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Kamis, Oktober 19, 2023

Issued EUA for COVID-19 Drugs and Vaccines Now Applicable as Limited Distribution Licenses

Pharmacies, Health Industry, and Foods & Drugs Standard

The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") has issued Regulation No. 26 of 2023 on Monitoring of the Use of COVID-19 Drugs and Vaccines Post-Termination of COVID-19 Pandemic Mitigation in Indonesia, which has been in force since 13 October 2023.
The Regulation states that any Emergency Use Authorizations ("EUA") for COVID-19 drugs and vaccines that were previously issued during the COVID-19 pandemic are now effectively applicable as limited distribution licenses. Accordingly, holders of said licenses are obliged to ensure and guarantee that any COVID-19 drugs and vaccines in their possession meet various requirements relating to safety, benefits and quality.
Said limited distribution licenses have automatic applicability without the need for the submission of any further applications by EUA holders and will be applicable for a period of two years commencing from the termination date of the COVID-19 pandemic status. However, the following applicable limitations must be complied with: 1) No further COVID-19 drugs and vaccines may be imported into Indonesia; 2) No further variations are permitted in relation to issued EUA approvals; and 3) COVID-19 drugs and vaccines may not be distributed to any healthcare facilities other than those that have been appointed to handle patients in line with public health emergency criteria.
If any COVID-19 drugs and vaccines are still having their EUA processed, then said submissions should be shifted to submissions for the securing of distribution licenses from the BPOM in compliance with applicable requirements and criteria.

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The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") has issued Regulation No. 26 of 2023 on Monitoring of the Use of COVID-19 Drugs and Vaccines Post-Termination of COVID-19 Pandemic Mitigation in Indonesia, which has been in force since 13 October 2023.
The Regulation states that any Emergency Use Authorizations ("EUA") for COVID-19 drugs and vaccines that were previously issued during the COVID-19 pandemic are now effectively applicable as limited distribution licenses. Accordingly, holders of said licenses are obliged to ensure and guarantee that any COVID-19 drugs and vaccines in their possession meet various requirements relating to safety, benefits and quality.
Said limited distribution licenses have automatic applicability without the need for the submission of any further applications by EUA holders and will be applicable for a period of two years commencing from the termination date of the COVID-19 pandemic status. However, the following applicable limitations must be complied with: 1) No further COVID-19 drugs and vaccines may be imported into Indonesia; 2) No further variations are permitted in relation to issued EUA approvals; and 3) COVID-19 drugs and vaccines may not be distributed to any healthcare facilities other than those that have been appointed to handle patients in line with public health emergency criteria.
If any COVID-19 drugs and vaccines are still having their EUA processed, then said submissions should be shifted to submissions for the securing of distribution licenses from the BPOM in compliance with applicable requirements and criteria.

......

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Precedent Hukumonline
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PROFESSIONAL

Rp 4.500.000

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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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