Q121 · What should we do if the nominated…

Q121 · Category C: Applicant eligibility and personnel requirements (Q101–Q150)

This is a common but complex issue. Under Hong Kong law, a valid prescription must be issued by a doctor, dentist or veterinary surgeon registered in Hong Kong. Strictly speaking, therefore, a pharmacy / Authorised Seller of Poisons (ASP) in Hong Kong cannot lawfully dispense prescription medicines on the basis of a prescription issued by an overseas doctor, such as one from Mainland China, the United States or the United Kingdom. Even if the doctor is qualified to practise in their own country, a prescription signed by them has no legal effect in Hong Kong because they are not registered with the Medical Council of Hong Kong. A pharmacy that dispenses medicines on this basis would incur legal risks.

📘 Regulatory basis

One of the basic requirements for a licence application is the appointment of qualified key personnel. Although the Ordinance does not specify a procedure for personnel changes during the application period, under the principle of ongoing compliance any significant change affecting licensing conditions must be notified immediately.

📗 Drew Tang's recommendations

In this situation, speed is critical. RGYS may assist with clarifying roles, evidence of qualifications and responsibility arrangements within the written scope; the suitability, appointment and actual presence at work of candidates remain subject to verification by the applicant and legally qualified personnel, and no provision or certification of personnel is promised. We will promptly initiate the recruitment process for a new RP. At the same time, we will assist the client in drafting a formal notification letter to the Drug Office and preparing a complete set of application materials for the new nominee, seeking to minimise delays.

📕 Risk notice

Concealing the departure of an RP, or continuing with an application without a qualified RP, is absolutely inadvisable. The regulatory authority may contact the RP at any time during its review. If the information is found to be inconsistent, the application will be regarded as containing a false statement and is very likely to be rejected outright, seriously damaging the company's credibility.

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 should we do if the nominated Responsible Person (RP) suddenly leaves while the company’s licence application is being processed?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang