Certification Through the OSS System
Article 3 requires GMP certificates and GMP aspect fulfillment certificates to be issued through the Online Single Submission (OSS) system. The OSS platform is electronically connected to BPOM’s official e-certification system.
Under Regulation No. 33 of 2021, companies submitted applications through BPOM’s dedicated e-certification portal. Regulation No. 8 of 2026 shifts the process to the OSS platform.
Two Types of Compliance Certificates
Article 2 states that cosmetic manufacturers must implement GMP and demonstrate compliance through either a GMP Certificate or a GMP Aspect Fulfillment Certificate.
A GMP Certificate is a legal document confirming that a cosmetic company has fully implemented GMP requirements. Applicants must submit a GMP certificate application letter using the format in Annex I, documents covering the implementation of 12 quality management system aspects listed in Annex II, and appoint a technical responsible person. GMP certificates are issued according to dosage form and remain valid for five years.
The GMP Aspect Fulfillment Certificate is a legal document showing that a cosmetic company has progressively implemented GMP requirements.
Class A, described as Progressive, applies to companies capable of producing all cosmetic dosage forms. It 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 for this class may only be requested once.
Class B applies to companies using simple technology to manufacture specific dosage forms. It requires compliance with two aspects, sanitation and hygiene, and documentation. Applicants must also submit a building floor plan. GMP aspect fulfillment certificates can cover more than one dosage form.
What Has Changed for Manufacturers?
BPOM Regulation No. 8 of 2026 introduces several procedural changes that manufacturers should be aware of.
The regulation establishes clear timelines for the certification process and clarifies renewal requirements. GMP certificates remain valid for five years, and manufacturers must apply for renewal at least six months before expiration. Whether a facility inspection is required during renewal will depend on previous inspection and supervision results.
Changes to certified facilities are now clearly categorized as administrative or technical. Administrative updates, such as changes to a company name or address, do not require inspection. Certain technical modifications, including changes affecting cleanliness classifications or the addition of off-site warehouses, will trigger a facility inspection.
Manufacturers planning to share production facilities with quasi-drugs or household health products must obtain prior BPOM approval and submit supporting documentation, including GMP certification, cleaning validation records, equipment capacity information, and production schedules.
The regulation also outlines the consequences of non-compliance. Companies that fail to meet GMP requirements, operate outside their approved scope, or do not renew certificates on time may face sanctions ranging from written warnings to suspension of production activities or revocation of their certificates.
For companies already holding approvals under the previous framework will remain valid until their expiration dates. BPOM has also stated that no fees will apply to GMP aspect fulfillment certificates and shared facility approvals for quasi-drugs until specific fee regulations are introduced.
