BPOM Certification & License for Foreign Companies

The Indonesian Food and Drug Administration, also famously known as FDA (Badan Pengawas Obat dan Makanan in Indonesian) or Badan POM (BPOM), is one of the government branches that is responsible for the public health safety. The BPOM acts as a regulatory and executive body that oversees the approval, sale, and distribution of pharmaceutical and over-the-counter medicinal drugs (medications), vaccines, specialty chemicals, food supplements, food standards, herbal medicines, and cosmetic products all across Indonesia. They are also responsible for granting permissions to imported products that can be categorized as the ones mentioned above.

To put it simply, the following are the main roles of the BPOM in Indonesia:

  1. Developing new regulations, procedures, standards, as well as criteria for all food and drug administration.
  2. Regulations, standards, procedures, and criterion implementations, which then followed with supervision.
  3. Current regulations, procedures, standards, and criteria updates.
  4. Building, manufacturing, and distribution facilities inspections, as well as sampling products.
  5. Product testing that is conducted in laboratories
  6. Granting certificates and permits.

Contents

1. What Are The Things You Need To Know About BPOM To Sell Your Goods to Indonesia?
2. Notification for Registration in BPOM
     2.1 BPOM Cosmetic Notification
     2.2 BPOM Health Supplement Notification
     2.3 BPOM Food Notification
3. Procedure for Registration in BPOM Website to Obtain SKI
     3.1 All The Things You Need to Know For Importing Vaccines to Indonesia
     3.2 All The Things You Need to Know For Importing Generic Drugs Over The Counter
     3.3 All The Things You Need to Know For Importing Packaged Foods to Indonesia
4. Recent Updates on Achieving SKI Online in 2020
5. Online Supply of Medicines and FSMP
6. Procedures Foreign Companies That Want to Sell Medicines, Drugs, and Cosmetics to Indonesia
7. What We Can Offer For You to Help You Register at The BPOM
8. Contact Us and Book an Appointment

bpom product distribution license to IndonesiaWhat Are The Things You Need To Know About BPOM To Sell Your Goods to Indonesia?

Law No. 27 of 2013’s law on the control of drug and food imports into Indonesian territory, which went into effect on the 28th of May 2013, applies to all kinds of drugs, cosmetics, and food items. This law is applicable to current implementations as well as regulations, therefore older versions are no longer valid and aren’t really relevant anymore.

Wholesalers of drugs and food all require the approval of the Head of BPOM in addition to the distribution permit (also known as Izin Edar in Indonesian) and all other important and well-needed conditions under the current import regulation. Imports into free trade zones and free ports are also subject to this condition.

It is important to know that in order to gain the approval of the Head of the BPOM, imported items must meet the following storage requirements:

  1. Medication, alternative cures, nutritional supplements, and cosmetics should all have at least ⅓ of their shelf life.
  2. For agricultural items, there should be at least a spare of 9 months before they went into expiration.
  3. For packaged foods, at least ⅔ of the shelf life must be provided.

Notification for Registration in BPOM

In Indonesia, the basic standards for registering food and beverage, medical types of equipment, health supplements, and cosmetics, are all basically the same. The applications start online with procedures of creating an account for Cosmetics and Food products undergoing a similar process.

BPOM Cosmetic Notification

It is critical to consider various registration for each variety of cosmetic products. Different types, shades, and colors, all need to be registered with the BPOM without an exception. You also need to consider other important aspects such as labeling, advertising, and claim requirements.

How to create a company account for cosmetics products:

  1. Filling out the online registration form through https://notifkos.pom.go.id
  2. Submitting administration requirements to NADFC
  3. Once the administration requirement is met, the company account soon will be activated.

Administration requirements you need to submit for your imported product:

  1. Business Identification Number / NIB
  2. Directors’ and/or company leader’s Residence Identification Card
  3. Directors’ and/or head of the company’s statement must have no involvement with any criminal conduct in the cosmetics filed
  4. Business License
  5. Letter of Authorization
  6. Taxpayer Identification Number
  7. Letter of Recommendation as a notification applicant
  8. A letter of the contractual agreement between the manufacturer and the applicant that is legalized by a notary outside of Indonesia
  9. For manufacturing facilities in the ASEAN region, a Good Manufacturing Practice Certificate or Declaration of Good Manufacturing Practice is required
  10.  A Certificate of Free Sale (CFS) is granted by an authorized official or organization recognized by their home country and legalized by the local Embassy/ Consulate General of the Republic of Indonesia, not including contract for cosmetics
  11. A Good Manufacturing Practice Certificate is provided by an authorized official or organization recognized in the home country and legalized by the local Embassy. Consulate General of the Republic of Indonesia for manufacturers outside of Indonesia that have received a production contract
  12.  If the Good Manufacturing License is granted by an accredited certification body, a Cosmetic Manufacturer License is also required
  13. Letter of agreement between applicant and license holder (applicable for the licensed product)
  14. Brand Certificate (if any)
  15. Brand’s declaration letter

The notification fee for all cosmetics manufactured outside of ASEAN countries is IDR 1.500.000. As for all cosmetics manufacturers in ASEAN countries, the notification fee is IDR 500.000.

