Getting a US-approved medicine in Indonesia: the legal route, documents and timing
A sourced guide for patients, families and doctors in Indonesia, checked against Ministry of Health and BPOM rules on 17 October 2026.
Reviewed by the Reserve Meds clinical operations team on 17 October 2026. Sources accessed 17 October 2026.
The short answer
In Indonesia, medicines without a marketing authorization (izin edar) can be brought in through the Special Access Scheme (SAS) when they are urgently needed or not produced or not sufficient locally. The Ministry of Health approves SAS for most medicines; BPOM approves SAS for biological products. Quantities must be limited and not commercial.
- Regulators: Ministry of Health (Ditjen Farmalkes) and the Food and Drug Authority (BPOM).
- Main route: Special Access Scheme (SAS), jalur khusus.
- Who applies: Healthcare service providers and authorised importers for patient care.
- Price: Quote on request.
Who regulates medicines in Indonesia
Indonesia splits authority for SAS approvals under Government Regulation 5 of 2021. SAS for medicines other than biologics, for health services, donations and government programmes, is approved by the Ministry of Health under Minister of Health Regulation 14 of 2021. SAS for biological products, research and pharmaceutical raw materials is approved by BPOM under BPOM Regulation 30 of 2022.[1]
The legal route for a medicine that is not registered in Indonesia
The Ministry of Health describes SAS as the entry of medicines that do not yet have a marketing authorization but are urgently needed, or are not yet produced in Indonesia, or are produced but not in sufficient quantity for health services.[1]
Medicines entering through SAS must meet safety, efficacy and quality standards, come from an official source, not be for regular needs, be in a limited quantity matching the need, and not be for commercial purposes.[1]
In June 2024 the Ministry introduced SiDiLaS, a digital service system to speed up SAS licensing.[1]
Documents you will usually need
The Ministry's announcement sets criteria rather than a document list. Our checklist for showing the criteria are met (the agency may ask for more):[1]
- The requesting health facility's justification of need for the patient or patients
- Evidence that the product meets safety, efficacy and quality standards, such as approval by the US FDA and the label
- Evidence that it comes from an official source (supply chain documents)
- The limited quantity requested and the intended use
Timing, quantities and fees
The Ministry's announcement does not state a fixed SAS processing time; SiDiLaS was introduced to speed it up. For biologics the BPOM route applies.[1]
How a US-approved medicine reaches a patient in Indonesia
First, confirm the medicine is approved in the US. FDA's Drugs@FDA database lists approved prescription medicines and links to the approved label.[2]
In Indonesia, the hospital or an authorised importer requests SAS approval from the Ministry of Health, or from BPOM for a biologic. We supply the official-source and approval documents and ship from the US through our wholesale partner once approval is in place.
Once the local permission is in place, the medicine is bought from the US supply chain, packed for the temperature the label requires, and shipped to the named hospital, clinic or importer with the documents customs will ask for. Cold-chain medicines need a validated shipper and a temperature record for the whole journey.
If the medicine is a cell or gene therapy, the rules are different: these are usually given only at qualified treatment centers chosen by the manufacturer, so the realistic route is often treatment at a center abroad rather than import.[3]
Practical checks before you start
- Ask the treating specialist whether a registered alternative already exists in Indonesia. Most special routes only apply when it does not.
- Check whether the medicine is a controlled drug. Controlled medicines need extra permits in almost every country.
- Ask the hospital pharmacy whether it has handled this route before and who signs the application.
- Keep copies of every document and approval. Customs and the hospital will ask for them again at delivery.
How Reserve Meds helps
Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help families and treating doctors understand the route, prepare the documents the regulator or hospital asks for, arrange supply from the US once approval is in place, and keep everyone updated. We do not diagnose, prescribe or decide what a regulator approves.
We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them. Your coordination fee is quoted in writing for your case before you commit. No hidden charges. We give you a written timeline estimate for your case before you commit.
Ask us about a medicine for a patient in Indonesia
Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.
Frequently asked questions
What is the Special Access Scheme in Indonesia?
A special route for medicines without an Indonesian marketing authorization that are urgently needed or not available in sufficient quantity, approved by the Ministry of Health or, for biologics, by BPOM.
Who approves SAS for a biologic medicine?
BPOM, under BPOM Regulation 30 of 2022. Other medicines for health services are approved by the Ministry of Health.
Can SAS be used to stock a medicine commercially?
No. SAS medicines must be in limited quantities, not for regular needs and not for commercial purposes.
Does Reserve Meds apply to the regulator for us?
No. The application is made by the person or institution the rules name, usually the treating doctor or hospital. We help prepare the paperwork, confirm the US approval and arrange supply from the US once permission is granted.
How much does it cost?
Quote on request. The total depends on the medicine, the dose, shipping, import steps and coordination. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.
Sources for these answers: [1]
Sources
All sources were opened and checked on 17 October 2026. Rules and labels change, so the treating hospital or regulator confirms the current position before anything is filed.
- Ministry of Health Indonesia (Ditjen Farmalkes): Special Access Scheme (SAS) and SiDiLaS, 26 June 2024 (accessed 17 October 2026)
- US FDA: How do I find out if a drug is approved? (accessed 17 October 2026)
- US FDA: Approved Cellular and Gene Therapy Products (accessed 17 October 2026)
Related
- All country guides
- Named-patient access, explained
- US expanded access (compassionate use)
- Answers to common access questions
- How cold-chain medicines are shipped
This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.