Registration of Food and Drugs
All food and drugs include traditional medicines, cosmetic, food supplement or processed food oblige to fulfil security requirement to enter Indonesia’s market. Registration of food and drugs ruled under BPOM one of which through Regulation of the Head of Indonesia Food and Drugs Authority No. 27 Year 2013 concerning Drugs and Imported Food Control to Indonesian Territory.
Registration of imported products must be made by local company, local agent or local distributor before it reach custom. Particularly for approval of cosmetic registration, Indonesia refers to the scheme of ASEAN Harmonized Cosmetic Regulatory.
For importing food one must attain registration number of Foreign Food (Makanan Luar) from BPO.M. The process or regular registration will take 2 to 3 months depend on the type of products. Each registration number will be renewed after 5 years.
For registering drugs, the guideline refers to ASEAN Common Technical Dossier (ACTD) in relevance to main documents such as GMP certificate, clinical study, stability study, and other additional documents. The registration of drugs will take 1 to 3 year process. In general, Indonesia will consider locally manufactured drugs compare to imported drugs.
