[{"_1":2,"_123":-5,"_124":-5},"loaderData",{"_3":4,"_28":29,"_30":31},"root",{"_5":6,"_7":-5,"_8":9},"locale","id","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","f8021e2b-dec0-486f-877f-00488037cfb2","regulationData",{"_36":33,"_37":38,"_119":120,"_121":122},"regulation_id","overview",{"_39":40,"_41":42,"_43":44,"_45":46,"_47":48,"_49":50,"_51":52,"_53":54,"_59":60,"_61":62,"_66":67,"_71":72,"_73":74,"_75":76,"_77":78,"_79":-5,"_80":81,"_82":83,"_84":-5,"_85":86,"_87":88,"_89":88,"_90":91,"_98":99,"_100":101,"_102":103,"_104":105,"_106":107,"_108":109,"_110":111,"_112":113,"_114":115,"_116":-5,"_117":118},"title","Peraturan Menteri Kesehatan Nomor 4 Tahun 2023 tentang Penyelenggaraan Fraksionasi Plasma","short_title","Peraturan Menteri Kesehatan Nomor 4 Tahun 2023","number","4","year","2023","published_date","2023-01-06","effective_date","2023-01-17","status_id","3611a577-44a0-41ad-986d-7457e14f52ff","status",{"_6":52,"_55":56,"_57":58},"name","Berlaku","description","Peraturan yang masih berlaku dan memiliki kekuatan hukum yang mengikat","type_id","f56450e8-0878-4624-b859-3ca52b69d8e6","type",{"_6":60,"_55":63,"_64":65},"Peraturan Menteri Kesehatan","short_name","Permenkes","subjects",[68],{"_6":69,"_55":70,"_57":-5},"10e70ff8-158d-4e9e-849e-554938c706d9","Pelayanan Kesehatan","tags",[],"location","Kementerian Kesehatan","place_of_enactment","Jakarta","theme","Penyelenggaraan Fraksionasi Plasma","subject_matter","abstract","\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n


2023
Peraturan Menteri Kesehatan NO. 4, BN.2023/No.73, peraturan.go.id: 11 hlm.
Peraturan Menteri Kesehatan TENTANG Penyelenggaraan Fraksionasi Plasma
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Menteri Kesehatan ini mulai berlaku pada tanggal 17 Januari 2023. \n \n

","regulatory_relationship","Peraturan ini mencabut: 1. Peraturan Menteri Kesehatan Nomor 15 Tahun 2019 tentang Penyelenggaraan Fraksionasi Plasma (Berita Negara Republik Indonesia Tahun 2019 Nomor 781)","scope_and_parties","policy_content","

Latar Belakang dan Tujuan: Peraturan ini dibuat untuk melindungi masyarakat terhadap mutu, keamanan, dan kemanfaatan produk obat derivat plasma. Peraturan ini menggantikan Peraturan Menteri Kesehatan Nomor 15 Tahun 2019 yang sudah tidak sesuai dengan perkembangan hukum dan kebutuhan masyarakat.

Ketentuan Substansial: Peraturan ini mengatur penyelenggaraan fraksionasi plasma yang harus dilakukan di fasilitas fraksionasi plasma yang memiliki izin produksi dari Menteri. Industri farmasi yang terlibat harus memenuhi persyaratan tertentu, termasuk memiliki sertifikat CPOB. Peraturan ini juga mengatur tentang penyelenggaraan fraksionasi plasma secara kontrak dengan industri luar negeri, impor dan ekspor produk obat derivat plasma, serta distribusi produk tersebut. Selain itu, peraturan ini menetapkan kewajiban pencatatan dan pelaporan oleh fasilitas fraksionasi plasma kepada Kementerian Kesehatan.

","transitional_provisions","(-)","sanctions","revokes",[92],{"_93":94,"_95":96,"_36":97},"text","Permenkes No. 15 Tahun 2019 tentang Penyelenggaraan Fraksionasi Plasma","link","https://peraturan.bpk.go.id/Details/138609/permenkes-no-15-tahun-2019","34ba897a-4056-41a7-a8b0-c3e67efbb5b0","revoked_by",[],"partially_revokes",[],"partially_revoked_by",[],"amends",[],"amended_by",[],"partially_amends",[],"partially_amended_by",[],"establishes",[],"established_by",[],"constitutional_review","is_verified",false,"english_excerpt","\n

STATE GAZETTE
REPUBLIC OF INDONESIA
No.73, 2023 MINISTRY OF HEALTH. Implementation of Fractionation
Plasma. Revocation.

REGULATION OF THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA
NUMBER 4 OF 2023
on
IMPLEMENTATION OF PLASMA FRACTIONATION

WITH THE BLESSINGS OF GOD ALMIGHTY

THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA,

Considering / Whereas:

that the implementation of plasma fractionation is carried out to protect the public against the quality, safety, and benefits of plasma derivative drug products;
that Regulation of the Minister of Health Number 15 of 2019 on the Implementation of Plasma Fractionation is no longer in accordance with legal developments and the needs of the community in implementing the fulfillment of plasma derivative drug products for health services, so it needs to be replaced;
that based on the considerations as referred to in letters a and b, and to implement the provisions of Article 25

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