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Rabu, April 17, 2024

BPOM Plans to Amend Provisions on Manufacture of Medicines Within Hospitals

Pharmacies, Health Industry, and Foods & Drugs Standard

The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") is currently preparing a Draft Regulation ("Draft Regulation") that will amend Regulation of BPOM No. 12 of 2022 on Guidelines for the Proper Manufacture of Medicines Within Hospitals.
In essence, the Draft Regulation introduces the new term, "Radiopharmaceutical" (radiofarma). This term is defined as chemical compounds that contain radioisotopes and that are capable of meeting various pharmacological requirements for use in diagnostics, therapy and clinical medical research into nuclear medicine.
The Draft Regulation also states that the production of medicines (including radiopharmaceuticals) will be exempted in terms of the synthesis of medicines in accordance with prescriptions or doctors’ instructions.

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The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") is currently preparing a Draft Regulation ("Draft Regulation") that will amend Regulation of BPOM No. 12 of 2022 on Guidelines for the Proper Manufacture of Medicines Within Hospitals.
In essence, the Draft Regulation introduces the new term, "Radiopharmaceutical" (radiofarma). This term is defined as chemical compounds that contain radioisotopes and that are capable of meeting various pharmacological requirements for use in diagnostics, therapy and clinical medical research into nuclear medicine.
The Draft Regulation also states that the production of medicines (including radiopharmaceuticals) will be exempted in terms of the synthesis of medicines in accordance with prescriptions or doctors’ instructions.

......

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Rp 7.500.000

per bulan

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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