Understanding the Basic BPOM Rules of Medicine & Drugs Importation in Indonesia

There’s always one rule that always applies to medical products imported under BPOM. In Indonesia, each type of medical device and medical supply imported with one trade name/brand originating from the principal can only be represented by one importer.

It is the duty of a state to protect all its people. In the health sector, for example, the state has a hand in selecting every drug, device, competency, and other matter related to health. It is undeniable that the different health technology competencies of each country require each one of them to import drugs, equipment, competencies, and other things related to health.

This is where the role of the Government of the Republic of Indonesia which includes the BPOM organization point of view comes into play, to ensure that imports that occur in the country have the appropriate BPOM standards to be circulated in every corner of the country.

Not long ago, a statement emerged from the Coordinating Minister for Maritime Affairs of the Republic of Indonesia, who instructed not to import medical equipment from abroad anymore. Based on the data, out of 358 types of medical devices, only 79 types of medical devices are produced domestically. On the other hand, the pharmaceutical industry in the medical sector is considered sluggish in investment.

Despite all the debates that have occurred, the question arises, “How did this happen?” What are the regulations regarding drugs and medical devices in Indonesia?” To narrow the discussion, this article will examine the basic rules that apply to medicine imported to Indonesia and how vital BPOM’s responsibilities are to the public.

Each Medicinal Product Must Be Checked First Before Submitting a BPOM Application

Before having a distribution permit from BPOM, an imported medicine must first go through the registration stage. The medicines must have a quality that meets the requirements assessed from the production process according to good drug manufacturing methods in Indonesia.

Not all medicines can be imported into Indonesia. Medicine imports are needed for public health programs, new medical developments, and medicines that are needed but still cannot be produced domestically. Then, what are the regulations for importing drugs to foreign corporations in Indonesia?

Imported medicines must first register to get BPOM’s distribution permit in Indonesia and must also have an import certificate or paper called Surat Keterangan Impor, abbreviated as SKI. The registration of imported medicines is carried out by the domestic pharmaceutical industry, which obtains written approval from the overseas pharmaceutical industry (localization).

The written approval must include a technology transfer agreement with the provision that within a period of 5 (five) years, it must be produced domestically. In addition, foreign corporations operating in the pharmaceutical sector must meet the requirements as evidenced by the appropriate documents or, if necessary, a local inspection is carried out by the authorized officer.

Obtaining the Distribution Permit from BPOM

BPOM, which is the short version of Badan Pengawas Obat dan Makanan (National Agency of Drug and Food Control), will check and give the agreement about the imported medicines. Thus, you have to make sure the products are up to BPOM standards and requirements.

Foreign corporations that have met the requirements can register medicines with BPOM. This registration is done on the http://e-bpom.pom.go.id.

If approved, BPOM then releases the distribution permit that is valid for foreign corporations for a period of five years, which can be extended again later on. If rejected, the foreign corporation has the right to conduct a review with BPOM again.

Based on the explanation above, which focuses on provisions for foreign corporations operating in the pharmaceutical sector, what if someone takes it home and uses the medicine they bought from abroad?

Based on the Decree of the Minister of Industry and Trade No. 341/Kp/VIII/1974, a person can buy, take home, and use medicines purchased from abroad as long as they are only used for personal purposes. Even so, the purchase of important medicines is, of course, limited by laws and regulations to prevent commercialization.

In addition to medicines, the provisions of medical devices (including in vitro) and medical supplies are also important things to pay attention to. Imports of medical devices and supplies must also have a distribution permit in which the application includes a certificate of free sale (CFS).

This provision is excluded from medical devices or supplies which are circulated through a special access scheme. According to the Minister of Health, the objects of medical devices and medical supplies that cannot be commercialized are non-new medical devices, which can be in the form of reconditioned and remanufactured goods.

What You Need to Know About Izin Edar/IE (Distribution Permit) from BPOM

Every medicine, food, and beverage product sold in the market must be registered and obtain a distribution permit from BPOM. Then how do you register food and medicine products with BPOM to get the distribution permit? What are the things you need to prepare in order to register your products with BPOM?

