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Term:
Refillable perfume: It is a perfume preparation made directly at the manufacturing facility by mixing fragrance concentrates with solvents in certain compositions according to consumer's demand;
Letter of recommendation as the notification applicant: Importers or business entities engaged in a production contract must obtain a recommendation as a notification applicant. This recommendation is secured by submitting a facilities inspection application to the Head of the local UPT BPOM;
Good manufacturing practice (GMP) certificate: It is a legal document serving as a proof that the cosmetic enterprise has fully implemented GMP in the manufacture of cosmetics;
Certificate of GMP fulfillment: It is a legal document serving as a proof that the cosmetic enterprise has gradually implemented GMP. The 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' compliance in 10 aspects in GMP, while Class B requires compliance in 2 aspects in GMP.
In September 2025, Indonesia released the Draft Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Food and Drug Subsector. 1 On October 3, 2025, Indonesia released and implemented the finalized version. 2 This Standards sets standards for licensing business activities related to drugs, food, and cosmetics.
Cosmetics-related licensing standards include:
1. Cosmetic Notification Standards
2. Standards for Cosmetic GMP Certificate
3. Standards for Class A GMP Fulfillment Certificate
4. Standards for Class B GMP Fulfillment Certificate
5. Standards for the Letter of Recommendation as the Notification Applicant
6. Standards for Approval of the Use of Natural Drug Production Facilities Together with Cosmetics and Processed Foods
7. Standards for Approval of the Use of Cosmetic Production Facilities Together with Household Health Supplies
8. Standards for Approval of the Use of Cosmetic Production Facilities Together with Quasi-Drugs
9. Standards for Pre-clinical Trial Approval for Cosmetics
10. Standards for Clinical Trial Approval for Cosmetics
The following summarizes key changes related to cosmetics notification and GMP applications.
1. Cosmetics Notification
1) Exemption: Refillable perfumes are explicitly exempt from notification requirements.
2) Processing Timelines. Specific processing timelines have been incorporated into the Standards:
New notification for non-fragrance products: max. 14 working days
New notification for fragrance products: max. 3 working days
Cosmetic kit notification: max. 3 working days
New notification for cosmetics specifically for export: max. 3 working days
Notification of changes/variations to companies/factories: max. 14 working days
Notification of changes/variations to packaging: max. 3 working days
Renewal for non-fragrance product notification: max. 14 working days
Renewal for fragrance product notification: max. 3 working days
Renewal for cosmetic kit: max. 3 working days
Renewal for cosmetics specifically for export notification: max. 3 working days
Application for letter of recommendation as the notification applicant: max. 12 working days
Amendments to applicant information: max. 5 working days
3) Time Limits:
Cosmetics must be produced, imported, and distributed within six months of notification.
Cosmetic notifications must be submitted within one year of obtaining the letter of recommendation as the notification applicant.
4) Document Requirements: Simplified by referencing the separate BPOM Regulation concerning the Procedure for Submitting Cosmetics Notification, rather than listing all requirements in the Standards.
2. GMP-related Certificates Application
1) Processing Timelines. Specific processing timelines have been incorporated into the Standards:
New applications: max. 35 working days
Approval of administrative changes: max. 10 working days
Approval of technical changes: max. 35 working days
Renewals: max. 35 working days
2) Document Requirements: Simplified by referencing the separate BPOM Regulation concerning the Technical Requirements for Cosmetic Good Manufacturing Practices Certification, rather than listing all requirements in the Standards.
3) Other Amendments
A GMP-related certificate is issued for each building based on the dosage form and/or the manufacturing processes conducted at all or certain stages. The updated provisions specify that:
GMP Certificate: When a series of manufacturing processes for a single dosage form is carried out across multiple buildings, a single GMP certificate will be issued.
Certificate of GMP Fulfillment: When a series of manufacturing processes is carried out across multiple buildings, one certificate may cover more than one dosage form, provided that the application for all dosage forms is submitted together.
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