What Documents Must Be Attached When Registering Imported Cosmetics, and What Is the Procedure?

Under point E of Part II.3 of Annex II to Indonesia BPOM Head Regulation No. 39 of 2013 on the public-service standards of the Food and Drug Supervisory Agency, as amended by Head Regulation No. 15 of 2016, the following requirements must be met when submitting a cosmetics notification application to BPOM. 1. Administrative documents for imported cosmetics. 2. Taxpayer Identification Number (NPWP). 3. A valid Importer Identification Number (API). 4. A valid letter of agency appointment, stating the period of validity in the country of origin. 5. A certificate or statement issued by a competent government official or agency in the country of origin and authenticated by the Indonesian Embassy/Consulate General, indicating that the cosmetics factory in the country of origin has implemented Good Manufacturing Practice (GMP) according to the dosage form to be notified (for factories located in countries outside ASEAN, certification and legalization by the Indonesian Embassy/Consulate are required). 6. For factories located in ASEAN countries, a GMP certificate or a statement on GMP implementation issued according to the dosage form to be notified. 7. A Certificate of Free Sale (CFS) issued by a competent official in the country of origin and authenticated by the Indonesian Embassy or Consulate General (specifically for imports from countries outside ASEAN). 8. Technical documents: a) qualitative and quantitative formula; c) supporting materials for efficacy claims (if required); d) product samples (if required); e) a complete Product Information File (PIF) kept by the applicant. The PIF must be available at all times for assessment/audit by the Food and Drug Supervisory Agency.