How to Apply for a PKRT Liquid Detergent Distribution Permit

Law of the Republic of Indonesia Number 36 of 2009 concerning Health and Regulation of the Minister of Health No. 62 of 2017 concerning Distribution Permits for Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies state that Household Health Supplies (PKRT) circulating in Indonesia must have a distribution permit.

Photo by Anna Shvets

Detergent is a material or preparation that is one of the PKRT products of risk class II, which contains soap and/or surfactants used for washing and cleaning. This product is available in various forms such as liquid, powder, and paste, and is used for household, institutional, or industrial purposes. Liquid detergent is a liquid cleaner designed for washing clothes and kitchen utensils, using safe materials that do not cause skin irritation.

 

1. Administrative Requirements

The required documents include:

• Production Certificate
  Required for locally manufactured products.

• Letter of Appointment (LoA)
  
  • • A letter from the principal/origin factory appointing a single agent/distributor, legalized by the Indonesian Embassy (KBRI) in the origin country.
  • • Must specify the trade name, product type, and have a validity period of at least two years.

• Certificate of Free Sales (CFS)
  A document issued by the relevant authority in the origin country certifying that the product is distributed in that country.

• ISO 9001 or Good Manufacturing Practice (GMP) Certificate
  
  • • Covers the production of liquid detergents.
  • • Issued by a certification body for ISO 9001 or a competent authority for GMP.

• Statement Letter for Brand Patent or Agency Release
  A letter declaring the brand patent rights or the release of agency rights.

For more details, access here: Pedoman Bimbingan Teknis PKRT (kemkes.go.id)

 

2. Technical Requirements

a. Formulation and Manufacturing Procedures

Typical composition of liquid detergent products:

• Active ingredients: Sodium Alkyl Benzene Sulfonate, Methyl Ester Sulphonate, etc.

• Additives: Sodium Hydroxide, Smectite Clay, etc.

• Solvents: Demineralized water, 1,2-propanediol.

• Colorants: CI 42051, CI 74160.

• Fragrance: Lemon, floral perfumes.

• Preservatives: 1,2-benzisothiazolin-3-one.

Manufacturing Procedure:

1. Mixing: Combine main and additional ingredients until homogeneous.
2. Filling: Transfer the mixture into safe containers for storage and transportation.

 

b. Specifications for Raw Materials and Containers

• • Test results for raw materials from suppliers or factory QC.

• • Container specifications, including shape, material, and size.

 

c. Finished Product Specifications and Stability

QC test results for the finished product, covering:

• • Data from the finished product tests issued by the factory’s QC, including the type of tests conducted, parameters, specifications/standards, test results, and signed by the responsible party, which includes:

• • a. Physical parameters: shape, odor, color, viscosity

• • b. Below is the Table of Quality Requirements for Liquid Laundry Detergent for Clothes.

 

---

 

Labeling Requirements for Liquid Laundry Detergents

The product label for liquid laundry detergents must include at least the following:
a. Distribution Permit Number
b. Trade Name/Brand of the Household Health Supplies (PKRT)
c. Name and Address of the Manufacturer/Factory Producing the PKRT
d. Name and Address of the Importer Bringing the Product into Indonesia
e. Production Code/Batch Number/Serial Number
f. Intended Use in Indonesian
g. Warnings/Precautions in Indonesian
h. Instructions for Use in Indonesian
i. Expiration Date
j. Name and Percentage of Active Ingredients
k. Net Weight, stated in metric units

 

 

---

 

Steps for Registering a New PKRT Distribution Permit

1. Application Submission
   Fill out the application form and complete the administrative and technical requirements.
2. Risk Class & Payment
   Determine the product’s risk class and pay the PNBP fee within 7 days.
3. Evaluation by Review Team
4. Review Draft Permit
5. Review and provide feedback on the draft within 24 hours. Correct errors if needed.
6. Document Deficiency Notification
   Complete any missing documents within 10 days.
7. Re-Evaluation
   Review team re-evaluates after document completion within 10 days.
8. Rejection Letter
   If requirements aren’t met, a rejection letter is issued, and a new application is required.
9. Permit Issuance
   If all requirements are met, the distribution permit is issued

1.  

---

 

PNBP Registration Fees

The registration fee for a PKRT distribution permit for Risk Class II is IDR 2,000,000, based on Government Regulation No. 64 of 2019.

 

---

 

Permit Issuance

Following the evaluation of safety, quality, and efficacy, the distribution permit is issued by the Minister of Health through the Directorate General of Pharmaceuticals and Medical Devices.

In accordance with Regulation of the Minister of Health No. 1190/Menkes/Per/VIII/2010, the distribution permit number must be displayed on the product with the following format:

• Domestic Products: KEMENKES RI PKD XXXXXXXXXX

• Imported Products: KEMENKES RI PKL XXXXXXXXXX

Photo by 卜 兰 from Pexels

Sources:
Guidelines for the Assessment of Medical Devices and Household Health Supplies – Ministry of Health