New Registration of PKL (Import Household Disinfectant Distribution License) / PKD (Local Household Disinfectant Distribution License)

According to the 2023 Indonesian Ministry of Health guidelines for the issuance and registration of licenses for Class 1 and Class 2 Household Health Supplies (PKRT), PKRT refers to tools, materials, or mixtures of materials used for maintenance and care in households and public places. Based on these regulations, every PKRT distributor must have a PKL/PKD license.

Basic Informations

1. According to the 2023 Indonesian Ministry of Health guidelines for the issuance and registration of licenses for Class 1 and Class 2 Household Health Supplies (PKRT), PKRT refers to tools, materials, or mixtures of materials used for maintenance and care in households and public places. Based on these regulations, every PKRT distributor must have a PKL/PKD license.

2. Household and public disinfectants (PKRT) are tools, materials, or mixtures of materials used in homes and public places to maintain and care for human health, intended to kill bacteria or insects.

3. According to the risk during use, they are classified into two risk levels:

· Level 1 – Low risk (Tissues and Cotton Products: Cotton pads, facial tissue/toilet paper, oil blotting papers, wet wipes, cotton swabs, and other tissue and cotton-based products.)

· Level 2 – Medium risk (Detergents, cleansers, baby and maternal care products, antibacterials and disinfectants, fragrances)

4. For obtaining a local PKRT license, the company must have the following KBLI codes:

· 23121

· 20231

· 17091

· 22194

· 22299

· 21015

For obtaining an import PKRT license, the company must have the following KBLI code:

· 46499

5. The PKL/PKD license is valid for 5 years and must be renewed at least 3 months before the expiration date to avoid system deactivation and suspension of sales authorization.

6. Possession of a PKL/PKD license is mandatory for household and public disinfectant products (PKRT). Without a PKL/PKD license, the product will be considered illegal and may be subject to mandatory recall by the Ministry of Health. The PKRT license aims to regulate these products to ensure their safety, quality, and efficacy, whether locally manufactured or imported.

7. Household and public disinfectant products (PKRT) must possess a PKL/PKD license. Without this license, the product will be considered illegal and may be subject to mandatory recall by the Ministry of Health.

Processing Time & Required Documents

Processing Time : 15 Working Days

Required Documents :

General Documents:
1.      Company Documents
2.      Company Information
3.      OSS Account
4.      Director’s Personal Information

Technical Documents:
1.      Application Form for Registration License
2.      Distribution License Declaration Letter (PKRT Notification License)
3.      Hague-Apostilled Letter of Authorization (LOA)
4.      Certificate of Free Sale (CFS with Hague Apostille + Sworn Translation)*
5.      ISO 9001 Certification of the Factory*
6.      Certificate of Good Manufacturing Practices for Household Health Supplies (CPPKRTB)
7.      Trademark Registration Certificate (may be registered abroad)
8.      Trademark Ownership Declaration
9.      Letter of Agent Release
10.   Declaration of Document Authenticity
11.   Integrity Pact

Product Documents:
1.      Product Formulation
2.      Production Flow Chart
3.      Factory Information

Product Conformity Documents:
1.      Specifications of Raw Materials and Packaging Containers
2.      Certificates of Analysis (CoA) for Raw Materials and Finished Products
3.      Finished Product Specifications and Testing Procedures
4.      Stability Data and Shelf Life of the Finished Product
5.      Intended Use, Instructions, Warnings, Precautions, and Other Information (IFU)
6.      Production Batch Number
7.      Label/Markings
8.      Packaging Specifications
9.      Supporting Data Consistent with the Declarations