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The Food and Drug Supervisory Agency or BPOM is one of the government agencies responsible for monitoring food and drugs in circulation. Well, for MSME players, especially those whose businesses are engaged in food and medicine, it is necessary to apply for a BPOM permit. Because, this BPOM distribution permit is an official sign that the quality of your product is guaranteed and free from harmful content for consumers. Yes, with this BPOM distribution permit, consumers will get legal certainty over the processed products they consume. For business actors, legal certainty in the form of a BPOM distribution permit can also make it easier to reach a wider market, even abroad. So, how can businesses in the food sector and MSMEs apply for a BPOM license? What documents are needed? Let’s see the following review!

What is BPOM?

As already explained, BPOM itself is the Food and Drug Supervisory Agency, which is an agency authorized to oversee the circulation of food products and medicines in Indonesia. The aim is to protect the safety, security and health of consumers. The government itself has determined the duties of this BPOM institution where based on Article 2 of Presidential Regulation No. 80/2017, the duties of BPOM are:

  1. Carrying out government duties in the food and drug control sector in accordance with the provisions of laws and regulations.
  2. Drugs and food consist of various types, namely drugs, medicinal materials, narcotics, psychotropic substances, precursors, addictive substances, traditional medicines, health supplements, cosmetics, and processed food.

So from this article we can conclude that BPOM is an institution that has the main task of organizing government affairs in the field of drug and food supervision. BPOM also ensures product supervision before and during circulation in the market as a legal precaution to ensure that drugs and food in circulation have met the standard requirements for safety, benefits, and also the quality of the product is determined. If there is a violation, BPOM will also conduct investigations and inquiries, as well as conduct product certification and evaluate and compile drug and food test reports.

The Importance of BPOM Permits for MSME Actors

There are still many beginner MSME players who only focus on production and sales in order to quickly get profits. Most of them underestimate and reason that the ingredients used for production are very and do not contain hazardous ingredients, so there is no need to register products with BPOM. In fact, legality in the form of BPOM permits is also important, especially if MSME players sell food and medicine products, including cosmetics. Selling products ranging from food, makeup, to skincare can be considered dangerous and confiscated by the authorities if there is no BPOM permit. Therefore, in order to sell safely and products remain in demand in the market, as an MSME player, KH Friend needs to register your selling products with BPOM. With selling products that have been registered with BPOM, MSME owners will also get many benefits, including:

  • Legality that will guarantee product quality
  • As a safety guarantee for a product
  • Price stability of BPOM-authorized products
  • Product image will be improved compared to competing products that have not been licensed by BPOM.
  • Easily reach a wider market, even overseas

Type of BPOM Permit

The distribution permit owned by BPOM has three types of labels, namely SP, MD, and ML. The following is a brief explanation of the three types of licenses:

  • SP Label

The SP label or what is commonly referred to as an Extension Certificate is a label given by the Health Office to small-scale entrepreneurs or what is commonly referred to as MSMEs.

  • MD Label

The MD or Deep Food label is given directly by the BPOM agency to large companies that produce food and beverages that have met the qualifications and requirements.

  • ML Label

ML or Foreign Food label, specifically made for products imported into Indonesia with a record of having met the requirements in accordance with BPOM rules. This label is also given to products that are directly marketed in Indonesia as well as products that have been repackaged.

What are the requirements to apply for a BPOM license?

Before registering for a BPOM distribution permit, make sure your KH Friend has prepared several important documents as BPOM registration requirements. The required documents include:

1. For Domestic Products

  • Completed registration form
  • Industrial License (Industrial Business License (IUI)/Industrial Registration Mark (TDI)/Izin Usaha Mikro Kecil (IUMK))
  • Production facility audit results/Risk Management Program (PMR) Charter/Certificate of Good Processed Food Production Practices (CPPOB)
  • Power of Attorney

2. For Imported Products

  • Appointment letter from the factory (original document and photocopy)
  • Health Certificate (original document and photocopy)
  • Laboratory results valid 6 months after testing
  • Label design
  • Completed form

