Can Imported Drugs Be Sold Without a Distribution Licence?

The Question Our company plans to procure an antidote to treat a type of poisoning (caused by a harmful substance produced during a mining process) that cannot be sold in Indonesia. This drug can only be bought from abroad, but it has no distribution licence in Indonesia. One supplier (PT ABC) says it can provide or import the drug, but the company does not hold a distribution licence and is neither an official distributor nor an agent. Given how important this drug is to our company, may we purchase the antidote through PT ABC without a distribution licence? All import permits and customs clearance would be handled by PT ABC, after which our company would buy the antidote. Summary Answer Before answering your question, we assume that the antidote you refer to is a 'drug', defined as follows: A drug is a substance or combination of substances used to affect or study a physiological system or pathological condition, including biological products, for the purposes of diagnosis, prevention, treatment, rehabilitation, health promotion and contraception. Based on this definition, we assume that the drug you refer to is intended for human use. In addition, based on the information you provided, the antidote you use must be imported, because it is not produced in Indonesia. Under Article 2 of BPOM Regulation No. 27/2022, drugs and food imported into Indonesia for distribution must hold a distribution licence and comply with the relevant laws. Moreover, drugs may only be imported by the holder of a distribution licence or its agent. A holder of a drug distribution licence may authorise another pharmaceutical company, an importer of pharmaceutical products, or a government agency to import drugs. A distribution licence is the form of approval for the registration of drugs, traditional medicines, quasi-drugs, health supplements and processed food, or the notification of approval for cosmetics and the fulfilment of commitments for processed food, allowing distribution in Indonesia. In addition to holding a distribution licence and complying with the relevant regulations, the import of drugs must also obtain the approval of the Head of BPOM, in the following form: An Import Border Certificate (SKI) for importing drugs, traditional medicines, quasi-drugs, health supplements and cosmetics; or An Import Border Certificate (SKI Post Border) for importing processed food. Given our assumption that the antidote you mention falls within the category of 'drugs', for simplicity its import must obtain an Import Border Certificate (SKI). What is an Import Border Certificate (SKI)? An SKI is an approval letter for importing goods into Indonesian territory, which must be obtained before the goods leave the customs area, so that the distribution of drugs and food can be supervised. This SKI is valid for a single entry only and must be obtained at the same time as the import application is submitted to the authorised body. So who needs to apply for an SKI? Companies holding a distribution licence, government agencies, and importers authorised by a distribution-licence holder may all apply for a Border SKI (special import permit) to import drugs, traditional medicines, quasi-drugs, health supplements and cosmetics into Indonesia. Based on the information you provided, PT ABC must obtain a distribution licence, or itself be a company holding a distribution licence, because it would act as an agent distributing the drug to your company. Criteria for Imported Drugs That Do Not Require a Distribution Licence However, we should inform you that in certain situations, drugs that have not yet obtained a distribution licence may also be imported into Indonesia. These specific uses include: Personal use Research Product and/or scientific development Donation Samples for distribution-licence registration Clinical trials