The Overview of Food Supplement in Indonesia
Indonesia is one of the ASEAN member countries which decided to adopt the terminology in ASEAN harmonization regulations on Traditional Medicines and Health Supplements (TMHS). Under this regional harmonization framework, health supplement in Indonesia is registered to separate directorate named Directorate of Health Supplement Evaluation under BPOM.
Based on ASEAN Agreement on Traditional Medicines and Health Supplements (TMHS) article 2, product which is categorized as health supplement is any product that is used to supplement a diet and to maintain, enhance and improve the healthy function of human body and contains one or more or combination of vitamin, mineral, amino acids, fatty acids, enzymes, substance derived and synthetic sources of above ingredients.
However, Indonesia have its own definition for health supplement as complement the nutritional need, maintain, increase and improve health function, containing one or more ingredients in the form of vitamin, mineral, amino acid or other ingredient (originating from plant or non-plant) that have nutritional value and/or physiological effect, not intended as food.
However, this health supplement definition is not the single standard to categorize the product as health supplement or goes to another categorization. The categorization will instead depend on the ingredients in each product.
Health and Food Supplement Registration in Indonesia
In Indonesia, health supplement is regulated through Regulation of the Head of the Agency of Drug and Food Control Republic of Indonesia Number HK.00.05.41.1381 concern The Standard Procedure of Food Supplement Registration. Procedure to register health supplement in Indonesia is divided into 2 steps:
- Pre-assessment as step for the evaluator to check the completeness of required documents and to determine the categorization of registration. The pre-assessment may take 20 working days to get the result.
- Assessment as the next step to conduct the evaluation based on documents and supporting data.
In health supplement registration, one product with different size is considered as one registration only but if for example one product have 4 different flavors in different bottle, it is considered as one flavor as one product. During the registration, there is certain fee is charged in accordance with the prevailing statutory regulations.
Following pre-assessment and assessment is not the guarantee if the application is approved. In this case there is refusal possibility due to the incomplete documents or other factors and the payment term is non-refundable. The documents which are required as below:
- Import license from importer
- Letter of Authorization from manufacturer
- Certificate of Free Sale issued by the Government of country origin which legalized by Indonesian embassy/ Consulate General in that country origin
- Good Manufacturing Practice from the manufacturer
- Company Tax ID (NPWP)
- Trade Business License
- Ingredients which includes details composition in matrix both active ingredients and additive, direction of usage (direction, dosage, warning, contraindication and other necessary information )
- Manufacturing process from weighing of raw materials to finished products
- Method and result of stability study (Indonesia, zone IV, RH: 75% + 5%, T: 30oC +2oC, minimum 6 months and 2 batch)
- Certificate of safety test from laboratories appointed by BPOM for organoleptic, physical-chemical, microbial, heavy metal, chemical drug and psychotropic-narcotic contaminant.
- Data of toxicity test from laboratories appointed by BPOM or equivalent body in country of origin for health supplement which its safety is not yet known
The assessment process approximately takes 6 months until 1 year to get the final result. The registration approval for food supplement is valid for five years as long as still meeting the prevailing provisions and can be extended through re-registration.
Cekindo Can Help You
You can register the food supplements directly under your own company.
But if you are not ready yet to set up a company, you can register your products under Indonesian local company. Cekindo can help you to be the 3rd party so you can register the products safely under our company.