Other Supporting Documents (If Required)

  • Brand certificate
  • Product certificate of SNI (Indonesian National Standard) mark usage
  • Description of Genetically Engineered Food Products for raw materials such as beans, soybeans, corn, and tomatoes
  • Organic certificate (if organic logo is included)
  • Halal certificate (if the label includes the halal logo)
  • Description of food irradiation (if processed by irradiation)
  • Veterinary Control Number (NKV) for Slaughterhouse (RPH)
  • Other supporting data

How to Apply for BPOM License?

Now, BPOM has provided a special platform for KH friends who want to apply for a BPOM distribution permit online, namely e-BPOM. Launching the e-BPOM website, this application aims to facilitate public services in terms of the drug and food licensing process. The following are the types of products served:

  • Importation of Finished Medicines
  • Medicine Raw Materials
  • Raw Materials and Traditional Medicine Products
  • Cosmetics
  • Complementary Products
  • Food Raw Materials
  • Food Products within BPOM Republic of Indonesia

Now, to apply for a BPOM license online, KH Friend just needs to follow the steps as follows:

  1. Visit the website https://e-bpom.pom.go.id/, or download the e-BPOM application through the Apple Store and Play Store
  2. On the main page, find the Food e-Registration section and click Login.
  3. Fill in the product data information, raw materials, analysis results, and Nutritional Value information on your product.
  4. If all parts of the form have been filled in, upload all the required documents.
  5. Send the uploaded physical documents to the BPOM office address listed on the registration page.
  6. After that, Friend KH will undergo the process of verifying the application data and label design.
  7. Make license payment according to the Payment Order (SPB)
  8. Upload proof of payment
  9. Wait for validation process from BPOM
  10. After that, a Registration Approval Letter (SPP) will be issued.
  11. If the SPP has been issued, KH Friend will also be asked to submit physical files regarding the label design and proof of payment to the BPOM office.
  12. Wait for the Number of Edar License (NIE) after 30 days from registration

How much does it cost to apply for a BPOM license?

Given the lengthy process and the need for clinical trials to ensure that the products sold are safe for consumption and use, the BPOM license registration is subject to a fee. This fee will be included in the Non-Tax State Revenue (PNBP). Here are the fees:

  1. Registration at BPOM starts from IDR 100,000 for medicinal products and from IDR 100,000 per product for food.
  2. The notification service for cosmetics produced outside ASEAN starts from IDR1.5 million per item, while those produced in ASEAN countries are IDR500 thousand per item.
  3. To renew after the five-year validity period, there is a fee of Rp1 million per item for traditional medicine small businesses and Rp5 million per certificate for Good Manufacturing Practice (GMP) certification.

That’s the discussion this time about BPOM licenses for MSMEs. Given the importance of this distribution permit, for that before the product is sold, make sure you immediately register the legality of the product with BPOM, especially for food products, medicines, cosmetics, and skincare. Before registering, also make sure that KH Friend prepares the complete set of required documents. If the BPOM permit has been pocketed, consumers will be more confident because the safety of consumption is guaranteed. This makes your business smoother, and your sales turnover can increase!

KH Contact

Well, for KH pals who are currently working in the food, medicine, and cosmetics business, and plan to register a BPOM license, you can consult first with Kontrak Hukum. Kontrak Hukum is the first digital platform in Indonesia that provides trusted, affordable, and most comprehensive legal services, one of which is related to licensing needed in trading businesses.

READ ALSO: This is the difference between BPOM and SPP-IRT Edar License!

If you have further questions about BPOM licenses or other business needs, you can visit https://kontrakhukum.com/semua-layanan/ or contact us via the following link Ask KH and via Direct Message (DM) to Instagram @kontrakhukum.

Mariska

Resident legal marketer and blog writer, passionate about helping SME to grow and contribute to the greater economy.

Konsul Cabang Surabaya
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