After receiving the product’s license number, products then can finally be distributed and sold, which are only valid for three years. Upon notifications of the expiration period, applicants must renew their notification number by going through the renewal notifications procedure.

BPOM Health Supplement Notification

As for health supplements, it is defined by the BPOM as products that are meant to complement nutritional needs, and maintain and improve health function. It is also described to have nutritional value and/or physiological benefits. Thus, several things need to be considered before going further into product registration.

One of them is the need to understand the categorization of health supplements into different types, as the following:

  1. Category 1: health supplements having one or more of the following ingredients: vitamin, carbohydrate, mineral, protein, fat, amino acid, or other materials in the form of isolates.
  2. Category 2: health supplements having one or more of the following ingredients: vitamin, carbohydrate, mineral, protein fat, amino acid, other isolates, as well as other natural materials.
  3. Category 3: health supplements that are considered to be from categories 1 and 2 with an additional claim of having a new preparation form, dose, usage, or posology.

BPOM Food Notification

Even though all food and beverage goods are considered to be any product whether it is derived from biological sources or not, not all food and beverages required registration from the BPOM. To be simple, only ones presented as packaged food, like as-seen-on-tv frozen meals are in need of a BPOM registration.

Just like the health supplements from before, you need to consider different categorizations of food and beverage. This categorization is mainly based on their risk levels, which are:

  1. Very Low Risk: comprises few ingredients and is lightly processed, with no animal derivatives or food additives, such as frozen vegetables and olive oil.
  2. Low Risk: such as jam, cereals, and instant noodles.
  3. Medium Risk: often on processed food that has been through sterilization, pasteurization, and irradiation, such as gluten-free foods and canned food.
  4. High Risk: often on some processed food that is targeted towards consumers with specific health conditions, such as meals for pregnant mothers and baby food.

How to create a company account for Food products:

  1. Filling out the online registration form through https://e-reg.pom.go.id
  2. Wait for the registration to be approved by the BPOM officer
  3. Once the documents are approved by the BPOM officer, the company account soon will be activated.

Administration requirements you need to submit for your imported product:

  1. Tax Identification Number / NPWP
  2. Business Identification Number /NIB
  3. Results of distribution facility audit (PSB) / Recommendation from local BPOM (for importer)
  4. Results of production facility audit / Recommendation from local BPOM (for local applicant)
  5. Business License (IUI / IUMK / SKDU /SIUP / API / Letter of Determination as a Registered Importer (Importir Terdaftar or IT) for alcoholic beverage
  6. Applicant must use the IUI granted by the central BKPM for beverage products
  7. Health certificate or CFS issued by the country of origin
  8. For products that are produced outside of Indonesia, a Letter of Appointment (LoA) that is already legalized by a Notary, local government, or Representatives of the Republic of Indonesia abroad, is required.
  9. API / Importer Identification Number (for importer)
  10. A production flow chart or GMP Certification / HACCP / ISO 22000 (for local applicant)
  11. Composition or list of materials that includes information of origin or certain raw materials and/or BTP (food additives)
  12. Shelf life information
  13. Label Design
  14. Production information code
  15. For products that are produced outside of Indonesia, GMP Certification / HACCP / ISO 22000 / Audit Certificate, is required
  16. Material specifications
  17. Certificate of Analysis (containing information on microbial and heavy metal contamination, characteristics, and nutrition)

The fee for new registration is IDR 200.00 to IDR 3000.0000 as stated in the Peraturan Pemerintah Republik Indonesia Nomor 32 Tahun 2017.

After receiving the product’s license number, products then can finally be distributed and sold, which are only valid for five years. Upon notification of the expiration period, applicants must renew their notification number approximately 3 months before the expiry date.

Procedure for Registration in BPOM Website to Obtain SKI

To facilitate the needs of the candidates, the legislation has established an online approach for importers to obtain a SKI from the Head of the BPOM. First of all, candidates must enroll on the BPOM official site by uploading an online application form together with the required supporting documentation in order to acquire a user ID and password.

The documents that trading companies must submit by electronic documentation (pdf files) to begin the application process are the following:

  1. The shipment’s license’s approval.
  2. The billing documents.
  3. List of packaging.
  4. The research documents
  5. Documents containing prove of paid non-tax State Revenue (Penerimaan Negara Bukan Pajak)
  6. The shipment’s billing documents, or if applicable, an airway invoice.

Each of those documents has its own set of requirements. You can contact our consultant to gain additional information and ask for assistance on how to make a great application to obtain a SKI.

