Terms:
GMP certificate is a legal document serving as proof that the cosmetic enterprise has fully implemented GMP in the manufacture of cosmetics;
GMP aspect fulfillment certificate is a legal document serving as proof that the cosmetic enterprise has gradually implemented GMP. The fulfillment certificate is divided into Class A and Class B. Class A is applicable to enterprises that can produce all types of cosmetics, while Class B is applicable to enterprises that can only produce certain types of cosmetics. Class A requires enterprises to comply with requirements for 10 aspects in GMP, while the Class B requires enterprises to comply with requirements for 2 aspects in GMP.
On April 29, 2026, Indonesia's Food and Drug Supervisory Agency (BPOM) promulgated Regulation No. 8 of 2026 concerning the Technical Requirements for Cosmetic GMP Certification, which replaces the previous Regulation No. 33 of 2021. 1
While the regulation is effective immediately upon promulgation, previously issued GMP certificates, GMP aspect fulfillment certificates, and shared facility approvals under Regulation No. 33 of 2021 remain valid until their respective expiration dates.
Key Amendments
1. Integration with the OSS System
The new regulation mandates that the issuance of both the GMP certificate and the GMP aspect fulfillment certificate must be processed through the Online Single Submission (OSS) system, which is electronically integrated with the BPOM system.
Aspect | Regulation No. 33 of 2021 (Previous) | Regulation No. 8 of 2026 (New) |
|---|---|---|
Application Platform | BPOM's official e-certification portal | Online Single Submission (OSS) system integrated with BPOM's official e-certification portal |
2. Changes to Required Documents and the Verification Period for Applications
The new regulation introduces the following changes to the required documents and the verification timeline for GMP certification applications:
1) Removal of Certain Documentation Requirements
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