Getting a US-approved medicine in Hong Kong: the legal route, documents and timing

Creator: Reserve Meds
Published: 2026-10-17

A sourced guide for patients, families and doctors in Hong Kong, checked against Department of Health 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 Hong Kong, a registered medical practitioner or dentist may use an unregistered drug to treat a particular patient when no registered drug is effective. The import needs a Department of Health import licence, applied for online, with a performance pledge of two working days. The Hospital Authority also runs a Named Patient Programme.

Regulator: Pharmacy and Poisons Board and the Department of Health (Drug Office).
Main route: Unregistered drug for a particular patient, imported under a Department of Health import licence.
Who acts: A registered doctor or dentist, with a licensed dealer as importer.
Price: Quote on request.

Who regulates medicines in Hong Kong

Under the Pharmacy and Poisons Regulations (Cap. 138A), pharmaceutical products must be registered with the Pharmacy and Poisons Board of Hong Kong before they can be sold or supplied.^[1]

The legal route for a medicine that is not registered in Hong Kong

For life-threatening and severely debilitating diseases, the law allows a registered medical practitioner or registered dentist to possess or use an unregistered drug to treat a particular patient when no registered drug is available for effective treatment.^[1]

Importing such a drug needs an import licence from the Department of Health, issued under the authority of the Director-General of Trade and Industry under the Import and Export Ordinance (Cap. 60). A company must hold an appropriate dealer's licence from the Pharmacy and Poisons Board before it can apply. Since 31 December 2021, applications are accepted only online through the Pharmaceutical Licence Application and Movement Monitoring System (PLAMMS).^{[1, 2]}

Public hospital patients may be served through the Hospital Authority's Named Patient Programme. In a December 2024 Legislative Council question, members raised concerns about full prepayment and lead times under that programme; the government encourages suppliers to register drugs with continued need.^[1]

Documents you will usually need

The WTO import licensing notification says the application covers particulars of the importer, the import and the products, plus the dealer's licence. Our checklist:^[2]

The treating doctor's prescription and clinical justification for the particular patient
Particulars of the importer (a licensed dealer), of the import and of the product, as required on the import licence application
A copy of the importer's valid dealer's licence from the Pharmacy and Poisons Board
Evidence of the medicine's approval abroad, such as the US FDA approval and label

Timing, quantities and fees

The Drug Office's performance pledge for approving import and export licences for pharmaceutical products is two working days.

How a US-approved medicine reaches a patient in Hong Kong

First, confirm the medicine is approved in the US. FDA's Drugs@FDA database lists approved prescription medicines and links to the approved label.^[3]

In Hong Kong the treating doctor decides on the unregistered drug and a licensed dealer applies for the import licence. We work with the doctor and the importing dealer and ship from the US through our wholesale partner once the licence is issued.

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.^[4]

Practical checks before you start

Ask the treating specialist whether a registered alternative already exists in Hong Kong. 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 Hong Kong

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

Can a doctor in Hong Kong use a drug that is not registered there?

Yes, for a particular patient with a life-threatening or severely debilitating disease, when no registered drug is effective. The import needs a Department of Health import licence.

How fast is the Hong Kong import licence?

The Drug Office's performance pledge is two working days for import and export licences for pharmaceutical products.

Who can apply for the import licence?

A company holding an appropriate dealer's licence from the Pharmacy and Poisons Board, applying online through PLAMMS.

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, 2]}

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.

Hong Kong SAR Government: LCQ8, Introduction of drugs for use in Hong Kong (11 December 2024) (accessed 17 October 2026)
WTO Import Licensing: Hong Kong, China, pharmaceutical products and medicines (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)

This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.