[{"_1":2,"_125":-5,"_126":-5},"loaderData",{"_3":4,"_28":29,"_30":31},"root",{"_5":6,"_7":-5,"_8":9},"locale","en","session","ENV",{"_10":11,"_12":13,"_14":15,"_16":17,"_18":19,"_20":21,"_22":23,"_24":25,"_26":27},"APP_ENV","production","APP_URL","https://veritask.ai","GA_MEASUREMENT_ID","G-X1BV3QBZEM","META_PIXEL_ID","4698743733686194","TIKTOK_PIXEL_IDS","D8A3HTBC77U9J3L243V0","CLARITY_PROJECT_ID","wn9rn7xb4l","AMPLITUDE_API_KEY","74a0c7cc1509a379d3647ec140dd375","MIDTRANS_CLIENT_KEY","Mid-client-hwjEU5pmwAKVMbIA","MIDTRANS_SNAP_URL","https://app.midtrans.com/snap/snap.js","routes/$locale",{"_5":6},"routes/$locale.search-engine.regulation.$regulationId",{"_32":33,"_34":35},"regulationId","e61051ce-bf04-4fab-8714-ea7a1a8d6215","regulationData",{"_36":33,"_37":38,"_121":122,"_123":124},"regulation_id","overview",{"_39":40,"_41":42,"_43":44,"_45":46,"_47":48,"_49":50,"_51":52,"_53":54,"_60":61,"_62":63,"_67":68,"_72":73,"_74":75,"_76":77,"_78":79,"_80":-5,"_81":82,"_83":84,"_85":-5,"_86":87,"_88":89,"_90":91,"_92":93,"_94":95,"_96":97,"_98":99,"_100":101,"_102":103,"_110":111,"_112":113,"_114":115,"_116":117,"_118":-5,"_119":120},"title","Peraturan Badan Pengawas Obat dan Makanan Nomor 30 Tahun 2022 tentang Pemasukan Obat dan Bahan Obat\r\nmelalui Mekanisme Jalur Khusus (Special Access\r\nScheme)","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 30 Tahun 2022","number","30","year","2022","published_date","2022-11-24","effective_date","2022-12-02","status_id","3611a577-44a0-41ad-986d-7457e14f52ff","status",{"_55":52,"_56":57,"_58":59},"id","name","Berlaku","description","Peraturan yang masih berlaku dan memiliki kekuatan hukum yang mengikat","type_id","6f5779f5-e2ea-448d-8bb0-b22517233239","type",{"_55":61,"_56":64,"_65":66},"Peraturan Badan Pengawas Obat dan Makanan","short_name","Peraturan BPOM","subjects",[69],{"_55":70,"_56":71,"_58":-5},"10e70ff8-158d-4e9e-849e-554938c706d9","Pelayanan Kesehatan","tags",[],"location","Badan Pengawas Obat dan Makanan","place_of_enactment","Jakarta","theme","Pemasukan Obat dan Bahan Obat\r\nmelalui Mekanisme Jalur Khusus (Special Access\r\nScheme)","subject_matter","abstract","\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n

Pemasukan - Obat - Bahan Obat - Mekanisme Jalur Khusus - Special Access Scheme
2022
Peraturan Badan Pengawas Obat dan Makanan NO. 30, BN 2022 (1185)
Peraturan Badan Pengawas Obat dan Makanan TENTANG Pemasukan Obat dan Bahan Obat\r\nmelalui Mekanisme Jalur Khusus (Special Access\r\nScheme)
ABSTRAK:	\n \n bahwa untuk melindungi masyarakat dari pemasukan\r\nobat dan bahan obat ke dalam wilayah Indonesia yang\r\ntidak memenuhi standar dan/atau persyaratan\r\nkeamanan, khasiat, dan mutu, perlu mengatur mengenai\r\npemasukan obat dan bahan obat melalui mekanisme\r\njalur khusus (special access scheme) \n Dasar hukum peraturan ini adalah Perpres Nomor 80 Tahun 2017; Peraturan BPOM Nomor 21 Tahun 2020 sebagaimana telah\r\ndiubah dengan Peraturan BPOM Nomor 13 Tahun 2022; Peraturan BPOM Nomor 26 Tahun 2022; Peraturan BPOM Nomor 27 Tahun 2022; Peraturan BPOM Nomor 30 Tahun 2022 \n Peraturan ini mengatur mengenai kriteria dan persyaratan; tata cara permohonan; pengawasan dan syarat administratif pemasukan obat dan bahan obat melalui SAS \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 02 Desember 2022. \n 21 hlm; hlm 1 sd 19 batang tubuh, hlm 20 sd 21 lampiran \n \n

