Indonesia Issues New Regulation Regarding Supervision on Health Supplements Circulation

On July 21, 2023, Indonesia BPOM published Regulation of the Food and Drug Supervisory Agency Number 16 of 2023 Concerning Supervision of Circulation of Traditional Medicines, Quasi Medicines, and Health Supplements. To protect the public from products that do not meet safety and quality requirements circulating in the Indonesian market, this regulation sets out the requirements for health supplement products, as well as the responsibilities of circulation permit holders, and (overseas) product producers respectively. Details are as follows:

Overall, the supervision on the circulation of health supplement products is conducted by BPOM officials through regular and random inspections targeting circulation facilities and products. Any violations may be subject to the following administrative penalties:

• warning;

• termination of the circulation of the related products;

• destruction of the related products;

• suspension of administrative approval process of health supplements circulation;

• revoke of administrative approval of health supplements.

Supervision on Health Supplement Products 

The inspection of health supplement products covers the following aspects:

• circulation permit;

• products listed in public announcements;

• expired products;

• damaged products;

• products not in accordance with what is registered;

• counterfeit products;

• products suspected of containing medicinal chemicals;

• unapproved markings;

• products withdrawn from circulation;

• unapproved promotion and advertisement;

• products containing ingredients that are prohibited for used in traditional medicines, quasi-medicines, and/or health supplements.

Supervision on Circulation Permit Holders  

Circulation permit holders of health supplements include local producers, business operators and importers. Being responsible for related locally-produced or imported health supplements, they are required to guarantee the followings:

• products for sale to have circulation permit numbers;

• products not forbidden by BPOM to be circulated in the Indonesian market;

• products to meet related safety, quality and labeling requirements;

• products not damaged;

• products' expiration periods in accordance with those in circulation permits.

In particular, the inspection of importers will focus on the following items:

• administration documents for licensing;

• technical documents of business activities;

• storage and/or distribution facilities; and

• qualifications of the technical person in charge.

Supervision on Health Supplement Producers 

Not only Indonesian producers who have accepted the contract for health supplement production, but also overseas producers whose health supplement products are sold in the Indonesian market, are subject to the BPOM inspection. The inspection covers two major aspects, namely, administrative documents, and the fulfillment of good storage and shipping practices.

For the full English version of this regulation, please feel free to contact us.