What you need to know is that the regulation regarding the distribution permit from BPOM does not only apply to pharmaceutical companies that produce drugs in bulk. BPOM’s permit can also apply to small-scale and home-based businesses if they want to reach a wider market.

In addition to being required to have business licenses such as Extension Certificates or SP and food production certificates for home industry production or SPP-PIRT. IE from BPOM is also required if food, beverage, and medicine businesses want to penetrate a wider market. To get IE from BPOM, you must register your product for clinical trials to determine whether it is safe for consumption or use by consumers.

Before proceeding further into the discussion, please note that food, beverage, and medicine manufacturers who wish to market their products widely are required to have an IE issued by BPOM. This permit from BPOM is based on Regulation of the Head of the POM Agency number 27 of 2017 concerning Processed Food Registration as a guarantee to consumers that the products sold are feasible and safe for consumption. It is important to note that having an IE from BPOM can be extremely beneficial for your business. But why is that?

The advantage of having IE from BPOM is that if a product from the food, beverage, or medicine business, when investigated by the POM Agency, is indicated as dangerous for consumption, the producer can immediately fix it. As a result, owning an IE from BPOM can help you in improving and assuring customers about the safety of your products.

If you sell your product to the wider market without obtaining permission from BPOM, or if your product is found to contain ingredients that are harmful to consumers, you must be prepared to deal with the authorities.

Thus, first thing first, it is a priority to obtain permission from BPOM for your products. By having a distribution permit from BPOM, in addition to convincing consumers of the safety of your product, you also don’t have to worry if something unwanted happens to your product.

Steps to Obtain Distribution Permit

Since we understand the value of acquiring permission from BPOM, what are the things you need to do to get a distribution permit? There are several steps that must be taken to obtain a distribution permit from BPOM:

1. The first thing before registering a product with BPOM is first to prepare your product along with the required documents.

For products imported from abroad, aka with product code ML from BPOM, what needs to be prepared are:

  1. Copy of certificate from the Ministry of Health or health certificate from the country of origin.
  2. The results of the laboratory test of the country of origin.
  3. Colored labels.
  4. Sample product minimum of three pieces,
  5. List of compositions and specifications of product raw materials.
  6. Copy of trading business license and
  7. General importer identification number

2. Register your business entity with BPOM first before registering the product to be tested for IE. Registration of business entities can be done online by accessing the e-BPOM registration page at http://e-bpom.pom.go.id/.

3. Once it is registered with BPOM, you must provide proof of payment. The evidence of the payment that the company has made needs to be uploaded to the e-BPOM page by logging in first. The proof of payment will then be verified along with product registration application data and product label designs.

About Medical Device Product License from BPOM

Do you also need a permit from BPOM for your medical devices? In contrast to the distribution permitted for medicines, the distribution permit for medical devices is issued by the Minister of Health, not BPOM. Instead of BPOM, an Application for a distribution permit for medical devices can be made by:

  1. Sole agent/sole distributor;
  2. Medical device distributors and health supply importers who have a letter of appointment from the manufacturer or principal and are authorized to register medical devices
  3. Medical device importers who own products that have a cooperation agreement with the manufacturer;

Medical Device Product License Legal Terms

There are legal terms that are important to know before the discussion continues.

First, the distribution agent is a company in the form of a legal entity in the form of a limited liability company or cooperative that has a license for the procurement, storage, and distribution of medical devices.

Second, the principal is the manufacturer or the product owner to appoint importers in Indonesia. The agreement between itself is a type of agency agreement.

Applications for distribution permits for medical devices and PKRT are carried out online through the Indonesia national single window portal or website with the address regalkes.kemkes.go.id, followed by the fulfillment of the technical and administrative requirements attached in Attachment II to the Permenkes of Circulation Permit for Medical Devices.

For the record, each type of medical device and health supply imported with one trade name/brand originating from the principal can only be represented by one importer.

If approved, the distribution permit will be valid for five years and can be extended. Circulation of medical devices and supplies must be accompanied by marking of medical devices and in vitro as a form of safety, benefit, and instructions for the use of medical devices and supplies.

And that’s all about the basic rules and additional things to know about medicine imported in Indonesia. Hope it can clear your mind away from all the confusion. Have a good day!

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