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Kamis, November 23, 2023

BPOM Set to Issue New Procedure for Withdrawal and Destruction of Herbal Medicines, Quasi-Medicines and Health Supplements

Pharmacies, Health Industry, and Foods & Drugs Standard

Indonesia’s Food and Drug Supervisory Agency (Badan Pengawas Obat dan Makanan – "BPOM") is currently preparing the Draft Regulation on the Withdrawal and Destruction of Herbal Medicines, Quasi-Medicines and Health Supplements (collectively referred to as "Products") That Do Not Fulfill Safety, Benefit, Quality, Labeling and Advertising Standards ("Draft Regulation"). This new framework will simultaneously repeal and replace Regulation of the Head of the BPOM No. 5 of 2016 on the Withdrawal and Destruction of Herbal Medicines Which Do Not Fulfill Certain Standards ("Regulation 5/2016").
As its title suggests, the Draft Regulation covers a broader range of pharmaceutical products than Regulation 5/2016, which only addressed the withdrawal and destruction of herbal medicines. The Draft Regulation states that the scope of Products includes Products for which Distribution Licenses have already been secured, as well as Products that are imported into Indonesia through special access schemes.
Furthermore, the Draft Regulation has now divided up withdrawals into two schemes, specifically: mandatory withdrawals, which are performed based on official Withdrawal Instructions that are issued by the Head of BPOM; and voluntary withdrawals, which are initiated by Product license holders in cases where they have identified Product risks in relation to their distribution. For further background reading on the two new withdrawal schemes, see: Acts of Non-Compliance with Food Withdrawal Provisions to Result in PB-UMKU Revocation.

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Indonesia’s Food and Drug Supervisory Agency (Badan Pengawas Obat dan Makanan – "BPOM") is currently preparing the Draft Regulation on the Withdrawal and Destruction of Herbal Medicines, Quasi-Medicines and Health Supplements (collectively referred to as "Products") That Do Not Fulfill Safety, Benefit, Quality, Labeling and Advertising Standards ("Draft Regulation"). This new framework will simultaneously repeal and replace Regulation of the Head of the BPOM No. 5 of 2016 on the Withdrawal and Destruction of Herbal Medicines Which Do Not Fulfill Certain Standards ("Regulation 5/2016").
As its title suggests, the Draft Regulation covers a broader range of pharmaceutical products than Regulation 5/2016, which only addressed the withdrawal and destruction of herbal medicines. The Draft Regulation states that the scope of Products includes Products for which Distribution Licenses have already been secured, as well as Products that are imported into Indonesia through special access schemes.
Furthermore, the Draft Regulation has now divided up withdrawals into two schemes, specifically: mandatory withdrawals, which are performed based on official Withdrawal Instructions that are issued by the Head of BPOM; and voluntary withdrawals, which are initiated by Product license holders in cases where they have identified Product risks in relation to their distribution. For further background reading on the two new withdrawal schemes, see: Acts of Non-Compliance with Food Withdrawal Provisions to Result in PB-UMKU Revocation.

......

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Layanan Penerjemahan Peraturan
Precedent Hukumonline
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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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