Legal Insights

BPOM Registration of Foods and Medicine Products

Regulatory Framework for Food Registration

The requirements for food registration are stipulated under Law No. 18 of 2012 on Food (“Food Law”) which outlines the general principles for food safety, labeling, and marketing in Indonesia. As further implementation of the Food Law, the government has enacted Government Regulation No. 28 of 2021 as amended by Government Regulation No. 46 of 2023 on Industrial Sector Implementation which governs the implementation of food safety and quality regulations, including the requirements for food registration.

The specific requirements for food registration are outlined in the following regulations issued by the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan/BPOM):

(ii) BPOM Regulation No. 22 of 2018 on Guidelines for Granting Home Industry Food Production Certificates, which sets forth food safety and quality standards, including registration procedures, labeling requirements, and health claims for food
     products; and

(ii) BPOM Regulation No. 23 of 2018 on Home Industry Food Control Guidelines, which provides the framework for the registration of food supplements and functional foods.

In addition, food registration is subject to the Indonesian National Standards (SNI), particularly in relation to food safety and quality. These SNI standards are established by the National Standardization Agency (Badan Standardisasi Nasional/BSN) and are frequently referenced within BPOM regulations.

Regulatory Framework for Medicine Registration

The underlying requirements for medicine registration are stipulated under Law No. 17 of 2023 on Health (“Health Law”), which covers various aspects of public health, including the regulation and oversight of medicinal products. The Health Law has been implemented by the enactment of Government Regulation No. 28 of 2024 on the Implementing Regulation of Law No. 17 of 2023.

At the ministerial level, the government continues to implement Minister of Health Regulation No. 1010/MENKES/PER/XI/2008, as amended by Regulation No. 1120/MENKES/PER/XII/2008, which governs the procedures for medicine registration.

The specific requirements for medicine registration are further detailed in BPOM Regulation No. 24 of 2017, as amended by Regulation No. 27 of 2020 and No. 13 of 2021, on Criteria and Procedures for Medicine Registration, which provides comprehensive guidelines for the registration process.

General Registration Process

The process of food and medicine registration will generally involve the following steps: (i) document preparation and submission, (ii) BPOM evaluation, (iii) BPOM approval, and (iv) post-market surveillance.

In conducting its review or evaluation, BPOM will generally consider the following information:

1. Labeling requirements: Product labels must be compliant with the applicable BPOM regulations, including language, health claims, and ingredient disclosures.
2. Good manufacturing practice (GMP): BPOM enforces GMP standards to ensure that food and medicinal products are consistently produced and controlled according to quality standards. These standards are critical for maintaining product safety, quality, and efficacy. The BPOM GMP guidelines align with international practices but have specific requirements tailored to Indonesia's regulatory framework. Manufacturing facilities must therefore comply with the GMP standards, which are crucial for both food and medicine products.
3. Health claims: Any health claims displayed on the product package must be supported by scientific evidence and comply with the BPOM guidelines.

Challenges and Recommendations

The BPOM registration process in Indonesia can present several challenges, especially for foreign companies or those unfamiliar with the regulatory landscape. Here are some common challenges:

1. Understanding and navigating regulations
2. Extensive documentation
3. Language barriers
4. Compliance with Halal requirements
5. Laboratory testing and quality control:
6. Inspection and audits:
7. Time and costs
8. Post-market surveillance:
9. Handling regulatory updates:

In light of the aforementioned challenges, it is advisable for applicants to consider the following strategies:

1. Engage local regulatory consultants or experts who are well-versed in BPOM regulations and can provide guidance throughout the process.
2. Utilize certified translation services to ensure that all documents and labels are accurately translated and comply with BPOM standards.
3. Secure halal certification from a recognized authority prior to applying for BPOM registration, ensuring that all halal-related documentation is properly prepared.
4. Collaborate with accredited laboratories to ensure testing results meet BPOM requirements, with all reports being comprehensive and up-to-date.
5. Ensure that the manufacturing facility adheres to Good Manufacturing Practice (GMP) standards and is adequately prepared for inspections.
6. Conduct internal audits and address any potential issues prior to the official BPOM inspection.
7. Initiate the registration process early and allocate resources for potential costs and delays.
8. Implement a robust system for monitoring product performance, reporting any issues to BPOM, and fulfilling all post-market obligations.
9. Regularly check for updates on BPOM’s website and maintain communication with regulatory consultants to stay informed of any regulatory changes.

By addressing these challenges proactively and leveraging local expertise, companies can navigate the BPOM registration process more efficiently and ensure compliance with regulatory requirements.