Revised Regulation on the Non-Tax State Revenue at the National Agency of Drug and Food Control

The types and tariffs of Non-Tax State Revenue (‘PNBP’) at the National Agency of Drug and Food Control (‘BPOM’) have since 2001 been regulated by Government Regulation No. 17 of 2001 (“2001 Regulation”). Nevertheless in its development, there are a number of new types and changes to the tariff rates. In order to coordinate with the prevailing development, the government recently revised the 2001 Regulation through Government Regulation No. 48 of 2010 (“Regulation”).

The Regulation provides 9 types of PNBPs at the BPOM – introducing 6 new types of PNBPs on top of the previous 3 (i.e. revenues from registration and evaluation, certification, and examination). The new PNBPs include BPOM’s proceeds deriving from the inspection of imported products’ production facilities, calibration, laboratory training, proficiency tests, the selling of animal experiments, and drug and food-related research cooperation with other parties.

Except for the revenues gained from research cooperation, the types and their tariff rates of the PNBPs at the BPOM are laid down in details in Attachment to the Regulation. It must be noted that some types of PNBPs remain the same, although their tariff rates have been altered. For example, whereas previously charged at IDR 500,000 per item, the registration of dairy products is now charged at IDR 750,000 per item.

The reason that revenues received by BPOM from research cooperation with its counterpart are not listed in Attachment to the Regulation along with the other PNBPs is because the amount of revenues from such activity may vary depending on the negotiation process between the BPOM and its research partner(s). Thus, according to Article 1 (3) of the Regulation, the tariff rates of PNBP from research cooperation will be determined based on the amount as set out in the partnership contract between the BPOM and its research counterpart(s).

In addition, the Regulation waives certain BPOM service fees from being charged to any applicant that is otherwise mandatory and considered as an PNPB at the BPOM. This service is the examination service. Article 4 of the Regulation stipulates that for the examination service by the BPOM there will be imposed a tariff in the amount of IDR 0,00 [sic] in the event that an extraordinary event or a calamity takes place.

“Extraordinary event or calamity”, however, are not clearly defined by the Regulation. Elucidation of Article 4 of the Regulation only refers the meaning of extraordinary event or calamity to the [existing, relevant] regulations.

The Regulation repeals and replaces the 2001 Regulation, and has been in force since 25 May 2010.