Open a Pharmaceutical Company in Indonesia

Updated on Wednesday 24th January 2018

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Until a few years ago, the Indonesian pharmaceutical market wasn’t as development as the markets of other neighboring countries. In 2014, the Indonesian government has enabled the national health insurance program and the number of pharmaceutical companies has started growing.

Presently, the pharmaceutical industry in Indonesia is predominantly made up of companies producing and selling generic medicines, food supplements. Innovation in the pharma industry is in the beginning, as only 2.5% of the medicine products manufactured in Indonesia are innovative.

If you want to open a pharmaceutical company in this country and need information on the requirements, our company formation agents in Indonesia can guide you.
 

Legislation applicable to pharmaceutical companies in Indonesia

The main law providing for manufacturing, licensing and sale of pharmaceutical products is the Regulation No. 1010/XI/2008 on Registration of Medicines issued by the Ministry of Health. All activities of pharmaceutical companies registered in Indonesia are supervised by the Food and Medicine Supervisory Board (BPOM).

The first step to open a pharma company in Indonesia is to register one of the available types of structures allowed by the Commercial Code and then start the licensing procedure.

Our company registration consultants in Indonesia can assist with the incorporation of the chosen business form with the local Trade Register.
 

Pharmaceutical licenses in Indonesia


Once the company in registered, the pharmaceutical company must apply for a drug distribution license with the BPOM. In order to obtain the license, the company must provide information such as:

-          the product is safe for use;
-          it respects the Good Medicine Manufacturing Practices;
-          it satisfies the public necessity requirement.

Pharmaceutical companies producing medicines in Indonesia must also obtain an industrial business license.

In the case of imported medical products, these must be registered by local companies which have previously obtained a written approval from the foreign producer.

If you are interested in starting a business in the pharmaceutical industry in Indonesia, please feel free to contact our local advisors if you need assistance.
 

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