• February 29, 2024

Is it Easy to Apply for BPOM for Your Medicine Products in Indonesia?

The overall process is easy, but it takes time. Plus, if you don’t work with someone or an authorized import organization in Indonesia, the process will be longer than expected. 

Why is BPOM Certification Important for Indonesian Customers?

To conduct business in Indonesia, any company selling food, drinks, cosmetics, or medications must comply with the country’s food safety standards. All food, drinks, cosmetics, and medicines sold in Indonesia must be registered with the Food and Medicine Supervisory Board in compliance with Indonesian government legislation via Badan Pengawas Obat dan Makanan or BPOM.

A fine of Rp1 billion and up to two years in jail may be imposed for selling and distributing items in Indonesia without a BPOM certification license. 

The Purpose of the BPOM Certification License

  • Making sure that the product follows good manufacturing practices;
  • Product examination before it is allowed to circulate;
  • Product regulation and standardization.
  • Monitoring of the product’s safety after it has been released for public consumption, including sampling and laboratory testing, inspections of production and distribution facilities, as well as investigations and law enforcement; \
  • Control of the product advertising and promotion pre- and post-audit

Who Is Eligible To Obtain A BPOM Certification?

BPOM certification license is required for any Indonesian firm selling or distributing processed food and beverage goods, cosmetics, or medicines (including traditional and cosmetical pharmaceuticals). How to get a BPOM certification depends on whether the product is made locally or brought in from somewhere else.

In order to import its goods into Indonesia, a foreign corporation must either license its products to an Indonesian company or create a legal organization in Indonesia. You don’t have to apply for a BPOM certification license if you select for licensing; the importing firm will.

We highly urge that you have an excellent connection with the importing firm if you decide to choose this route. The importing firm may still be able to sell your goods in Indonesia until their certification license expires in the case of a breakup of the relationship. Make an appointment with Permitindo if you have any questions or concerns about the structure of your company.

Obtaining an Import Certificate (Surat Keterangan Impor)

Importers must also get an Import Certificate (SKI or Surat Keterangan Impor) from BPOM in addition to a BPOM certification license under the present import legislation. For an imported product to be marketed in Indonesia, it must fulfill the following storage life requirements:

  • At least a third of the product’s storage life for cosmetics
  • At least 9 months before the expiration date for biological products;
  • At least two-thirds of the product’s storage life for processed foods.

For example, if a product has a total storage life of 18 months, it cannot be sold in Indonesia if it has less than 6 months of storage life left).

e-BPOM can only be used to request an Import Certificate (SKI) if your BPOM certification license has already been issued. BPOM will give your SKI within 1-2 business days if your SKI registration is successful.

Ann Andres

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