Drug Materials, Traditional Drug Materials, Cosmetic Materials, Health Supplement Materials, Food Materials.

Indonesian FDA Regulation No. 26 of 2022 on Supervision of the Importation of Drug and Food Materials into Indonesian Territory; (23 page(s), in Indonesian)

This regulation is the amendments to Indonesian FDA Regulation No. 29 of 2017 on Supervision of the Importation of Drug and Food Materials into Indonesian Territory. New provisions changed on this regulation include:

a.    Additional regulation on the entry of certain drug materials (Propylene Glycol, Polyethylene Glycol and other materials with limited levels of Ethylene Glycol and Diethylene Glycol for pharmaceutical grade) through Post Border Import Notification Letter (Surat Keterangan Impor) mechanism.

b.    The amendment of the operational definition of Border Import Notification Letter and Post Border Import Notification Letter.

c.     The adjustment of Special Access Scheme mechanism under Indonesia FDA supervision such as for Biological Products; Research Drugs (excluding Biological Products, narcotics, psychotropics and pharmaceutical precursors); and Drug Materials.

d.    The amendment of the provision of importation realization report submitted by business actors.

e.    The addition of several drug materials to the list of drug materials attachments which is supervised by Indonesia FDA.