BPOM Guide on How to Register Your Food, Medicine, and Cosmetics Products in Indonesia
As a country with 270 million people and the 4th most populated country on earth, Indonesia is a highly prospective place to market new products, especially in the food, medicine, and cosmetic categories which are always in high demand and needed by everyone everywhere. However, just like in any other country, to be able to sell a product in Indonesia the company must have a license and passed the certification process which is authorized by the local regulatory body. In Indonesia, the registration process for food, medicine, and cosmetics products is handled by the National Agency of Drug and Food Control (NA-DFC) which is known as Badan Pengawas Obat dan Makanan (BPOM) in Bahasa.
Contents
What is BPOM?
BPOM is a national government agency that is responsible for protecting and maintaining public health in Indonesia, through the control as well as supervision of food and drug products that are being sold in the market. The main duty of BPOM is to conduct government duties in things related to drugs along with food control according to the provisions laws and regulations.
The agency has several functions, among them are the following:
- Assess and formulate national policies in regards to drug and food control
- Implement policies in regards to drug and food control
- Prepare and stipulate norms, standards, procedures, and criteria in the field of control pre-distribution and control during distribution
- Coordinate functional activity in BPOM tasks implementation
- Monitoring and guiding government agencies activities in regards to drug and food control
- Take action against violations of the provisions of laws and regulations in the field of drug and food control
Why do You Need BPOM Registration & License in Indonesia for Distribution?
There are several products category which must have BPOM certification or distribution permit before being sold or distributed in Indonesia, which is the following:
- Therapeutic products including pharmaceutical drugs, vaccines, biopharmaceuticals
- Drug ingredients
- Narcotics
- Psychotropic
- Precursor
- Addictive substances
- Traditional medicines
- Health supplements / complementary products
- Cosmetics
- Processed Food
That being said, if your products fall into one of those categories and don’t have a BPOM license, not only it will instantly lose the consumer trust towards your product’s quality but your products can also be withdrawn from the market by the authorized party and face legal consequences. Even if your products already have a license in their origin country, you still need a BPOM distribution permit when you want to sell the products in Indonesia.
Having a BPOM license for your product can help you to gain numerous benefits for your company, such as:
- Products can be marketed and distributed legally in accordance with the applicable regulations in Indonesia
- Ensure the products comply with the safety and quality regulatory requirements
- Increase product’s competitiveness in the market
- Boost public trust in your products
- Expand marketing of your products both inside and outside the country
- Gain added value for your products
How to Get Your Product Registered in Indonesia for BPOM?
In general, both products that are produced locally in Indonesia and products that are imported can be submitted to BPOM. Domestic Products will be registered as “MD” and Overseas Products will be registered as “ML”.
The product registration to BPOM can be conducted either by manufacturer, distributor, or importer. However, it is important to note that only local company that can register the product in BPOM. Thus being said, the foreign manufacturer can also register their products by creating a foreign-owned company or known as PT PMA in Indonesia, but selecting a local importer and distributor instead of creating such a company will be much easier and can be a less complicated option to choose for.
The requirements for BPOM registration can be slightly different depends on the type of products and where they are produced (i.e. in Indonesia or imported), as each product has its own regulations and requirements. Generally, the registration will require both administrative documents and technical documents. Administrative requirements for Domestic Products (MD) will consist of industrial business license, audit result of production facilities, taxpayer identification number, deed of incorporation. Foreign Product (ML) will require a letter of appointment (LoA) from the company of origin country to the importer and distributor, health certificate, trade business license and import identification number, GMP or HACCP, or ISO 22000 Certificate or Audit Certificate from the local government for the origin factory. The technical requirements of the registration will consist of technical aspects of the product, such as product composition and production process, production period, code, label, packaging, ingredients, shelf life, and specification.
(Please contact our representative for more details on the requirements needed to be prepared prior to BPOM registration).
What is the Procedure for BPOM Registration?
BPOM registration is consisting of several steps and processes, and the registration can be conducted online through the official BPOM website. Prior to product submission, you must first register the company which will perform the registration. Once the company has been registered, then it can proceed to register the products that will be submitted and send all the forms and registration documents needed.
The following is steps that you will go through once you register your product to BPOM.
- Submission
- Audit
- Assessment
- Evaluation
- Authorization
The length of time required for BPOM registration can vary depends on the type of products registered, completeness of the requirements fulfilled by the register, and also the time of the audit process. The more complicated and high regulated the product, then the more requirements and time it needed to be authorized (e.g. drugs, vaccine, etc.). We can help you to ensure that all the requirements needed for the registration have been fulfilled in order to have a more successful BPOM registration.
Once you have successfully obtained a Circular Permit from BPOM, the permit will be valid for 5 years, and it can be extended within the period of six months before it expires.
Contact Us for BPOM License Service
Registering a product to BPOM can be a quite hassle and tough task, especially if one is not very familiar with how the systems work in Indonesia. Our company can help and assist you to register your product in Indonesia, starting from the consultation before submission to choose the best option for your company, checking and making sure that you have all of the requirements needed, as well as guiding and assisting you in the next step of the registration process.
If you have any inquiries and questions regarding the BPOM registration process, feel free to ask us and our staff will be delighted to support and give the solution to your needs.
