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Indonesia established standards and procedures for the registration of health products

BPOM Badan Pengawas Obat dan Makanan印度尼西亚食品药品监督管理局Indonesian Food and Drug Authority or Agency for Drug and Food Control or Indonesian FDA.png

On 26 December 2022, the Indonesian Food and Drug Administration (BPOM) issued document No. 32 2022, setting out the standards and procedures for the registration of health products, which will be implemented from the date of issuance. The main contents are as follows:


(1) Definition of terms. 37 definitions of health care product registration, sales license, importer, etc;


(2) Requirements. Safety, hygiene, quality standards, labelling in accordance with the standards of the Indonesian Pharmacopoeia; Health care products may contain active ingredients or other ingredients. Active ingredients are derived from plants, and information on plant origin, preparation methods and testing methods must be provided. Non-plant origin ingredients must be accompanied by certification materials. Other ingredients (including preservatives, sweeteners, etc.) meet the requirements of regulations;


(3) Label requirements. Firmly paste or print directly on the package to prevent damage by water, friction or light. There should be a generic name or product name, dosage form, importer, manufacturer company name address, content and net weight, product composition (including additives), contraindications, side effects and warnings, batch number, shelf life, storage conditions, two-dimensional code, etc.;


(4) Other provisions. The nutrient content must be consistent with the results of laboratory tests in Indonesia;


(5) Registration of health care products. import registration: provide importer name and taxpayer identification number, proxy letter, name address of foreign production enterprises, product name specifications, etc., production authorization certificate issued by the official organization of the country of origin, good production practice certificate, free sale certificate, product testing report and other document requirements.


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