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Rabu, November 22, 2023

Scope of Food and Drug Products Subject to Mandatory SKI Border and Post-Border Now Adjusted

Pharmacies, Health Industry, and Foods & Drugs Standard

In an effort to ensure that the applicable mechanism for the importation of food and drug products ("Importation") is in line with current legal requirements, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") has decided to adjust the above-described Importation mechanism, as originally featured under the framework of Regulation of the BPOM No. 27 of 2022 ("Regulation 27/2022"), through the issuance of Regulation No. 28 of 2023 on the Amendment to Regulation 27/2022 ("Amendment"), which is set to come into force on 8 December 2023.
In essence, the Amendment has now adjusted 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 Letters (Surat Keterangan Impor – "SKI") Border: drugs, natural-ingredient drugs, quasi-drugs, health supplements and cosmetics; and 2) SKI Post-Border: processed foods. Previously, Regulation 27/2022 only included drugs and traditional medicines on the list of goods for which SKI Border were required to be secured for their importation.
The incorporation of natural-ingredient drugs, quasi-drugs, health supplements and cosmetics products under the SKI Border category means that said products will now be required to comply with various requirements that relate to the following areas: 1) Minimum storage periods; 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 Amendment now exempts government agencies that submit said applications under emergency conditions from this obligation. Instead, said agencies may utilize importer appointment letters that are issued by the relevant distribution permit holders as parties eligible to submit SKI Border applications.

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In an effort to ensure that the applicable mechanism for the importation of food and drug products ("Importation") is in line with current legal requirements, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") has decided to adjust the above-described Importation mechanism, as originally featured under the framework of Regulation of the BPOM No. 27 of 2022 ("Regulation 27/2022"), through the issuance of Regulation No. 28 of 2023 on the Amendment to Regulation 27/2022 ("Amendment"), which is set to come into force on 8 December 2023.
In essence, the Amendment has now adjusted 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 Letters (Surat Keterangan Impor – "SKI") Border: drugs, natural-ingredient drugs, quasi-drugs, health supplements and cosmetics; and 2) SKI Post-Border: processed foods. Previously, Regulation 27/2022 only included drugs and traditional medicines on the list of goods for which SKI Border were required to be secured for their importation.
The incorporation of natural-ingredient drugs, quasi-drugs, health supplements and cosmetics products under the SKI Border category means that said products will now be required to comply with various requirements that relate to the following areas: 1) Minimum storage periods; 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 Amendment now exempts government agencies that submit said applications under emergency conditions from this obligation. Instead, said agencies may utilize importer appointment letters that are issued by the relevant distribution permit holders as parties eligible to submit SKI Border applications.

......

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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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