All The Things You Need to Know For Importing Vaccines to Indonesia

The application for a SKI for vaccines must also be accompanied by (a) the shipping clearance registration certificate issued by the exporter’s recognized institution, and (b) the batch/lot evaluation set of lists that are submitted by the manufacturer. Following that, the BPOM then can also examine and evaluate the content of the vaccine.

All The Things You Need to Know For Importing Generic Drugs Over The Counter

For generic pharmaceuticals, quasi-drugs, cosmetics and beauty goods, and dietary supplements, the product name on the invoice must first match the name stated on the SKI Distribution license. Applications of SKI for cosmetics products may be exempted from these requirements, but first, the manufacturer must file a declaration.

All The Things You Need to Know For Importing Packaged Foods to Indonesia

To apply for a SKI for packaged foods, companies are often required to meet the following legal requirements:

  1. An authorized mark at the time of registration.
  2. For processed goods made from animals, there needed to be a letter of advice from the Minister of Agriculture
  3. A declaration from the manufacturers of where the exporter and the producer are two separate parties, or where the imported documents and the delivery licenses do not include the same name for the packaged food, is required.
  4. Any further accreditations that are necessary by law (if there are any).

Recent Updates on Achieving SKI Online in 2020 Onwards

The Indonesian Food and Drug Administration (BPOM) recently released a Regulation on the Supervision of the Online Delivery of Food and Drugs, specifically Regulation No. 8 OF 2020 (Reg. 8/2020) [1], which aims to protect the public by establishing ground rules for the online distribution of pharmaceutical products, conventional medicinal products, dietary additives, cosmetics, processed foods, and other food products.

The regulation defines the “online food distribution and drugs” as any operation or sequence of activities related to the distribution of any of the above-listed items through electronic trading and lays out the requirements that must be met for each type of product’s digital distribution. This includes the requirement to obtain a delivery and distribution authorization for each product.

Online Supply of Medicines and FSMP

Internet distribution of medical drugs and FDMP can only be done by approved pharmacies that conform with suppliers of pharmaceutical electronics or ESP, according to Reg. 8/2020. The law outlines hospitals’ pharmacy ESPs’ responsibilities to deliver their products electronically, including the need to check prescriptions and drug conditions, as well as to maintain records.

Both pharmacies and pharmacy ESPs are prohibited to sell the following set of medicines:

  1. Drugs that contain a pharmaceutical precursor
  2. Erectile Dysfunction Medicines
  3. Injecting supplies instead of insulin
  4. Pain relievers, psychiatric medicines, and provision of implants, in which the use includes assistance from health care professionals.

It’s important to note that it is also strictly prohibited to sell drugs and FSMP through social medical, regular sales, and classified advertising.

Procedures Foreign Companies That Want to Sell Medicines, Drugs, and Cosmetics to Indonesia

Suppose you are a foreign corporation planning to launch a business in Indonesia or wish to export your products to Indonesia to sell them. In that case, you will need a local partner to help you distribute your goods. This partner is commonly known as PT PMA.

If you are a local company interested in registering your food products, you can also help us to understand more about the details of your application process and documentation.

In summary, the following are the general documents that you must submit as a foreign company trying to expand your products in Indonesia:

  1. Data on imports.
  2. Approval of consumer food registration.
  3. Perfectly sealed and signed Letter of Declaration

(Must be noted: Products are not meant for retail sale, food items with an identification number are exempt).

  1. Analysis Certification (QC Report) Health Qualification / Sale Certificate from the appropriate authority in the country of origin (for any additives and raw ingredients).
  2. Product specification includes:
    • Product definition, formulation, or ingredients.
    • Physical, chemical, or microbial features of products.
  1. Both packing lists and billing.

What We Can Offer For You to Help You Register at The BPOM

As a trusted agency, with much expertise that you can work with, here are several instances of how Mandreel can help you obtain approval for SKI from the BPOM:

  1. Mandreel is ready to assist you with the online and offline paperwork that is required for importing goods into Indonesia in accordance with the BPOM checklist.
  2. Mandreel will provide you with consulting services for a wide range of businesses, starting from micro-sized to large firms. We have a team of experts dedicated to each of the categories to help you maintain your market growth while still complying with the regulations.
  3. We had hundreds of customers coming from Singapore, Malaysia, and Indonesia, thus we are very well-versed in the Indonesian market and the countries of the possible importers.
  4. We also worked well with a variety of organizations, including the chemical, pharmaceutical, food, and FMCG industries.
  5. And last but most importantly, we are here to help you with every stage of the BPOM registration process necessary for importing into Indonesia.

Contact Us and Book an Appointment

If you are interested to work with us or still have any other queries about our services, feel free to send us an email and we will get back to you as quickly as possible. Mandreel takes care of everything for you. To handle all of your paperwork and through any registration process. Drop us a message and we will soon be in contact with you!

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