Introduction

Pharmaceutical Wholesale Trade (Perdagangan Besar Farmasi or PBF) plays a crucial role in the distribution of pharmaceutical products in Indonesia. As a highly regulated sector, businesses involved in PBF must comply with strict legal requirements, licensing obligations, and operational guidelines established by the Indonesian government. This article provides an in-depth understanding of PBF, including licensing requirements, regulatory obligations, and key compliance aspects that businesses must adhere to.

What is Pharmaceutical Wholesale Trade (PBF)?

PBF refers to the business activity of distributing pharmaceutical products in bulk from manufacturers to pharmacies, hospitals, clinics, and other authorized entities. This distribution must be conducted through a legally registered pharmaceutical wholesaler that meets government standards to ensure the safety, efficacy, and quality of pharmaceutical products in the market.

Read More: Types of Products Requiring K3L

Key Requirements for Establishing a PBF Business in Indonesia

Setting up a PBF business in Indonesia requires compliance with the following legal and regulatory conditions:

1. Business Entity and Licensing
   • The business must be established as a Limited Liability Company (PT) in Indonesia.
   • Obtain a Pharmaceutical Wholesale Trade License (SIUPBF) issued by the Ministry of Health (Kementerian Kesehatan RI).
   • Secure additional permits, such as the Business Identification Number (NIB) through the Online Single Submission (OSS) system.

2. Qualified Pharmaceutical Personnel
   • The company must appoint a pharmacist-in-charge (Apoteker Penanggung Jawab or APJ) registered with the Ministry of Health.
   • Supporting pharmaceutical technical staff (Tenaga Teknis Kefarmasian) should be employed to ensure compliance with Good Distribution Practices (GDP).

3. Good Distribution Practices (GDP) Compliance
   • PBF businesses must adhere to Good Distribution Practices (CDOB) standards to ensure the safe handling, storage, and transportation of pharmaceutical products.
   • Maintain proper storage conditions, temperature control, and a tracking system for product distribution.
     
4. Facility and Storage Requirements
   • The facility must be designed in accordance with pharmaceutical storage regulations, including adequate temperature and humidity control.
   • The warehouse must comply with safety and security measures, ensuring that products are not exposed to contamination or unauthorized access.
5. Importation and Distribution Restrictions
   • PBF companies engaged in importing pharmaceutical products must obtain an Import License (API-P or API-U) and register their imported products with the National Agency of Drug and Food Control (BPOM).
   • Distribution is limited to registered and licensed pharmacies, hospitals, and medical institutions.

Regulatory Compliance and Ongoing Obligations

To maintain a valid SIUPBF and operate legally, businesses must:

1. Conduct regular audits to ensure compliance with CDOB.
2. Renew their pharmaceutical licenses periodically as required by the Ministry of Health.
3. Submit periodic reports on inventory and distribution activities to regulatory authorities.
4. Ensure that only registered pharmaceutical products with valid BPOM approvals are distributed.

Read More: Understanding K3L Certification for Products

Commonly Asked Questions about PBF

1. What is the validity period of the SIUPBF?
   • The SIUPBF is typically valid for five years and must be renewed before expiration.

2. Can a PBF distribute directly to consumers?
   • No, a PBF is only authorized to distribute pharmaceutical products to registered medical institutions, pharmacies, and other authorized entities.

3. What happens if a PBF does not comply with regulations?
   • Non-compliance may result in penalties, license revocation, or legal action by regulatory authorities.

4. How long does it take to obtain a SIUPBF?
   • The process may take several months, depending on document completeness and regulatory review timelines.

How ET Consultant Can Assist Your PBF Business

Navigating the legal and regulatory landscape of PBF in Indonesia can be complex. ET Consultant provides professional assistance Company registration and legal structuring for PBF businesses. Assist your company SIUPBF application and regulatory compliance advisory.

Contact ET Consultant today to ensure your Pharmaceutical Wholesale Trade (PBF) business operates legally and efficiently in Indonesia. Our team of legal and regulatory experts is ready to assist you with comprehensive solutions tailored to your business needs.

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ET Consultant is a Business Consultant and Legal Consultant Expert that provides support for local and multinational clients to start and manage their business operations in Indonesia. ET Consultant specializes in Business Incorporation, Licensing & Legal, Accounting & Taxes, Immigration, and Advisory Services.

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