Kamis, Februari 15, 2024

BPOM Set to Revoke Framework on Electronically Integrated Business Licensing Service Within Food and Drugs Sector

The mandatory business licenses that apply within the food and drugs sector are currently addressed under Regulation of the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") No. 10 of 2021 on Standards for Business Activities and Products for the Organization of Risk-Based Business Licensing Within the Food and Drugs Sector ("Regulation 10/2021").
Given the existence of the above-mentioned regulatory framework, and also given that the previously introduced framework of Regulation of the BPOM No. 26 of 2018 on the Electronically Integrated Business Licensing Service Within the Food and Drugs Sector ("Regulation 26/2018") is no longer believed to be in line with the current legal landscape, BPOM is currently preparing a new Draft Regulation ("Draft Regulation"). If enforced, the Draft Regulation will ultimately repeal and replace Regulation 26/2018.
For more on Regulation 26/2018, see the following edition of Indonesian Legal Brief (ILB): “Integration of the Food and Sector Drug into the OSS System”.

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The mandatory business licenses that apply within the food and drugs sector are currently addressed under Regulation of the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") No. 10 of 2021 on Standards for Business Activities and Products for the Organization of Risk-Based Business Licensing Within the Food and Drugs Sector ("Regulation 10/2021").
Given the existence of the above-mentioned regulatory framework, and also given that the previously introduced framework of Regulation of the BPOM No. 26 of 2018 on the Electronically Integrated Business Licensing Service Within the Food and Drugs Sector ("Regulation 26/2018") is no longer believed to be in line with the current legal landscape, BPOM is currently preparing a new Draft Regulation ("Draft Regulation"). If enforced, the Draft Regulation will ultimately repeal and replace Regulation 26/2018.
For more on Regulation 26/2018, see the following edition of Indonesian Legal Brief (ILB): “Integration of the Food and Sector Drug into the OSS System”.

......