START NOW – For food or drug manufacturers in Indonesia, it is important for you to understand how to apply for BPOM license. 

Furthermore, you need to practice this knowledge on how to apply for BPOM license. That way, your business will be able to operate safely. 

What is BPOM and its Responsibilities?

BPOM is a government agency in Indonesia whose role is to monitor and regulate health products circulating in the market. 

The name BPOM stands for Badan Pengawas Obat dan Makanan (Food and Drug Administration). It is responsible for overseeing the safety of consumer products.

BPOM must to ensure that food, drug, and cosmetic products on the market have meet the quality and safety standards.

To succeed in its role as a regulatory body, BPOM is responsible for the following matters: 

Safety Supervision

Ensuring that products are safe and won’t endanger the safety of consumers or users is the main task of BPOM.

This includes testing products to ensure they do not contain hazardous materials or contaminants that could endanger consumer health.

Licensing

BPOM has an authority to grant distribution permits for certain products after going through a rigorous evaluation and testing process. 

This license indicates that the product has met the applicable legal and technical requirements that guarantee its quality and safety. 

How to apply for BPOM license? This procedure requires a number of steps and requirements which we will discuss further later.

Inspection and Testing

BPOM is also authorized and required to conduct administrative and technical checks on products submitted for distribution permits. 

This activity will include evaluation of product formulations, laboratory tests, and other technical aspects according to established standards.

Public Education

BPOM is also active in educating the public about the importance of using products that have been licensed by BPOM. 

This aims to increase public awareness to pay more attention to the safety of the products they’ll consume or use.

Law Enforcement

In addition to overseeing product registration and circulation, BPOM is also authorized to take legal action against violations that occur.

For example, there are illegal (unregistered) products or even products that have been banned still circulating in the market.

With this important role, BPOM acts as the frontline in maintaining the quality and safety of health products in Indonesia.

Requirements to Apply for BPOM License

The answer to the question of how to apply for BPOM license is that you need to complete the requirements.

By fulfilling these requirements, you are making an effort to create quality and safe products for the community.

Here are some of the main requirements that you need to fullfil: 

Product Formulation

Manufacturers should provide clear and complete information on product formulations, including the ingredients used and the dosage. 

Furthermore, this formulation must also comply with the safety and effectiveness standards that has been set by BPOM.

That means, you are not allowed to use raw materials whose types or dosages are not permitted.

Administrative Documents

The procedure of product registration at BPOM also requires the collection of some administrative documents, including: 

• Business licenses
• Halal certificate (if applicable)
• GMP (Good Manufacturing Practice) certification, and 
• Proof of compliance with applicable regulations

Laboratory Test Results

In order to obtain a BPOM license, generally your food, drug or cosmetic product must first pass a laboratory test. 

This laboratory test will be conducted by an accredited institution. The tests include testing the safety, effectiveness, and ingredients contained in the product.

Safety Evaluation

Before granting a license, BPOM will needs to conduct an in-depth evaluation of the safety of the proposed product first. 

This includes assessing the possible side effects and risks of using the product on consumers’ health.

Label and Packaging

Products registered for a BPOM license must have clear labeling and packaging that is safe and not misleading. 

Information on the label must be complete and in accordance with applicable regulations.

Certification

Some health products, such as food and cosmetics, also require halal certification or certification from other relevant institutions. 

This requirement depends on the type of product and its target market.

The Steps on How to Apply for BPOM License

There are several steps on how to apply for BPOM license in Indonesia that you need to follow, namely: 

Product Registration

The first step on how to apply for BPOM license is that you need to do product registration. 

This process varies depending on the type of product you want to register. For example, medicines, food, cosmetics, or medical devices. 

Each type of product may have some spesific requirements and documents that must be prepared before submission.

Document Collection

After determining the product type, the next step is to collect all the documents required for registration. 

These documents may include product formulations, laboratory test results, safety certifications, and production permits from the authorities.

Application Submission

After completing all of the requirement documents, you can officially submit the application to the BPOM agency. 

You can do this submission online through a system that has been provided to facilitate the administration and monitoring process.

Administrative and Technical Examination

After the BPOM received your application, they will conduct an administrative examination of the submitted documents first. 

If the administrative documents are complete, then BPOM will continue to conduct a technical examination of the product concerned. 

This examination includes laboratory tests, formulation evaluation, and other technical aspects in accordance with applicable standards.

Risk and Safety Evaluation

The last step on how to apply for BPOM license is evaluating the risk and safety of the proposed product.  

This aims to ensure that the product does not endanger consumer health and meets established safety standards.s

Issuance of Circulation Permit

After the product passes the inspection and evaluation process and is declared qualified, BPOM will issue a distribution permit. 

Once you have this BPOM license, you are now allowed to sell and distribute your products in the market freelys. 

So, knowing how to apply for BPOM license is important for manufacturers and distributors of health products in Indonesia. 

This process not only ensures compliance with regulations, but also maintains the safety and quality of products in the market. 

By understanding how to apply for BPOM, manufacturers can ensure that products are legally recognized and safe for consumption.