Introduction to Registration and Permit for Domestic Health Supplement Businesses

Corporate Secretary Service Indonesia – People are increasingly aware of the importance of maintaining health for survival. Therefore, supplements are often considered as an effective way to fulfill nutritional needs or support various aspects of health. Nowadays, it is easy to find various types of health supplements sold in online stores or e-commerce. Therefore, prospective consumers should be more careful before buying.

One way is to check whether there is a distribution permit number registered with the Food and Drug Administration (BPOM). Health supplements that do not have a distribution permit can be said to be illegal supplements, so they have the potential to be dangerous because they are not checked by BPOM first. The distribution permit for health supplements is regulated in BPOM Regulation Number 32 of 2022 concerning Criteria and Procedures for Registration of Health Supplements (BPOM Regulation 32/2022). So, what are the further provisions of the health supplement distribution permit?

Registration of Health Supplements Made Independently by Business Actors

The business actors in question consist of the pharmaceutical industry, traditional medicine industry (IOT), traditional medicine small businesses (UKOT), or the food industry. The document requirements to apply for a distribution permit made independently by business actors include (Article 23 paragraph (3) of BPOM Regulation 32/2022):

1. Taxpayer Identification Number TIN or NPWP in Indonesia;
2. Certificate of Good Manufacturing Practice / license to apply Good Manufacturing Practice in accordance with the form and type of preparation for which registration will be submitted, including:
3. CPOB certificate;
4. CPOTB certificate; or
5. CPPOB Implementation Permit and approval to produce Health Supplements in food production facilities.
6. Power of attorney of the person in charge of the account from the head of the company; and
7. Notarial deed of company establishment.

Read Also: 5 Criteria for Foreigners to Have a Place of Business in Indonesia

Contract-Based Registration

Business actors who become contractors here consist of the pharmaceutical industry, IOT, UKOT, food industry, or business entities in the field of marketing health supplements. Document requirements needed to apply for a distribution permit based on a contract include (Article 24 paragraph (6) of BPOM Regulation 32/2022):

1. NPWP;
2. Certificate of Good Manufacturing Practice/permit to implement Good Manufacturing Practice, including:
3. CPOB certificate;
4. CPOTB certificate; or
5. CPPOB Implementation Permit and approval to produce Health Supplements in food production facilities.
6. A valid production contract cooperation agreement document, and provide:
7. The pharmaceutical industry, IOT, or UKOT already has a Good Manufacturing Practice Certificate; or
8. The food industry already has a CPPOB Implementation Permit in accordance with the dosage form to be registered and an approval document to produce health supplements in food production facilities.

License-based Registration

The business actors in question are the pharmaceutical industry, IOT, UKOT, and the food industry. They act as licensees here. The submission of an application for distribution permit registration is carried out by the licensee based on the license granted by:

1. Industry abroad; or
2. Research institutions that own formulas and technologies at home or abroad.

Document requirements that must be met by the licensee for distribution permit registration include (Article 30 paragraph (5) of BPOM Regulation 32/2022):

1. Certificate of Good Manufacturing Practice/permit to apply Good Manufacturing Practice in accordance with the form and type of preparation to be licensed, including:
2. CPOB certificate;
3. CPOTB certificate; or
4. CPPOB Implementation Permit and approval to produce Health Supplements in processed food production facilities.
5. License agreement document; and
6. Certificate of Free Sale (CFS) or Certificate of Pharmaceutical Product (CPP), or other equivalent documents issued by the competent government authority in the country of origin or other institutions appointed by the government of the country of origin with proof of attaching a letter of appointment.

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