Standards and Regulations

question

Our company plans to procure an antidote to treat a type of poisoning (a hazardous substance produced during mining) that cannot be sold in Indonesia. This medicine can only be purchased from abroad, but it lacks a distribution license in Indonesia. A supplier (PT ABC) has indicated it can provide or import the medicine, but this company does not have a distribution license and is neither an official distributor nor an authorized agent. Given the importance of this medicine to our company, is it possible for us to...PT ABCDid the company purchase the antidote without a distribution license? All import licenses and customs clearance procedures were handled by...PT ABCThe company handles the process, and then our company purchases the antidote?

Answer Summary

Before answering your question, let's assume that the antidote you mentioned falls under the category of "medicine," which is defined as follows:

Based on this definition, we assume that the drug you are referring to is for human consumption.

Furthermore, based on the information you provided, the antidote you used must be imported, as it was not manufactured in Indonesia. According to Article 2 of Regulation No. 27/2022 of the Indonesian Food and Drug Administration (BPOM), medicines and food imported into Indonesia for distribution must hold a distribution license and comply with relevant laws and regulations.

Furthermore, drug imports can only be carried out by the distribution license holder or their agent. The drug distribution license holder may authorize other pharmaceutical companies, drug importers, or government agencies to import drugs.

A distribution license is a form of approval for the registration of pharmaceuticals, natural medicines, quasi-pharmaceuticals, health products, and processed foods, or a notification of approval for the distribution of cosmetics, processed foods, and processed foods in Indonesia.

• Border import permits (SKI) for imported pharmaceuticals, natural medicines, quasi-pharmaceuticals, health products and cosmetics;

• Or it can be used for border import certificates (SKI Post Border) for imported processed foods.

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Given that we assume the antidote you mentioned falls under the category of "medicine," for simplicity, its import requires a Border Import Certificate (SKI). What is a Border Import Certificate (SKI)? A Border Import Certificate (SKI) is an approval letter for goods to be imported into Indonesia. It must be obtained before the goods leave the customs area to regulate the distribution of medicines and food.

This Border Import Permit (SKI) is valid for a single entry only and must be obtained when submitting the import application to the authorized agency. So, who needs to apply for a Border Import Permit (SKI)? Companies holding distribution licenses, government agencies, and importers authorized by distribution license holders can apply for a Border SKI (Special Import Permit) to import pharmaceuticals, natural medicines, quasi-pharmaceuticals, health products, and cosmetics into Indonesia.

Standards for imported pharmaceuticals that do not require a distribution license

• For personal use;

• Research;

• Product and/or scientific development;

• Donation;

• Samples used for distribution license registration;

• Clinical trials.