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4.2. How to Register Household Health Supplies (PKRT)
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Basic Information

1. Household Health Supplies (PKRT) are tools, ingredients or mixtures of ingredients used for the maintenance and preservation of human health and hygiene by households and public places.

2. According to Indonesian Law, Regulation No. 36 of 2009 on the Ministry of Health and Hygiene and Regulation No. 14 of 2021 on the Commercial Activities and Product Standards in the Implementation of Risk-Based Business Licenses in the Health Sector, Household Health Supplies (PKRT) distributed in Indonesia must have a distribution permit issued by the Ministry of Health.

3. Household Health Supplies Distribution Permit means that the product has met the standards of safety, quality and profitability, which is issued by local manufacturers and/or importers who intend to sell in Indonesia.

4. The following are some of the product categories and the products of Household Health Supplies.

5. The validity period of the Household Health Supplies Distribution Permit is 5 years, or according to the validity period on the Letter of Agreement (LoA), which is at least 2 years and up to 5 years.

Flow Process and Processing Time

1. Processing Time: 30 Working Days;

*) The completion time above, starts after all required data is complete;

2. Flow Process:

  • Step 1: Collecting Required Documents and Product Sample;
  • Step 2: Conduct Product Testing (10-15 Working Days);
  • Step 3: Drafting and Applying for Household Health Supplies Distribution Permit (5 Working Days);
  • Step 4: Receiving Payment Order (SPB) and pay PNBP fee;
  • Step 5: Document verification by Ministry of Health (10 Working Days);
  • Step 6: Submission of additional data based on Ministry of Health feedback (if any);
  • Step 7: Issuance of Household Health Supplies Distribution Permit Number (NIE PKRT) (2 Working Days);

Document Required

1. Company Document

🏢 Company Legal Documents

  • Deed of Establishment + Approval from the Ministry of Law and Human Rights
  • Business Identification Number (NIB)
  • Company Tax ID (NPWP)
  • Appropriate KBLI (for PKRT distribution/trading activities)

📍 Domicile & Facilities

  • Domicile Certificate / Business Address
  • Office and/or warehouse layout
  • Proof of ownership or lease agreement

👤 Technical Person in Charge (PJT)

  • ID Card (KTP)
  • Educational certificate (minimum Diploma/Bachelor, preferably relevant field)
  • Appointment letter as Technical Person in Charge
  • CV / work experience

🏭 Quality System & Operations

  • SOP for goods receiving
  • SOP for storage
  • SOP for distribution
  • SOP for complaint handling & product recall

Organizational Structure

📦 Warehouse & Storage

  • Warehouse photos
  • List of facilities (racks, pallets, AC, etc.)
  • Storage system (including product segregation if required)

2. Product Document

đź“„ Product Legal Documents

  • PKRT Marketing Authorization Number
  • Letter of Authorization (LoA) from the principal (for imported/distributed products)
  • Certificate of Free Sale (CFS) (for imported products)

🏭 Manufacturer Documents

  • Quality system certificates (ISO / GMP if available)
  • Manufacturing license from country of origin
  • Manufacturer company profile

đź“‘ Technical Documents

  • Product specifications
  • Composition/ingredients (for chemical-based products such as disinfectants)
  • Manufacturing process (summary)
  • Product brochure / catalog

🏷️ Labeling & Packaging

Label design (must be in Bahasa Indonesia)

Required information:

  • Product name
  • Intended use
  • Directions for use
  • Composition
  • Marketing authorization number
  • Name & address of manufacturer/importer

🔬 Testing & Safety (if required)

  • Laboratory test reports
  • MSDS (Material Safety Data Sheet) for chemical products
  • Stability test (if required)
  • Efficacy claims (e.g., for disinfectants)

Document Obtain After Completion

1. Household Health Supplies Distribution Permit Number (NIE PKRT);

2. Payment Order (SPB);

*Note:

  • 1. This service does not include Document Translation Fee.
  • 2. Registering Household Health Supplies Distribution Permit does not include PNBP fees.
  • 3. Below is list of KBLI PKRT:
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