• Assessment is the next step in conducting an evaluation based on supporting documents and data.

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In health supplement registration, one product with different sizes is considered as one registration only. Still, suppose, for example, one product has 4 different flavours in various bottles. In that case, it is regarded as one flavor as one product. During registration, specific fees are charged in accordance with applicable laws and regulations. Following pre-assessment and review does not guarantee the application will be approved. In this case, rejection is possible due to incomplete documents or other factors, and the payment term is non-refundable. The records required are as follows:

Administrative Documents

• Import license from the importer
• Power of Attorney from the manufacturer
• Certificate of Free Sale issued by the Government of the country of origin legalized by the Indonesian embassy / Consulate General in that country of origin
• Good Manufacturing Practice from the manufacturer
• Taxpayer Identification Number (NPWP)
• Trade Business License (SIUP)

Technical Document

• Ingredients that include details of the composition in the matrix of both active and addictive ingredients, as well as direction of use (direction, dosage, warnings, contraindications, and other necessary information).
• Manufacturing process from raw material weight to finished product.
• Stability study methods and results (Indonesia, zone IV, RH: 75% + 5%, T: 30oC + 2oC, minimum 6 months and 2 batches).

Additional Documents

• Safety test certificates from laboratories appointed by BPOM for organoleptic, physical-chemical, microbial, heavy metal, chemical drug and psychotropic-narcotic contaminants.
• Toxicity test data from a laboratory designated by NA-DFC or equivalent body in the country of origin for health supplements or dietary supplement whose safety is unknown.

The assessment process takes approximately 6 months to 1 year to get the final result. Registration approval for this dietary supplement is valid for five years as long as it meets the applicable provisions and can be extended through re-registration.

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