What is a PKRT Notification Distribution Permit?
PKRT (Household Health Supplies) refers to devices, materials, or mixtures used for human health maintenance and care, intended for use in households and public facilities. These products are classified by risk level into three classes: Class 1 (low risk), Class 2 (medium risk), and Class 3 (high risk). Before marketing, products in Classes 1 and 2 must obtain a notification distribution permit. PKRT products in Classes 1 and 2 must have a notification distribution permit before they can be marketed. This requirement aligns with Ministry of Health Regulation No. 14 of 2021 on Standards for Business Activities and Products in Health Sector Risk-Based Licensing, which mandates that Class 1 and 2 PKRT products distributed in Indonesia must obtain a notification distribution permit.
A notification distribution permit is a simplified distribution license for Class 1 and 2 PKRT products. This process requires only notification to the relevant authorities, with applicants providing detailed product information without the need for clinical trials or in-depth evaluation, given these products’ lower to medium risk levels. In contrast, higher-risk Class 3 PKRT products not only require a full registration permit, but also involve a more complex process that includes additional verification measures to ensure product safety.
This article outlines the steps to obtain a new PKRT notification distribution permit for Class 1 and 2 products.
Objectives
- Control the distribution of PKRT products in Indonesia, including both domestic and imported products.
- Ensure consumer safety.
- Guarantee the effectiveness and benefits of PKRT products for consumers.
Requirements
The registration requirements for a new PKRT notification distribution permit include administrative and technical requirements, as outlined below:
| No | Requirement | Description |
|---|---|---|
| 1 | Administrative Data | – Production Certificate or NIB with KBLI that matches the registered product – Brand patent or brand ownership statement – Letter of Cooperation/relationship/license between the factory and the brand owner – Letter of authenticity of uploaded document/dataIntegrity pact letter – Letter of notification distribution permit |
| 2 | Formula Data | – Formula – Manufacturing procedure. |
| 3 | Product Compliance Document (DKP) | – Specification of raw materials and containers – Specifications and procedures for inspection of finished products – Finished product stability and expiration date – Intended use, instructions for use, warnings, cautions, other information – Production code – Marking / Labeling – Supporting data |
Steps to Register for a New Notification Distribution Permit
Applicants must complete the registration for a new PKRT notification distribution permit electronically via www.oss.go.id. Businesses can apply for the PKRT notification distribution permit through the PB-UMKU menu integrated with https://regalkes.kemkes.go.id. Applicants must complete all required PKRT notification registration documents in the regalkes system.
Registration Steps for a New PKRT Notification Distribution Permit:
- Fills out the application form, administrative data, formula data, and Product Compliance Document (DKP) as required.
- Determines the product’s risk class and receives a billing code for the payment of non-tax state revenue (PNBP).
- Pays the PNBP fee within 7 calendar days of receiving the billing code.
- The evaluation team reviews and verifies the application based on the risk class specified by the applicant:
- If the risk class is too low, the system adjusts the PNBP fee, and applicants must resubmit the application with a new billing code.
- If the risk class is too high, the process continues according to the correct risk class, but excess payment is non-refundable.
- If the risk class is accurate, the evaluation continues for safety, quality, and benefit requirements.
- When an application meets administrative and technical standards, the system issues the notification distribution permit. If it does not meet these standards, the system issues a rejection letter, and the applicant must reapply. Paid PNBP fees are non-refundable.
Service Time and Fees
The service time and fees for the notification distribution registration process are determined based on the PKRT product’s class. Service time is counted from when the registration documents are received for evaluation until the decision from the Director General is issued.
| Class | Processing Time | Fee* |
|---|---|---|
| 1 | 8 working days | Rp 1,000,000,- |
| 2 | 8 working days | Rp 2,000,000,- |
Sources:
Government Regulation (PP) Number 64 of 2019 on Types and Tariffs for Types of Non-Tax State Revenue Applicable at the Ministry of Health (https://peraturan.bpk.go.id/Details/120630/pp-no-64-tahun-2019)
Minister of Health Regulation Number 14 of 2021 on Standards for Business Activities and Products in Health Sector Risk-Based Licensing (https://farmalkes.kemkes.go.id/unduh/permenkes-14-2021/)
Pedoman Registrasi Izin Edar Notifikasi Perbekalan Kesehatan Rumah Tangga Kelas 1 dan 2 Tahun 2023
