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On December 26, 2022, Indonesia Food and Drug Administration (BPOM) unveiled Criteria and Administration of Health Supplement Registration, which stipulated the registration requirements for and procedures of locally-produced, imported and exported health supplements. It replaced the previous 2020 version, and came into force immediately after its promulgation. Notably, BPOM provided a two-year transition period for stakeholders to adopt the changes. During the transition period, current circulation licenses remain valid. The details are as follows:
1. Product Requirements
Specific product requirements for health supplements are stipulated in Chapter 2 of this regulation. In addition, business operators (e.g., manufacturers, importers and distributors) are obliged to ensure the compliance of locally-produced and imported health supplements with related Indonesian regulations regarding product safety, efficacy, quality, advertising, claiming and labeling. Besides, the followings can be referenced:
For the quality requirements, please check Health Supplement Quality Requirements for more details.
For the advertising requirements, please check Advertising Supervision of Traditional Medicines, Quasi Medicines, and Health Supplements for more details.
For the claiming requirements, please check Guidelines for Claiming Health Supplements for more details.
For the labeling requirements, please check Annex 1 of this regulation.
2. Product Registration
In Indonesia, in order to obtain the circulation license of health supplements, business operators are required to register the products with BPOM and apply for the circulation license. For imported products, the applicants shall be importers. Locally-produced, imported and exported products are subject to different registration requirements. Besides, there are three types of registration of health supplements, namely, new registration, registration alteration and re-registration. In principle, the circulation license shall be valid for five years, and shall be prolonged via re-registration.
For the specific registration procedures, please check Chapter 3 of this regulation.
For the specific document requirements for product registration, please check Annex 2, 3 and 4 of this regulation.
3. Forbidden Products
According to this latest regulation, seven kinds of health supplements are forbidden to be circulated in the Indonesian market, which means they cannot be registered with BPOM. They are listed as follows:
a. products in the form of injections, eye drops and external preparations;
b. products with vitamins, minerals, amino acids and other ingredients that are beyond the maximum limits stated in Annex 7 of this regulation;
c. products with forbidden ingredients stated in Annex 8 of this regulation;
d. oral liquid products containing alcohol with concentration greater than 1%;
e. products containing drugs, pharmaceutical chemicals, intoxicating agents or psychotropic substances;
f. products containing animals and/or plants protected according to laws and regulations;
g. products failed to meet related standards on the basis of evaluation results from BPOM.
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