BPOM Distribution Permit

BPOM Distribution Permit
(Izin Edar Badan Pengawas Obat dan Makanan)

Written by Dea Amanta Azaria on 05/08/2024
The author’s views are entirely their own and may not always reflect the views of Putranto Alliance.

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Introduction

The BPOM Distribution Permit issued by the Indonesian Food and Drug Supervisory Agency (Badan Pengawas Obat dan Makanan/BPOM) is critical for the distribution of processed food, medicine, or cosmetic products in Indonesia. This article explores its importance, the process, and how it ensures product safety and quality.

Definition

The BPOM Distribution Permit is a registration approval by BPOM that allows a product to be distributed in Indonesia.

Categories for the BPOM Distribution Permits are:

Processed food:
1. BPOM RI MD for processed food produced domestically.
2. BPOM RI ML for imported processed food.
Medicine: Distribution Permit.
Cosmetic: Approval known as Cosmetic Notification (Notifikasi Kosmetik/Notifkos).

Legal Basis:

The Importance/The Necessity

A BPOM distribution permit is essential for marketing products in Indonesia:

For local distributors, it enhances credibility and builds trust in the Indonesian market.
For import distributors, it ensures seamless market entry and establishes product reliability.

The detailed necessity for each product is as follows:

For Processed Food

Any individual that domestically produce or import processed food for trade in retail packaging is required to include a label that contains the BPOM Distribution Number (Nomor Izin Edar/NIE).

The retail packaging stated above must not be opened or repackaged into smaller packaging for trade.

The processed food label must contain:

Product name.
Ingredients.
Net weight.
Manufacturer/importer information.
Halal certificate (if required).
Production date and code.
Expiry information.
Distribution Number. and
Origin of the specific ingredients.

Types of products that are not required to obtain the BPOM Distribution Permit:

Processed food with a shelf life of less than 7 (seven) days.
Processed food used further as raw materials and not directly sold to end consumers.
Processed food packaged in bulk and not directly sold to end consumers.
Food, excluding food additives, which is sold and packaged directly in front of buyers in small quantities as per consumer requests.
Processed food manufactured by household food industries.
Processed food imported in small quantities for purposes such as sample testing and/or research.
Personal consumption.
Processed food for government program.
Processed food for donation.
Ready-to-eat food.
Food that undergoes only minimal processing (post-harvest), including washing, peeling, drying, grinding, cutting, salting, freezing, mixing, waxing, and/or blanching without altering its shape.

For Medicine:

Medicines intended for distribution in Indonesia must have a Distribution Permit (Izin Edar).

The pharmaceutical industry must create the registration submission to the BPOM system.

Medicines that obtain a Distribution Permit must meet the following criteria:

Proven efficacy and adequate safety that are demonstrated through non-clinical and clinical trials or other evidence in line with the current state of scientific knowledge.
Meets established standards, including production processes aligned with Good Manufacturing Practices (Cara Pembuatan Obat yang Baik/CPOB) and supported by valid evidence.
Product Information and Labeling must provide complete, objective, and non-misleading information to ensure medicines are used correctly, rationally, and safely.

For Cosmetics:

Business actors must ensure that cosmetics produced and/or imported for distribution in Indonesia meet the criteria of safety, efficacy, quality, labeling, and claims by obtaining a distribution permit, namely a “Notification”.

Types of cosmetics for registration consist of:

Domestically produced cosmetics:
1. Local cosmetics:
  Cosmetics produced and packaged by a cosmetic industry in Indonesia or produced abroad but packaged in primary packaging by a cosmetic industry in Indonesia.
2. Contract cosmetics:
  Cosmetics manufactured by a cosmetic industry abroad, in primary packaging at minimum.
Imported cosmetics:
Cosmetics that are manufactured by a cosmetic industry under a contract agreement.

Additionally, cosmetics used for research purposes and cosmetic samples for exhibitions in limited quantities are exempt from the notification requirements.

The Best Time to Obtain

The best time to get the permit is before launching processed food, medicine, or cosmetic products.

It is advisable to start the registration process at least 3–6 months in advance to avoid delays.

