Cosmetics Product Regulatory Affairs Services in Indonesia
Your trusted regulatory strategic partner for Cosmetic services in Indonesia. We help streamline cosmetics product registration in Indonesia by working closely with BPOM. From dossier preparation to regulatory submission, we guide you through each stage.
Regulatory Guidance for Cosmetics Registration in Indonesia
Regulatory affairs and compliance services for cosmetic products in Indonesia, including BPOM notification, product approvals, and labeling review.
Indonesia’s cosmetic market is competitive and one of the largest market for skincare product with different regional requirement. Our regulatory expert has decades of experience and offers effective strategies to expediate product launch and seamless management of cosmetic in Indonesia. Artixio’s regulatory team provides comprehensive regulatory services throughout cosmetic product lifecycle.
Key Regulations for Cosmetic Products in Indonesia
In Indonesia, cosmetic products are regulated by the BPOM (BADAN POM, Badan Pengawas Obat dan Makanan), National health authority of Indonesia responsible for ensuring cosmetic product is compliance with standards and regulations.
- Cosmetic products must be in compliance with the ASEAN Cosmetic Directive (ACD).
- (BPOM) Regulation No. 14 of 2017- Guidance on Product Information File (PLF)
- BPOM Regulation No. 18 of 2024- Outlines on labeling and advertisement of cosmetics.
- Notifkos 3.0 system- New cosmetic notification system
Steps for Cosmetic Notification Submission
Administrative Requirements
- For local company- Cosmetic Product Manufacturer License
- Foreign Manufacturer (importer)- Local authorized agent with importer identification number.
Document Preparation
- Trade Business License
- Certificate of Good Manufacturing Process (GMP)
- Certificate of Free Sale (CFS)- for foreign manufacturer
- Intended Use/Claims
- Label requirement
- Product Information File (PIF)
Notifkos Account Generation
- Notifkos is an e-Service portal for submission of cosmetic product notification. Authorized person must create account through Notifkos system prior submission of cosmetic product notification.
- Account registration itself takes 2-3 months time.
Submission of Cosmetic Product Notification
- Submit product notification online with proper documents submission.
- After successful notification submission, notification number will be issued.
Fee payment
Professional Regulatory Consulting Services in Indonesia
Artixio’s Services for Cosmetic Products in Indonesia
- Local representative services
- Local language translator
- Support for account generation on online portal
- Gap assessment and consultant
- Product compliance review as per ACD
- Classifying cosmetic product as per ACD regulations
- Strategic regulatory support throughout product lifecycle
- Labeling support
Why Choose Artixio for Indonesia BPOM Cosmetics Product Registration Support?
FAQs
What is BPOM Regulation No. 18 of 2024 (PerBPOM 18/2024) updates?
- BPOM enacted the new regulatory development of cosmetics on November 15, 2024. BPOM Regulation No. 18 of 2024 address following provisions
- Halal Labeling Requirements
- Inclusion of 2D barcodes on cosmetic labeling
- Routine inspections & Incidental inspections
- Strict regulations on refillable cosmetics
What is the validity of import license certificate of cosmetic?
What are the fees required to be paid for Cosmetic product notification?
| Sr. No. | Purpose | Fees |
|---|---|---|
| 1. | Non-ASEAN products (Foreign Manufacturer) | IDR 1,500,000 |
| 2. | ASEAN-made products | IDR 500,000 |
What is Product Information File (PIF) for cosmetic product in Indonesia?
- Product Information File (PIF) is a document containing detailed information of cosmetic products from development to post-market surveillance. PIF includes following information
- Administrative Information
- Product Safety Assessment
- Product Specifications
- Stability Data
- Manufacturing Process
- Labeling
- Adverse Event Reporting
- PIF should be maintained for 10 years from the date of the last batch placed in market, must be made available as requested by health authority BPOM.
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