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Selasa, Oktober 17, 2023

Mandatory SKI Border and Post-Border Approvals for Imports of Food and Drug Products Set to Be Adjusted

Pharmacies, Health Industry, and Foods & Drugs Standard

The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan - "BPOM") is currently preparing the Draft Regulation ("Draft Regulation") on the Amendment to Regulation of BPOM No. 27 of 2022 ("Regulation 27/2022") on the Supervision of Imports of Food and Drugs into Indonesian Territory.
If ultimately enforced, the Draft Regulation will adjust the scope of the various food and drug products for which import approvals must be secured from the Head of BPOM. Said approvals and products break down as follows: 1) Import Notification Letter (Surat Keterangan Impor – "SKI") Border: drugs, natural-ingredient drugs, quasi-drugs, health supplements and cosmetics; and 2) SKI Post-Border: processed foods.
It should be noted that the inclusion of the abovementioned natural-ingredient drugs along with quasi-drugs, health supplements and/or cosmetics means that said products will be required to comply with various requirements that relate to the following areas: 1) Minimum storage period; 2) Issuance of alternative analysis certification; 3) Additional requirements for the securing of SKI Border; and 4) Imports for certain purposes.
Submissions of SKI Post-Border applications for imports of processed food products must be accompanied by scans of original processed food management system certificates. However, the Draft Regulation exempts government agencies that submit said applications under emergency conditions from this obligation. Instead, said parties may utilize importer appointment letters from the relevant distribution permit holders as those eligible to submit SKI Border application.
The BPOM is currently soliciting input regarding the Draft Regulation until a deadline of 17 October 2023. Said input may be submitted via: https://bit.ly/Masukan-PB27_2022.

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The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan - "BPOM") is currently preparing the Draft Regulation ("Draft Regulation") on the Amendment to Regulation of BPOM No. 27 of 2022 ("Regulation 27/2022") on the Supervision of Imports of Food and Drugs into Indonesian Territory.
If ultimately enforced, the Draft Regulation will adjust the scope of the various food and drug products for which import approvals must be secured from the Head of BPOM. Said approvals and products break down as follows: 1) Import Notification Letter (Surat Keterangan Impor – "SKI") Border: drugs, natural-ingredient drugs, quasi-drugs, health supplements and cosmetics; and 2) SKI Post-Border: processed foods.
It should be noted that the inclusion of the abovementioned natural-ingredient drugs along with quasi-drugs, health supplements and/or cosmetics means that said products will be required to comply with various requirements that relate to the following areas: 1) Minimum storage period; 2) Issuance of alternative analysis certification; 3) Additional requirements for the securing of SKI Border; and 4) Imports for certain purposes.
Submissions of SKI Post-Border applications for imports of processed food products must be accompanied by scans of original processed food management system certificates. However, the Draft Regulation exempts government agencies that submit said applications under emergency conditions from this obligation. Instead, said parties may utilize importer appointment letters from the relevant distribution permit holders as those eligible to submit SKI Border application.
The BPOM is currently soliciting input regarding the Draft Regulation until a deadline of 17 October 2023. Said input may be submitted via: https://bit.ly/Masukan-PB27_2022.

......

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Precedent Hukumonline
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PROFESSIONAL

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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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