On April 29, 2026, Indonesia's Food and Drug Supervisory Agency (BPOM) promulgated Regulation No. 8 of 2026 on Cosmetic Good Manufacturing Practice (GMP) Certification, replacing the previous Regulation No. 33 of 2021. The regulation takes effect upon promulgation. Notably, GMP certificates, GMP aspect fulfillment certificates, and shared facility approvals issued under Regulation No. 33 of 2021 remain valid until their respective expiration dates.
Integration with the OSS System
The new regulation mandates that both GMP certificates and GMP aspect fulfillment certificates must be issued through the Online Single Submission (OSS) system, which is electronically integrated with BPOM's official e-certification system (Article 3).
Under the previous Regulation No. 33 of 2021, applications were submitted through BPOM's dedicated e-certification portal. The new regulation consolidates the process onto the unified OSS platform.
GMP Certificate and GMP Aspect Fulfillment Certificate
Under Article 2, cosmetic manufacturers must implement GMP and demonstrate compliance through one of the following two instruments:
GMP Certificate: A legal document certifying that the cosmetic enterprise has fully implemented all GMP requirements. Applicants must submit a GMP certificate application letter (Annex I format), implementation documents for 12 aspects of the quality management system (Annex II), and designate a technical responsible person. GMP certificates are issued per dosage form and are valid for 5 years.
GMP Aspect Fulfillment Certificate: A legal document certifying that the cosmetic enterprise has progressively implemented GMP. It is divided into two classes:
- Class A (Progressive): Applicable to enterprises capable of producing all types of cosmetic dosage forms. Requires compliance with 10 GMP quality management aspects (quality management system, personnel, buildings and facilities, equipment, sanitation and hygiene, production, quality control, documentation, storage, complaint handling and product recall). Renewal of this class of certificate may only be requested once.
- Class B: Applicable to enterprises using simple technology to produce specific dosage forms. Requires compliance with 2 aspects (sanitation and hygiene, documentation) and submission of a building floor plan. GMP aspect fulfillment certificates may cover more than one dosage form.
Application Process and Timelines
The new regulation specifies clear timelines for each stage of the certification process:
(1) Document verification: Within 7 working days from the upload of application documents, BPOM shall complete the verification of document completeness (Article 7(5), Article 11(8)).
(2) Payment: Upon successful document verification, the enterprise receives an electronic payment order and must complete payment within 7 working days (Article 7(8), Article 11(11)).
(3) Facility inspection coordination: BPOM shall coordinate with the manufacturer to conduct facility inspections within 20 working days from receipt of payment (Article 8(1), Article 12(1)).
(4) Certificate issuance: Using a "clock on/clock off" mechanism, certificates shall be issued within 35 working days from the date of facility inspection (Article 8(3), Article 12(3)).
(5) Additional data: If additional data is required during evaluation, enterprises may submit additional data up to 3 times, each within 20 working days from the date of the evaluation notification (Article 8(6), Article 12(6)). The evaluation clock is paused during the additional data submission period.
Certificate Renewal and Amendment
(1) Renewal: Certificates are valid for 5 years (Article 16). Certified enterprises that continue to manufacture cosmetics must apply for renewal at least 6 months before the certificate expires (Article 18(2)). Whether a facility inspection is required for renewal depends on the most recent supervision and inspection results — if unresolved findings or potential issues exist regarding product safety, quality, or GMP compliance, a facility inspection is required; otherwise, no inspection is needed (Article 19).
(2) Amendment: Amendments are classified as administrative changes (company name, address, etc.) and technical changes (production capacity expansion, warehouse additions/removals, room function changes, etc.). Administrative changes do not require facility inspection. Technical changes involving changes to cleanliness levels or addition of off-site warehouses require facility inspection (Article 20).
Shared Production Facilities
Chapter III of the new regulation (Articles 30-41) governs the use of shared production facilities between cosmetic manufacturers and quasi-drugs (Obat Kuasi) and/or household health products (PKRT). Prior approval from BPOM is required. Applications must submit documents including a valid GMP certificate, equipment capacity data, cleaning validation protocols and records, raw material composition and specifications, and production scheduling plans. The approval letter for shared facility use follows the same validity period as the GMP certificate.
Penalties
Enterprises that violate GMP implementation obligations, produce beyond their approved scope, or fail to renew certificates as required will be subject to the following administrative sanctions (Article 42): written warnings, temporary suspension of production activities (up to 1 year), temporary closure of electronic access for cosmetic notification applications, temporary closure of electronic access for GMP certificate applications, temporary closure of electronic access for GMP aspect fulfillment certificate applications, and revocation of GMP certificates or GMP aspect fulfillment certificates.
Transitional Provisions
Article 44 provides that GMP certificates, GMP implementation confirmation letters, GMP aspect fulfillment certificates, and shared facility approval letters issued prior to the effective date of this regulation remain valid until their respective expiration dates. Meanwhile, until fee regulations for GMP aspect fulfillment certificates and shared facility approvals for quasi-drugs are established, no fees shall be charged for such certificates and approvals (Article 45).
CIRS Reminder
Indonesia BPOM's update to cosmetic GMP certification requirements integrates the certification process into the OSS system, specifies detailed timelines for applications and a supplementary data mechanism, clarifies renewal conditions, and incorporates shared facility management for quasi-drugs and household health products into the regulatory framework. It is recommended that relevant cosmetic enterprises promptly benchmark against the new requirements and plan certificate renewals and applications accordingly to ensure continuity of compliant production.
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