The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan – “BPOM”) has issued Regulation No. 2 of 2022 on the Reporting of Pharmaceutical Industries’ and Pharmaceutical Wholesalers’ Activities (“BPOM 2/2022”) which sets out a number of new reporting obligations to pharmaceutical industries and pharmaceutical wholesalers (Pedagang Besar Farmasi – “PBF”).

The reports that should be submitted by pharmaceutical industries are reports on (i) the entry and use of active drug ingredients (ii) the production and distribution of drugs (iii) the production and distribution of active drug ingredients; (iv) the realization of imports and exports of drugs and medicinal ingredients; and (v) pharmaceutical industry data, including information relating to or the profiles of the relevant pharmaceutical industries, including any production activities and production equipment used.

Meanwhile, PBF and branches of PBFs are required to submit reports on (i) the entry and distribution of active drug ingredients (ii) the entry and distribution of drugs, and (iii) the realization of imports and exports of drugs and medicinal ingredients.

BPOM 2/2022 regulates that each of the reports should be submitted to the Head of the BPOM within a specific time schedule and submitted in electronic form via BPOM’s operated website for the reporting of activities of pharmaceutical industries and PBFs which currently may be accessed through

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