Regulation Revision: BPOM to Prohibit Distributors from Submitting Application for Assessment

Distributors of raw materials for Natural Medicine (Obat Bahan Alam – “OBA”) will no longer be able to submit applications for safety and quality assessment of medicines to the Drug and Food Supervisory Agency (Badan Pengawas Obat dan Makanan – “BPOM”). This change is regulated in the draft amendment to BPOM Regulation No. 29 of 2023 on the Safety and Quality Requirements for Natural Medicine (“PerBPOM 29/2023”).

“There is an addition stating that business actors may submit an application for assessment, except for suppliers of OBA raw materials,” said Dian Putri Anggraweni, Director of Traditional Medicine, Health Supplement, and Cosmetics Standardization.

The prohibition was introduced to prevent distributors from making claims when selling raw materials. According to Putri, many distributors are not registered with BPOM, yet they often conduct safety and quality assessment of medicines.