Aright Tech - Thoughts Archive

Entering the Indonesian market can be a rewarding opportunity for international businesses. However, to ensure the safety and quality of products, the National Agency of Drug and Food Control of Indonesia, known as Badan Pengawas Obat dan Makanan (BPOM), has a stringent registration system in place. This article provides a detailed understanding of BPOM's legal regulations, product categories, warehouse requirements, and the role of the Indonesian Technical In-Charge (PJT).

I. BPOM Legal Regulations

BPOM is an official Indonesian government agency responsible for regulating food, drugs, cosmetics, and medical devices. All products intended for sale in the Indonesian market must comply with BPOM's legal regulations. These laws encompass aspects such as product safety, efficacy, quality, and labeling.

II. Product Categories

BPOM primarily supervises four main product categories:

1. Food: Includes pre-packaged food, additives, special dietary foods, etc.
2. Drugs: Includes prescription drugs, non-prescription drugs, traditional medicines, etc.
3. Cosmetics: Includes facial skincare products, makeup, perfumes, etc.
4. Medical Devices: Includes medical equipment, diagnostic devices, therapeutic devices, etc.

Each category has its own specific requirements and procedures for registration.

III. BPOM Registration Process and Requirements

The registration process with BPOM involves the following steps:

1. Product Information Submission: Initially, detailed information about the product, including its ingredients, manufacturing process, storage conditions, etc., needs to be provided.

2. Product Sample Evaluation: Once the product information is submitted, a product sample needs to be evaluated by BPOM for safety, efficacy, and quality.

3. Approval Process: BPOM approves the product based on the product information and evaluation results. Approval timelines may vary depending on the product category and complexity.

4. Issuance of Registration Certificate: After approval, a BPOM registration certificate is issued, proving the product's compliance with BPOM regulations and eligibility for sale in the Indonesian market.

IV. BPOM Warehouse Requirements

BPOM mandates that all products intended for sale in Indonesia must be stored in warehouses complying with BPOM standards. These warehouses must meet the following requirements:

1. Warehouse Condition: The warehouse must maintain good sanitary conditions to ensure the product is not contaminated.

2. Product Management: Strict management rules for product storage, inflow, and outflow must be in place to ensure product quality and safety.

3. Product Traceability: A system to trace products must be in place to quickly identify related products if a problem arises.

V. Role of the Indonesian Technical In-Charge (PJT)

Indonesian regulations dictate that each company registered with BPOM should have a PJT. The PJT is a licensed pharmaceutical professional in Indonesia, responsible for overseeing the quality and safety of the company's products. The main responsibilities of a PJT include:

1. Product Quality Assurance: Ensuring that the company's products meet BPOM's quality requirements.

2. Product Safety Oversight: Overseeing the safety of the company's products to prevent safety issues.

3. Regulatory Compliance: Ensuring the company adheres to all BPOM regulations.

Navigating the BPOM registration process can be complex and involves meeting several requirements, including warehouse standards and PJT requirements. Therefore, we offer professional BPOM registration services to help you understand the BPOM system, meet all registration requirements, and facilitate your product's smooth entry into the Indonesian market. Our services include providing product registration consultation, assisting with the registration process, offering warehouse solutions, and helping secure a qualified PJT. Allow us to be your reliable assistant in entering the Indonesian market