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Regulation No.5 of 2024 concerning the Revocation of Regulation No. 26 of 2018 concerning Electronic Business Licensing Services Integration in Drug and Food Sector
Local Title:
Peraturan Badan Pengawas Obat dan Makanan Nomor 5 Tahun 2024 tentang Pencabutan Peraturan Badan Pengawas Obat dan Makanan Nomor 26 Tahun 2018 tentang Pelayanan Perizinan Berusaha Terintegrasi Secara Elektronik Sektor Obat Dan Makanan
Country/Region:
Indonesia
Competent Authority:
Badan Pengawas Obat dan Makanan
Type:
Regulation
Status:
In force
Release Date:
2024-04-05
Implementation Date:
2024-04-05
Document
Language Source Title Access
ID
Official BPOM Regulation No.5 of 2024 concerning the Revocation of Regulation No. 26 of 2018 concerning Electronic Business Licensing Services Integration in Drug and Food Sector
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Summary

On January 4, 2024, the Indonesian Food and Drug Supervisory Agency (BPOM) issued a draft proposal to invalidate Regulation No.26 of 2018. This regulation pertains to the integration of electronic business licensing services in the drug and food sector. On April 5, 2024, BPOM officially invalidated Regulation No.26 of 2018 by issuing and implementing Regulation No. 5 of 2024 concerning the Revocation of BPOM Regulation No. 26 of 2018.

Regulation No.26 of 2018 was implemented on August 23, 2018, and it outlined the types of licenses required for the drug (including cosmetics) and food industries. The regulation also provided information on corresponding requirements, application procedures, validity periods, and supervision measures. It specifically included provisions related to cosmetics licensing, such as the requirements for cosmetic notification certificates, GMP certificates, and import certificates.

The decision to abolish Regulation No.26 of 2018 stems from the release of Regulation No.10 of 2021. This subsequent regulation focuses on the Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Drug and Food Sector. Regulation No. 10 of 2021 offers more comprehensive and explicit guidelines regarding the requirements for obtaining cosmetics licenses. As a result, the requirements specified in Regulation No. 26 of 2018 are no longer aligned with current developments and need to be invalidated.

The repeal of Regulation No. 26 of 2018 is now in effect. Companies seeking licenses in the cosmetic industry, such as notification certificates, GMP certificates, or recommendation letters as a notification applicant, should refer to the requirements outlined in Regulation No. 10 of 2021 to ensure compliance and obtain the necessary licenses.

History
2024-04-05
Regulation No.5 of 2024 concerning the Revocation of Regulation No. 26 of 2018 concerning Electronic Business Licensing Services Integration in Drug and Food Sector
In force
Release Date: 2024-04-05
Implementation Date : 2024-04-05
2024-01-04
2020-08-04
2020-05-04
2018-08-23
Invalid
Release Date: 2018-08-23
Implementation Date : 2018-08-23
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