The Indonesian government has implemented a control system for medicines and food which is administered by the Food and Drug Supervisory Agency (Badan Pengawas Obat dan Makanan or BPOM).
As a result, all imported or locally-produced foods and beverages – as well as but not limited to cosmetics, medicines and complementary products – are required to be registered at the BPOM before they can be distributed in Indonesia.
This registration should be undertaken by a local business agent or partner. As the registration process in BPOM can be time-consuming, it is advisable for the exporter to allow for the finalization of the process prior to exporting the goods to Indonesia.
Three unique labels are applied to registered products in the market from the Division of Administration, Directorate of Food Safety Assessment, namely:
- Code ML:
ML or Makanan Luar (roughly translated as imported food) is granted to processed food and beverage products derived from imported products, either directly or repackaged. A registration number with the initial code “ML” is placed on the packaged of the imported food and drug product. The registration number remains valid as long as no changes occur to the composition process or the location of the processing plant.
- Code MD:
MD or Makanan Produksi Dalam Negeri (Domestically produced food) is granted to large capital food and beverage products tacitly considered to have the competence to comply with the food safety requirements set by the government. \
- Code SP:
SP or Sertifikat Penyuluhan (Counselling Certificate) is granted to small and medium enterprises that are receiving counseling assistance from their respective municipal health agency.
BPOM label procedure is regulated under BPOM Regulation No. 27/2018 regarding the supervision of food and drugs entry into Indonesia as well as BPOM regulation No.26/2018 regarding the BPOM e-licensing service.
The following are some of the administrative documents required to register a product to the BPOM:
- An application letter addressed to the corresponding Director (Drugs, Traditional Drugs, Cosmetics or Food and Beverages) signed by the company’s Director;
- The ownership of Importer’s Permit (Angka Pengenal Importir/API) for related products being applied for;
- The Authorization Letter from foreign principal;
- The Certificate of Good Manufacturing Practice (GMP);
- Copy of Trading License (Surat Ijin Usaha Perdagangan/SIUP);
- Copy of Taxpayer Identification Number (Nomar Pokok Wajib Pajak/NPWP)
- Industrial License for Pharmaceutical products;