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Kamis, Januari 25, 2024

BPOM Set to Update Supervision Procedures for the Online Distribution of Food and Drugs

Pharmacies, Health Industry, and Foods & Drugs Standard

In order to ensure that the supervision of all food and drug products that are distributed online ("Products") is in line with current requirements, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan - "BPOM") is currently preparing a Draft Regulation on the Supervision of Drugs and Foods That Are Distributed Online ("Draft Regulation"). If it is ultimately enforced, then this new regulation will become the latest framework to address Products. Currently, these matters are still addressed under Regulation of BPOM No. 8 of 2020, which bears the same title as the Draft Regulation, as amended by Regulation of BPOM No. 32 of 2020 (collectively referred to as "Regulation 8/2020").
While maintaining the list of Products subject to BPOM supervision, as originally outlined under Regulation 8/2020, the Draft Regulation has now included drug materials and/or natural-ingredient drug materials onto the list and clarifies that processed foods now include food products that are intended for specific medical purposes (Pangan Olahan untuk Keperluan Medis Khusus/PKMK), as well as food additives (Bahan Tambahan Pangan/BTP).
Furthermore, the Draft Regulation also clarifies that the following parties will be deemed eligible to distribute Products through online channels: 1) Business actors that engage in the Products sector; and/or 2) Providers of electronic systems (Penyelenggara Sistem Elektronik - "PSE") and organizers of trading activities that are conducted via electronic systems (Penyelenggara Perdagangan Melalui Sistem Elektronik - "PPMSE"). The Draft Regulation also introduces a number of obligations that apply to PSE and PPMSE, including the following: 1) The obligation to actively supervise and evaluate all Products that are distributed online via electronic systems ("Systems"); 2) The obligation to block and/or close off access to Systems for any users that violate applicable laws and regulations; and 3) The obligation to verify and validate all System users and Products that are processed through Systems.
BPOM is currently soliciting input on the Draft Regulation until a deadline of 26 January 2024. Said inputs may be submitted via the following links: 1) For inputs on drugs, health supplements and cosmetics: https://bit.ly/Masukan-PBDaringOTSKK; and 2) For inputs on processed foods: https://standarpangan.pom.go.id/Konblik_Pengawasan_Obat_dan_Makanan_secara_Daring.

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In order to ensure that the supervision of all food and drug products that are distributed online ("Products") is in line with current requirements, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan - "BPOM") is currently preparing a Draft Regulation on the Supervision of Drugs and Foods That Are Distributed Online ("Draft Regulation"). If it is ultimately enforced, then this new regulation will become the latest framework to address Products. Currently, these matters are still addressed under Regulation of BPOM No. 8 of 2020, which bears the same title as the Draft Regulation, as amended by Regulation of BPOM No. 32 of 2020 (collectively referred to as "Regulation 8/2020").
While maintaining the list of Products subject to BPOM supervision, as originally outlined under Regulation 8/2020, the Draft Regulation has now included drug materials and/or natural-ingredient drug materials onto the list and clarifies that processed foods now include food products that are intended for specific medical purposes (Pangan Olahan untuk Keperluan Medis Khusus/PKMK), as well as food additives (Bahan Tambahan Pangan/BTP).
Furthermore, the Draft Regulation also clarifies that the following parties will be deemed eligible to distribute Products through online channels: 1) Business actors that engage in the Products sector; and/or 2) Providers of electronic systems (Penyelenggara Sistem Elektronik - "PSE") and organizers of trading activities that are conducted via electronic systems (Penyelenggara Perdagangan Melalui Sistem Elektronik - "PPMSE"). The Draft Regulation also introduces a number of obligations that apply to PSE and PPMSE, including the following: 1) The obligation to actively supervise and evaluate all Products that are distributed online via electronic systems ("Systems"); 2) The obligation to block and/or close off access to Systems for any users that violate applicable laws and regulations; and 3) The obligation to verify and validate all System users and Products that are processed through Systems.
BPOM is currently soliciting input on the Draft Regulation until a deadline of 26 January 2024. Said inputs may be submitted via the following links: 1) For inputs on drugs, health supplements and cosmetics: https://bit.ly/Masukan-PBDaringOTSKK; and 2) For inputs on processed foods: https://standarpangan.pom.go.id/Konblik_Pengawasan_Obat_dan_Makanan_secara_Daring.

......

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Semua Fitur Paket Professional
Layanan Penerjemahan Peraturan
Precedent Hukumonline
Virtual Discussion

PROFESSIONAL

Rp 4.500.000

per bulan

Semua Fitur Paket Standard
Terjemahan Peraturan
Peraturan Konsolidasi
Premium Stories
Monthly Law Review (MLR)
Indonesian Law Digest (ILD)

STANDARD

Rp 2.500.000

per bulan

Indonesian Legal Brief (ILB)
Daily Updates
Bantuan Layanan Pencarian Peraturan
Pusat Data Peraturan dan Putusan Pengadilan Non-Precedent

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