Indonesian FDA published regulation No. 26 of 2022 to regulate importation of drugs and food materials

The food and drug control agency has decided to regulate the import of medicinal and food materials into Indonesia, carrying out supervisory duties before and during distribution. This regulation includes additional regulations on the entry of certain drug materials through the post border import notification letter (Surat Keterangan Import) mechanism, the adjustment of special access scheme mechanisms under Indonesia FDA supervision, the provision of importation realization reports submitted by business operators, and the addition of several drug materials to the list of drug materials attachments supervised by Indonesia FDA.
Health supplement materials, quasi drug materials, cosmetics materials, and/or food ingredients must have SKI post border no later than 7 days from the issuance date of the goods release letter issued by the competent authority. Applicants for border import certificate (SKI border) or SKI post border must have NIB through online single submission to obtain login access at the food and drug supervisory agencies in-house. Traditional and SKI post border health supplement materials must be accompanied by health, origin, reporting, and other certificates/certifications. Border SKI applicants must also be accompanied by a certificate of good manufacturing practice (GMP) owned by the producer of the drug substance.