Hong Kong Drug Licence Applications and Acquisitions · RGYS|Global Licensing and Compliance Service Provider
Hong Kong pharmaceutical compliance · applications / acquisitions / ongoing maintenance Independent Third-Party Service Provider
HONG KONG DRUG LICENSING

Can I start some business activities while waiting for my licence application to be approved, such as marketing or signing letters of intent with customers?

A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.

Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.

Drug Office, Department of Health Chinese Medicines Board

Q226 · Category E: Application Process and Approval Procedures (Q201-Q250)
This is a matter where the boundary must be absolutely clear. Before you formally obtain a pharmaceutical licence issued by the PPB, you must not carry out any business activity within the scope of the licence. Specifically, you must not import, export, wholesale, sell, distribute or store any pharmaceutical products. Any of these activities would constitute operating without a licence, which is a serious criminal offence. However, preparatory business activities that do not involve actual transactions in pharmaceutical products are permitted. For example, you may conduct market research, design your company website (but not sell pharmaceutical products online), make initial contact with potential suppliers or customers, discuss a framework for cooperation, or even sign a non-legally binding letter of intent (LOI) or memorandum of understanding (MOU), provided that the documents clearly state that all cooperation can only proceed once you have formally obtained the licence.

📘 Regulatory basis

Section 29 of the Pharmacy and Poisons Ordinance expressly provides that no person may sell or distribute any poison unless they are an authorised seller. The penalties for operating without a licence are severe and include substantial fines and imprisonment.

📗 Drew Tang's recommendations

We recommend that clients use the waiting period to focus on “strengthening internal capabilities”, for example by improving internal SOPs, providing staff with GSDP training, and establishing customer and supplier files. During commercial negotiations with external parties, we will review letters of intent or draft contracts to ensure that the terms clearly link the start of the actual transaction to the licence grant date, helping you mitigate legal risks.

📕 Risk notice

The greatest risk is “jumping the gun”. Some applicants, in an attempt to gain a foothold in the market, may accept orders or even import small quantities of goods before obtaining a licence. If the Department of Health discovers this, whether following a complaint or a Customs spot check, your licence application may be suspended and refused immediately, and the company and its directors may also face criminal prosecution, with potentially devastating consequences for the business. Do not break the law.

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