The Healthtech industry in Indonesia has experienced rapid growth in recent years. Digital health platforms, e-Pharmacy services, electronic prescriptions, and application-based pharmaceutical distribution are increasingly adopted across the country.

Behind this expansion, businesses operating within the digital pharmaceutical ecosystem are required to comply with applicable regulations. One of the key regulatory obligations is the PSEF License (Pharmaceutical Electronic System Operator License).

Many companies consider the registration process challenging because the technical requirements are detailed and involve multiple functions including legal compliance, pharmacy operations, licensed pharmacists, business processes, and technology system integration.

This article provides a structured and practical guide on how to apply for the PSEF license issued by the Indonesian Ministry of Health, based on Minister of Health Regulation No. 26 of 2018 along with relevant updates in the health sector.

Through this guide, Healthtech operators and digital pharmacy businesses can better understand the licensing flow, required documentation, and technical aspects that must be prepared in advance.

What is PSEF and Why is the PSEF License Important?

According to Article 1 Number 81 of Minister of Health Regulation No. 26 of 2018,

PSEF is defined as a legal entity that provides, manages, or operates an e-Pharmacy system for its own operations or for third parties.

The scope of activities under PSEF includes:

  • Electronic prescription services 
  • Pharmacy services that utilize information technology
  • Online sale and distribution of pharmaceutical products

Article 3 Paragraph 1 Letter W stipulates that PSEF registration is classified as a health sector business license. Companies operating such services are required to obtain licensing approval from the Ministry of Health as regulated in Article 47 Paragraph 2 Letter Q.

In practice, the PSEF license functions as:

  • evidence of legal and regulatory compliance
  • a formal safeguard for consumer and patient protection
  • an official collaboration mechanism between business operators, pharmacies, and licensed pharmacists

The validity period of the PSEF license follows the validity of the Electronic System Provider Registration in accordance with prevailing regulations. In the pharmaceutical sector, licenses are generally reviewed under a five-year evaluation cycle and may be extended subject to continued compliance.

Initial Requirements: KBLI Classification and Legal Entity Registration via OSS

At the preliminary stage, e-Pharmacy and Healthtech operators must ensure that the business is registered as a legal entity. The PSEF license cannot be submitted by an individual entity and must instead be registered as:

  • a Limited Liability Company (PT)
  • a Foundation
  • a Cooperative

The company must hold a Business Identification Number (NIB) registered through the OSS. 

Referring to Permenkes No. 17 of 2024, relevant KBLI (Indonesian Standard Industrial Classification) examples include:

  • 47721: Retail Trade of Pharmaceuticals for Human Use in Pharmacies
  • 46442: Wholesale Trade of Traditional Medicines and Natural Based Pharmaceutical Products

In addition to the NIB, companies may also be required to hold IUI (Industrial Business License) or PMSE (Electronic Commerce License) depending on the business model and operational structure.

OSS Registration for PSEF, Kominfo Integration Prior to Ministry of Health Submission

Before applying for the PSEF license, the company must first obtain the Domestic Electronic System Provider Registration via OSS RBA.

Process overview:

  1. Log in to the company OSS RBA account
  2. Select PB UMKU, Business Support Licensing 
  3. Submit a new application according to the relevant KBLI
  4. Complete the PSE Submission Form provided by Kominfo/Komdigi
  5. Continue to the PDP, Personal Data Protection assessment
  6. Save the submission and wait for email confirmation
  7. Print the license document via OSS RBA

The PSE registration document will automatically synchronize with pse.kominfo.go.id and becomes a mandatory prerequisite before continuing to the PSEF submission process with the Ministry of Health.

How to Apply for the PSEF License at the Ministry of Health

Once OSS and PSE registration requirements are completed, companies may submit their PSEF application through psef.kemkes.go.id with the following steps:

  1. Register a company account
  2. Upload required supporting documents
    • company profile data
    • pharmacist in charge
  3. Upload all required supporting documents
  4. Submit business process documentation and service commitment files
  5. Submit API (Application Programming Interface) documentation and system integration readiness
  6. Undergo administrative and technical evaluation

The validity of the license follows the validity period of the PSE Registration and is reviewed periodically in accordance with pharmaceutical regulatory standards.

Complete Document Checklist for the PSEF License

Based on the Ministry of Health’s official reference, required documents include:

Administrative Documents

  • NIB and OSS documentation link
  • IUI or PMSE business license
  • Company application letter
  • Pharmacist in Charge data:
    • National Identity Card 
    • STRA, Pharmacist Registration Certificate
    • SIPA, Pharmacy Practice License at a partner pharmacy
  • supporting documents for pharmacy and IT professionals
  • statement letter of document authenticity

Operational and Business Process Documents

  • Business Process Documentation (Dokumen Proses Bisnis)
  • Prescription service workflow
  • Transaction documentation
  • Pharmacist verification procedures
  • Delivery and return procedures

Partner Pharmacy Network Data

The required partner pharmacy data includes:

  • Pharmacy name
  • Pharmacy license number
  • Full address and GPS coordinates
  • Pharmacist name at partner pharmacy
  • Pharmacist practice schedule

Application System and Public Information Display

The platform must clearly display product information including:

  • Product name and Marketing Authorization Number (NIE)
  • Product classification and dosage form
  • Original product images
  • Expiry date
  • Price and stock availability status

In addition, the system must be capable of:

  • ensuring prescriptions are dispensed in accordance with regulatory rules
  • storing and enabling traceability of prescription records
  • providing real time patient communication features
  • enabling pharmacists to validate or reject prescriptions when required by regulation

PSEF API Requirements and Technical IT Considerations

This component differentiates the PSEF license from general digital business licensing because it includes data interoperability requirements.

What is PSEF API Documentation?

API documentation serves as a technical reference used to:

  • explain API functionality
  • define the scope of API use
  • support standardized system integration

In practice, API documentation functions as the technical manual for the e-Pharmacy system architecture.

System Interoperability Obligation

The e-Pharmacy system must ensure that transaction data can be accessed automatically by the Ministry of Health on a 24-hour basis as part of regulatory monitoring and service evaluation.

This requirement strengthens transparency and accountability in digital pharmaceutical services.

Data Security and Personal Data Protection

Assessment areas include:

  • Implementation of PDP, Personal Data Protection controls
  • Server and access security
  • Traceability of historical records
  • Confidentiality assurance of user data

XPND Support in the Preparation and Management of the PSEF License

The preparation of the PSEF license often requires more than document completion alone. Companies must ensure readiness across areas such as:

  • alignment of legal entity structure and KBLI classification
  • preparation of business process documentation for e-Pharmacy operations
  • API documentation and technical compliance readiness
  • consistency between OSS records and operational implementation

In practice, many organizations choose to seek assistance to help interpret regulatory requirements and reduce the risk of repeated revisions during submission.

XPND supports organizations in preparing their PSEF license submission by assisting in:

  • aligning legal entity structure and KBLI classification with business activities
  • harmonizing company and licensing data within OSS
  • preparing e-Pharmacy business process documentation
  • preparing API documentation and relevant technical materials
  • ensuring readiness of interoperability and data security requirements

This support helps organizations ensure alignment across administrative, operational, and technical documentation so that their e-Pharmacy systems meet Ministry of Health evaluation standards.

For businesses that have not yet established a legal entity, XPND also provides assistance in:

  • Incorporation of a PT, Limited Liability Company
  • Selection of appropriate KBLI classifications
  • Legal structuring to support future PSEF license submission

This assistance helps organizations enter the PSEF evaluation stage with stronger preparation and a clearer implementation pathway.