By: Muhammad Haryadi & Alda Humaira
Bringing personal medicines obtained from foreign country is a topic that revolves around the practice of individuals bringing medications for personal use into their home country. In various situations, individuals may find themselves in need of specific medications that are not readily available or accessible in their home country. This could be caused by the unavailability of the medication locally, cost considerations, or the need for a specific brand or formulation that is only found in foreign country. However, bringing personal medicines obtained from foreign country is subject to various legal, regulatory, and safety considerations in Indonesia.
B. Necessity of Distribution Permit for Personal Use Medicines
According to the Indonesian Food and Medicines Supervisory Agency Regulation Number 30 of 2017 regarding the Supervision of the Entry of Medicines and Food into the Territory of Indonesia, as amended by the Indonesian Food and Medicines Supervisory Agency Regulation Number 15 of 2020 regarding Amendments to the Indonesian Food and Medicines Supervisory Agency Regulation Number 30 of 2017 regarding the Supervision of the Entry of Medicines and Food into the Territory of Indonesia (“PBPOM 15/2020”), all medicines that enter Indonesia with the intention of distribution shall have a distribution permit (izin edar) as approval over the registration of medicines and food issued by the Head of Indonesian Food and Medicines Supervisory Agency (“Head of BPOM”) to be distributed in Indonesia. However, this regulation provides the following exceptions for:
- Personal use based on the consideration of healthcare workers or without the consideration of healthcare workers;
- Product and/or knowledge development;
- Samples for registration of distribution permit;
- Clinical trials for registration requirements, product and/or knowledge development;
- Government programs;
- Urgent national interests;
- Special use for healthcare services that cannot be produced domestically; and
Bringing medicines and food into the territory of Indonesia for personal use, research, product development, scientific purposes (research), samples for registration, and/or exhibitions as referred to above shall meet the following requirements:
- Not intended for commercial purposes; and
- In limited quantities according to the needs.
In light of the above, it is clear that all medicines intended for personal use that are obtained by an individual from a foreign country do not require to obtain the distribution permit issued by the Head of BPOM.
C. Inspections by Customs Officials
Referring to the Minister of Finance Regulation Number 203/PMK.04/2017 of 2017 regarding Provisions on the Export and Import of Goods Carried by Passengers and Transportation Crew (“MOF Regulation 203/2017”), customs officials (pejabat bea dan cukai) are employees of the Directorate General of Customs and Excise that are appointed in certain positions to perform certain duties based on the customs law. Customs officials are also authorized to conduct physical inspections of imported goods such as medicines carried by passengers and transportation crew, then inspections will be performed through the red line (jalur merah). The red line itself is a standard clearance and monitoring process to examine the imported goods by the customs officials, involving physical inspections and document research from the importer. Further, the goods that are categorized as red line has been specifically regulated in MOF Regulation 203/2017.
In the event that the imported goods are not categorized as red line, then the customs officials will conduct a physical inspection of imported goods through the green line (jalur hijau). The green line itself is a clearance process by customs officials to examine and determine whether the imported goods have been in accordance with applicable customs regulations without the requirement of a physical inspection.
On the other hand, the entry of medicines and food into the territory of Indonesia for personal use will be performed through a special access scheme (“SAS” or mekanisme jalur khusus). SAS is a special way of mechanism to bring medicines that do not have distribution permit but are highly necessary under specific conditions into the territory of Indonesia, including for the purpose of personal use based on healthcare workers’ considerations.
According to the Indonesian Food and Medicines Supervisory Agency Regulation Number 30 of 2022 regarding the Entry of Medicines and Medicinal Ingredients through Special Access Scheme (SAS) Mechanism (“PBPOM 30/2022”), it is stipulated that bringing medicines and medicinal ingredients through SAS shall obtain prior approval from the Head of BPOM or Minister of Health. Therefore, in order to obtain the SAS approval, the applicants shall complete the following steps:
- Accessing the relevant website through e-bpom.pom.go.id and register to obtain a valid account;
- Having an online single submission account for applicants in the field of pharmaceutical industry, contract research organization and pharmaceutical wholesale; and
- Submitting the required documents:
- Letter of Application;
- Statement Letter (duty stamped);
- Product Information;
- Manufacturer’s Good Manufacturing Process (GMP) Certificate;
- Statement letter regarding Cold Chain Management facilities; and
However, there are also exceptions to obtain SAS approval under PBPOM 30/2022 for the following criteria:
- Medicines and medicinal ingredients in the form of narcotics, psychotropics, and pharmaceutical precursors; and
- for personal use.
Essentially, it is not necessary for the personal used medicine to obtain the SAS approval. However, prior to the arrival at the Indonesian Customs and Excise at the airport, the person who bring the medicines shall prepare several documents related to the medicines as follows:
- Formal letter from the doctor explaining the content, dosage, and prescription of the medicines, as well as their intended use in Indonesia; and
- Name on the doctor’s letter/prescription shall match with the name of person who bring the medicines as stated in the boarding pass.
Upon arrival at the Indonesian Customs and Excise at the airport, the person who bring the medicines are required to report the personal medicines and fill in a template form as regulated in Annex III of PBPOM 15/2020.
In connection with the above, any medicines for personal use entering the territory of Indonesia are also subject to the tax regulations. Therefore, it is necessary to conduct a consultation or further research for these tax regulations depending on the types of such personal medicines.
As discussed above, all medicines obtained from foreign country to enter the territory of Indonesia shall have a distribution permit, except for medicines that meet the requirements regulated under PBPOM 15/2020 and PBPOM 30/2022, including the medicines intended for personal use or consumption (not for sale or distribution). Furthermore, the person who bring such medicines shall prepare the required documents and will have several stages of reporting and inspection for their personal medications through SAS by the custom officials. This process is intended to ensure compliance with the applicable laws and regulations in Indonesia as well as the safety of the medication’s usage.
Disclaimer: This article is limited to personal use medicines and does not include all possible objects/goods. Please note that different objects may be subject to different treatment, rules and regulations depending on their nature.
 Consular Office of the Republic of Indonesia in the United States of America, “Bringing Medicines to Indonesia.” https://consular.embassyofindonesia.org/page/wnifaq.html.