Companies wishing to sell food, beverages, cosmetics or medicines in Indonesia must ensure that they abide by the local food safety regulations. In accordance with the Indonesian government regulations, all food, beverages, cosmetics and medicines distributed in Indonesia must be registered with the Food and Medicine Supervisory Board (Badan Pengawas Obat dan Makanan or BPOM). Selling and distributing products without a BPOM certification license (or izin BPOM)in Indonesia is subject to sanctions of up to two years of imprisonment and a fine of Rp1 billion. This article will provide a brief explanation of the BPOM registration process to sell your products legally in Indonesia.
The purpose of the BPOM Certification License
- Product control, regulations, and standardisation;
- Industrial licenses and certifications based on Good Manufacturing Practices;
- Product evaluation before allowing it to circulate;
- Post-marketing vigilance – This is the practice of monitoring the safety of the product after it has been released to the public through initiatives including sampling and laboratory testing, an inspection of production and distribution facilities, as well as investigation and law enforcement;
- Pre-audit and post-audit of product advertising and promotion;
- Research on the implementation of drug and food control policies;
- Information and public education, including public warnings.
Who Should Apply for A BPOM Certification License?
PMDN and PMA companies that sell and distribute processed food and beverage products, cosmetics, or medicines (including traditional and cosmetical drugs) in Indonesia must obtain a BPOM certification license. Note that the requirements for obtaining a BPOM certification differ depending on whether the product is manufactured locally or imported.
A foreign company that plans on importing their products but has not yet established a legal entity in Indonesia can either license their products to an Indonesian company or incorporate their Indonesian entity. If you opt for licensing, you need not apply for a BPOM certification license — the importing company will have to do it.
If you choose to pursue this course of action we strongly recommend that you have a good relationship with the importing company. In the event of conflicts that result in the termination of the partnership, the importing company may still be legally allowed to sell your products in Indonesia until their certification license expires. Consider contacting Permitindo to discuss your concerns and the appropriate structure for your business in more detail.
BPOM certification Procedures
Preparation Stage:
Prepare your legal documents and get your most updated certification requirements notarised and endorsed by the Indonesian Embassy in the product’s country of origin. Take notice that in some cases, the entire process of obtaining a distribution license from BPOM can take 12-18 months and therefore you have to ensure that your documents have at least a 12-month validity.
Spend a good amount of time researching whether your product complies with BPOM’s maximum limits of heavy metal pollution, microbial contamination, and permitted food additives used. This is paramount because if your product does not meet the criteria or if your product contains prohibited substances, you will not be able to move forward with the process. Most companies invest too little time in the preparation stage which leads to a much slower issuance of their licenses. The more prepared you are, the better your chances of speeding up the registration process.
Audit Stage:
The next stage is visiting the BPOM office in Jakarta and submitting an audit request for your storage facilities in Indonesia. You must bring a hard copy of your documents with you. BPOM authorities will conduct an audit once your request and the documents have been verified. This process can take up to a month.
Registration Stage:
Once the audit result of your storage facilities is issued, you can proceed with the company and product registration. Since the issuance of the Head of BPOM Regulation No: 26/2018 on Electronically Integrated Business Licensing Service in the Drugs and Food Sector, the registration of distribution license can be done online via e-BPOM.
Step 1: Registering your company
This is an easy and straightforward process. Fill in the form and upload all required and supporting documents on e-BPOM. They will verify your documents within days of submission and the result of the verification will be sent to your email.
Step 2: Registering your product
When your company registration information has been verified, you can register your product where you will provide your product’s technical data (e.g. Product Data, Raw Material Data, Analysis Result Data, Nutrition Value Data, etc). The process of registering your company and product usually takes 3-4 months for food and beverages, 6-8 months for cosmetics, and 8-12 months for medicines. The distribution license is valid for 5 years and can be extended by re-registration.
Step 3: Obtaining an Import Certificate (Surat Keterangan Impor)
In addition to a BPOM certification license, under the current import law, importers must obtain approval from BPOM in the form of an Import Certificate (SKI or Surat Keterangan Impor)[iii] which is valid for one product. The imported product must meet the following storage life requirements which dictate how much of the product’s storage life must still be available when the product is actually sold in Indonesia:
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For medicines, health supplements, and cosmetics: at least a third of the storage life (e.g. if a product has a total of 18 months storage life if it has less than 6 months of storage life left it cannot be sold in Indonesia);
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For biological products: at least 9 months before the expiry date;
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For processed food: at least two-thirds of the storage life.
You can apply for an Import Certificate (SKI) via e-BPOM only if your BPOM certification license has been issued. If your SKI registration is successful, BPOM will issue your SKI within 1-2 days.
Conclusion
Applying for a BPOM certification license can be a complex and lengthy process, requiring a thorough understanding of local laws and procedures. If you’re seeking guidance and support, Permitindo offers expertise and knowledge gained from years of experience in the field of BPOM certification license registration. We strive to assist you throughout the whole process, tailoring our services to meet your unique business needs.
Remember, Permitindo is an independent consultancy service and is not directly affiliated with BPOM or the Indonesian government. Our aim is to help you navigate regulatory procedures as effectively as possible.
Do you have further questions or need more detailed advice? We welcome the opportunity to hear from you. Feel free to get in touch via email at contact@permitindo.com, or fill out this form on our website. Your inquiries and feedback are essential to us.
Please note: Success in obtaining a BPOM certification license will depend on a number of factors including the nature of your product, compliance with local regulations, and the timeliness of the application process. Permitindo will help to streamline the process, but cannot guarantee the approval of your application.
References
[i] Government Regulation No 69, Year 1999
[ii] Head of BPOM Regulation No 26, Year 2018
[iii] Head of BPOM Regulation No 27, Year 2013
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