Cosmetic Compliance
Intelligence & Solutions
Regulation concerning the Revocation of Regulation No. 26 of 2018 concerning Electronic Business Licensing Services Integration in Drug and Food Sector
Local Title:
Rancangan Peraturan Badan Pengawas Obat dan Makanan tentang Pencabutan Peraturan Kepala 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:
Draft
Release Date:
2024-01-04
Implementation Date:
/
Document
Language Source Title Access
ID
Official Regulation concerning the Revocation of Regulation No. 26 of 2018 concerning Electronic Business Licensing Services Integration in Drug and Food Sector
On-demand Translation Service
Regulation concerning the Revocation of Regulation No. 26 of 2018 concerning Electronic Business Licensing Services Integration in Drug and Food Sector
request
Summary

On January 4, 2024, the Indonesian Food and Drug Supervisory Agency (BPOM) issued a draft proposal to invalidate Regulation No. 26 of 2018, which pertains to the integration of electronic business licensing services in the drug and food sector. Regulation No. 26 of 2018, implemented on August 23, 2018, outlined the types of licenses required for the drug (including cosmetics) and food industries, along with corresponding requirements, application procedures, validity periods, and supervision measures. Specifically, it included provisions related to cosmetics licensing, such as the requirements for cosmetic notification certificates, GMP certificates, and import certificates.

BPOM's proposal to abolish Regulation No. 26 of 2018 stems from the release of Regulation No. 10 of 2021, which focuses on the Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Drug and Food Sector. This subsequent regulation offers more comprehensive and explicit guidelines regarding the requirements for obtaining cosmetics licenses. Consequently, the requirements specified in Regulation No. 26 of 2018 are no longer in line with current developments and must be invalidated.

Although the repeal requirement of Regulation No. 26 of 2018 has not yet taken effect, it is evident that BPOM intends to invalidate this regulation. For companies seeking licenses in the cosmetic industry, such as notification certificates, GMP certificates, or recommendation letters as a notification applicant, it is recommended to refer to the requirements outlined in Regulation No. 10 of 2021 to ensure compliance and obtain the necessary licenses.

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