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Rabu, September 20, 2023

BPOM Set to Revise Mechanism for Supervision Result Analyses of Imports and Exports of Narcotics, Psychotropics and Pharmaceutical Precursors

Pharmacies, Health Industry, and Foods & Drugs Standard

Indonesia’s Food and Drug Supervisory Agency (Badan Pengawas Obat dan Makanan – "BPOM") is currently preparing a Draft Regulation ("Draft Regulation") that will adjust various matters relating to the applicable requirements and procedures for the submission of applications for Analyses of Supervision Results (Analisa Hasil Pengawasan – "AHP") for Narcotics, Psychotropics and Pharmaceutical Precursors (collectively referred to as "Drugs"), as originally set out under Regulation of the BPOM No. 26 of 2020 ("Regulation 26/2020"). In this regard, inputs that specifically address the Draft Regulation may be submitted to BPOM by members of the general public until a deadline of 25 September 2023 through the following official link: http://bit.ly/FormatMasukanPERBPOM.
While the Draft Regulation still refers to the permitted purposes that underlie imports and exports of Drugs, the forthcoming framework has now removed the explicit obligation for AHP applicants for imports and exports of narcotics to be state-owned pharmaceutical wholesalers (Pedagang Besar Farmasi – "PBF"), as is currently the case under the framework of Regulation 26/2020. However, all narcotics importers and exporters must first secure special permits for these activities from the Minister of Health.
In addition to the currently applicable AHP application submission regime that is processed through BPOM’s official website for AHP services, the Draft Regulation now states that AHP applications may also be submitted through the Indonesian National Single Window System ("SINSW"). Moreover, the Draft Regulation classifies the various required documents for submissions of AHP applications as those that apply to pharmaceutical industries, those that apply to PBF (which specifically encompass eight types of documents) and those that apply to scientific institutions (which specifically encompass two types of documents).
The Draft Regulation has also now clarified that each submitted AHP application only has validity for one Drug item for a one-time import or export. Furthermore, the Draft Regulation also mandates that the applicable non-tax state revenue for AHP applications should be paid within seven calendar days of any such submission via BPOM’s website or SINSW.

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Indonesia’s Food and Drug Supervisory Agency (Badan Pengawas Obat dan Makanan – "BPOM") is currently preparing a Draft Regulation ("Draft Regulation") that will adjust various matters relating to the applicable requirements and procedures for the submission of applications for Analyses of Supervision Results (Analisa Hasil Pengawasan – "AHP") for Narcotics, Psychotropics and Pharmaceutical Precursors (collectively referred to as "Drugs"), as originally set out under Regulation of the BPOM No. 26 of 2020 ("Regulation 26/2020"). In this regard, inputs that specifically address the Draft Regulation may be submitted to BPOM by members of the general public until a deadline of 25 September 2023 through the following official link: http://bit.ly/FormatMasukanPERBPOM.
While the Draft Regulation still refers to the permitted purposes that underlie imports and exports of Drugs, the forthcoming framework has now removed the explicit obligation for AHP applicants for imports and exports of narcotics to be state-owned pharmaceutical wholesalers (Pedagang Besar Farmasi – "PBF"), as is currently the case under the framework of Regulation 26/2020. However, all narcotics importers and exporters must first secure special permits for these activities from the Minister of Health.
In addition to the currently applicable AHP application submission regime that is processed through BPOM’s official website for AHP services, the Draft Regulation now states that AHP applications may also be submitted through the Indonesian National Single Window System ("SINSW"). Moreover, the Draft Regulation classifies the various required documents for submissions of AHP applications as those that apply to pharmaceutical industries, those that apply to PBF (which specifically encompass eight types of documents) and those that apply to scientific institutions (which specifically encompass two types of documents).
The Draft Regulation has also now clarified that each submitted AHP application only has validity for one Drug item for a one-time import or export. Furthermore, the Draft Regulation also mandates that the applicable non-tax state revenue for AHP applications should be paid within seven calendar days of any such submission via BPOM’s website or SINSW.

......

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Precedent Hukumonline
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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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