","regulatory_relationship","Peraturan ini mengubah:\n1. Peraturan Badan Pengawas Obat dan Makanan Nomor 26 Tahun 2022 tentang Pengawasan Pemasukan Bahan Obat dan Makanan ke dalam Wilayah Indonesia.\n2. Peraturan Badan Pengawas Obat dan Makanan Nomor 27 Tahun 2022 tentang Pengawasan Pemasukan Obat dan Makanan ke dalam Wilayah Indonesia.","scope_and_parties","policy_content","

Peraturan ini bertujuan untuk melindungi masyarakat dari pemasukan obat dan bahan obat yang tidak memenuhi standar keamanan, khasiat, dan mutu. Badan Pengawas Obat dan Makanan (BPOM) memiliki fungsi pengawasan sebelum dan selama peredaran obat. Peraturan ini menetapkan mekanisme jalur khusus (Special Access Scheme/SAS) untuk pemasukan obat dan bahan obat yang sangat dibutuhkan namun belum memiliki izin edar. Pemasukan ini harus mendapat persetujuan dari Kepala BPOM atau Menteri Kesehatan, tergantung jenis obatnya. Obat dan bahan obat yang dimasukkan harus memenuhi kriteria tertentu, seperti berasal dari sumber resmi, tidak untuk keperluan komersial, dan dalam jumlah terbatas. Peraturan ini juga mengatur persyaratan khusus untuk SAS produk biologi, obat penelitian, dan bahan obat, termasuk dokumen yang harus disertakan dalam permohonan SAS.

","transitional_provisions","(-)","sanctions","

1. Pelanggaran terhadap ketentuan dalam Pasal 2, Pasal 5 ayat (1), Pasal 6, Pasal 10 ayat (1), Pasal 11 ayat (1), Pasal 15 ayat (1), Pasal 16 ayat (1), Pasal 16 ayat (7), Pasal 18 ayat (2), Pasal 24 ayat (1), dan/atau Pasal 25 dikenai sanksi administratif berupa peringatan, peringatan keras, penghentian sementara kegiatan, perintah penarikan dan/atau pemusnahan obat dan bahan obat, dan/atau pencabutan perizinan berusaha.

","revokes",[],"revoked_by",[],"partially_revokes",[],"partially_revoked_by",[],"amends",[],"amended_by",[104],{"_105":106,"_107":108,"_36":109},"text","Perka BPOM No. 12 Tahun 2024 tentang Perubahan atas Peraturan Badan Pengawas Obat dan Makanan Nomor 30 Tahun 2022 tentang Pemasukan Obat dan Bahan Obat melalui Mekanisme Jalur Khusus (Special Access Scheme)","link","https://peraturan.bpk.go.id/Details/297137/peraturan-bpom-no-12-tahun-2024","4f532fcf-a0e1-4e49-bf72-2fca462e0359","partially_amends",[],"partially_amended_by",[],"establishes",[],"established_by",[],"constitutional_review","is_verified",false,"english_excerpt","\n

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 30 OF 2022
CONCERNING
ENTRY OF DRUGS AND DRUG SUBSTANCES THROUGH THE MECHANISM OF
SPECIAL ACCESS SCHEME

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG CONTROL AGENCY,

Considering:

that to protect the public from the entry of drugs and drug substances into the territory of Indonesia that do not meet the standards and/or requirements of safety, efficacy, and quality, it is necessary to regulate the entry of drugs and drug substances through a special lane mechanism (special access scheme);
that based on the provisions of Article 3 paragraph (1) letter d of Presidential Regulation Number 80 of 2017 concerning the Food and Drug Control Agency, the Food and Drug Control Agency has the function of carrying out pre-market supervision and post-market supervision;
that based on the considerations as referred to in letters a and b, and to implement the provisions of

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