Medicine products require longer preparation, potentially up to a year, due to the extensive documentation and evaluation process.

Benefits of Using Professional Service

Professionals understand the complex requirements applications and can help streamline the process, minimizing non-compliance risk and subsequent penalties.
Businesses can save significant time managing requirements and dealing with regulatory agencies by relying on professionals to handle the process.

How to Obtain/The Process

For Processed Food

Company Account Registration:
Apply via the BPOM e-Registration system for the company details by submitting relevant data and profiles. The data and requirements vary based on the type of processed food:
1. Domestic.
2. Imported.
Product Data Registration and Risk Level Assessment: Register the product in the system by completing the processed food details and determining the product risk based on criteria such as ingredients, expiry date, production process, and target consumers. The data required varies based on the product risk level.
Issuance of Billing Statement and Payment: Submit proof of payment for the billing statement (Surat Perintah Bayar/SPB).
Validation:
The BPOM system verifies and validates processed food products based on their risk level. The validation timeline varies, with higher-risk products requiring additional evaluation steps.
Result From BPOM:
Upon verification, BPOM will either approve, reject, or wait for confirmation if the data needs to be revised. Successful products will receive the distribution permit number (Nomor Izin Edar/NIE) for the product.

For Medicine

Company Account Registration:
Apply via the BPOM e-Registration system for the company details by submitting relevant data and profiles. The data and requirements vary based on the type of processed food:
1. Domestic.
2. Imported.
Product Data Registration and Risk Level Assessment: Register the product in the system by completing the processed food details and determining the product risk based on criteria such as ingredients, expiry date, production process, and target consumers. The data required varies based on the product risk level.
Issuance of Billing Statement and Payment: Submit proof of payment for the billing statement (Surat Perintah Bayar/SPB).
Validation:
The BPOM system verifies and validates processed food products based on their risk level. The validation timeline varies, with higher-risk products requiring additional evaluation steps.
Result From BPOM:
Upon verification, BPOM will either approve, reject, or wait for confirmation if the data needs to be revised. Successful products will receive the distribution permit number (Nomor Izin Edar/NIE) for the product.

For Cosmetic

Company Account Registration:
Apply via the BPOM e-Registration system for the company details by submitting relevant data and profiles. The data and requirements vary based on the notification applicant:
1. Local cosmetic industry.
2. Individual businesses or contract-giving business entities. or
3. Cosmetic importer.
Product Data Registration:
Register the product in the system by completing the requirements data.
Issuance of Billing Statement and Payment:
Submit proof of payment for the billing statement (Surat Perintah Bayar/SPB).
Validation:
The BPOM system will verify and validate the requested cosmetic product. The duration varies based on the product risk level.
Result From BPOM:
Upon verification, BPOM will either approve or reject the application if the data needs to be revised. Successful products will receive the registration number (NIE) for the product.

How We Can Help

Our team provides comprehensive support to help businesses secure the BPOM Distribution Permit through:

Document Preparation and Submission:
We prepare all required documents and assist in submissions through OSS and BPOM systems.
Regulatory Guidance and Advisory:
We provide advice and tailored support to navigate complex regulatory requirements throughout the application process.
Trademark Registration Support:
We assist with registering trademarks to protect processed food, medicine, or cosmetic product identity and brand ownership.
Tax Advisory and Compliance:
We provide tailored tax services to ensure businesses remain financially compliant while optimizing tax benefits.

FAQs

Is there a need to renew the BPOM Distribution Permit?

Yes, it must be renewed every five years, at least ten days before expiration. During renewal processing, distribution can continue for up to six months. The Processed Food and Medicine Distribution Permit needs renewal every five years, while the Cosmetic Distribution Permit needs renewal every three years.

Is it necessary to have an NIB in OSS RBA?

Before registering for the BPOM Distribution Permit, ensure that the business actor has an NIB in the OSS RBA system. If the existing NIB was issued before the RBA system, an adjustment must be made through the OSS RBA application.

What are the types of BPOM Distribution Permit registration?

The types of registration include:

New Product Registration
Variation Registration
Re-Registration

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BPOM Distribution Permit (Izin Edar Badan Pengawas Obat dan Makanan)

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