Q86 · What is a “Named Patient Program”? How can…

Q86 · Category B: Licence types and scope of application (Q51-Q100)

The Named Patient Program (NPP), sometimes also known as “compassionate use”, is a special medicine supply mechanism. It allows a registered doctor in Hong Kong to apply to use, for a specific patient under their care, a medicine that is not yet registered in Hong Kong but is already marketed in another country and has significant therapeutic benefits. Licensed wholesalers play a key role in importing and distributing the medicine. The usual process is as follows: a doctor submits an application to the Department of Health for a patient. After approval, the doctor engages a licensed wholesaler to use the one-off special permit to import a specified quantity of the unregistered medicine from overseas and supply it directly to the doctor for treating that named patient.

📘 Regulatory basis

Section 36 of the Pharmacy and Poisons Regulations allows medicines to be exempted from registration requirements in certain circumstances, and NPP is based on this provision. The process requires close coordination between doctors, wholesale dealers and the Department of Health, together with stringent documentation requirements.

📗 Drew Tang's recommendations

For wholesalers, participating in NPP projects is not merely a business activity but also an opportunity to demonstrate professional competence and social responsibility. To operate NPP successfully, RGYS may assist with organising roles, qualification evidence and responsibility arrangements within the written scope; candidate suitability, appointment and actual attendance in the role must still be verified by the applicant and legally qualified personnel. No provision of personnel or certification is promised. We will assist you in establishing SOPs specifically for handling NPP orders, ensuring accuracy at every stage from application and import to delivery.

📕 Risk notice

Medicines supplied under the NPP are not locally registered, so the chain of ownership and responsibility for their use must be very clear. The medicines may and must be supplied directly only to the applying doctor; they must never be diverted for another use or sold to anyone else. Any discrepancy in quantity or incorrect distribution will be treated as a serious breach and undermine the foundation of trust in the entire special approval mechanism.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

What is a “Named Patient Program”? How can licensed wholesalers participate?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang