Q229 · Will the application requirements be relaxed…

Q229 · 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

Neither the Pharmacy and Poisons Ordinance nor the Code of Practice for Wholesale Dealers establishes different licence grades or application requirements for medicines with different risk levels. All applicants must meet the same GSDP (Good Storage and Distribution Practice) standard.

📗 Drew Tang's recommendations

Although the application standards are not reduced, we can design a more cost-effective compliance solution to suit your simple business model. For example, your premises may be relatively small and your SOP processes may be relatively straightforward, such as not involving complex recall or complaint-handling procedures. We will help you find the most economical operating model while remaining fully compliant, avoiding over-engineering and matching your initial investment to the scale of your business.

📕 Risk notice

The risk lies in the mistaken expectation that “requirements will be relaxed”, leading to carelessness in preparation. For example, you might assume that a low-risk product means you can simply rent an office as a warehouse, or let a company administrator double as the person responsible. This would put you on the wrong track from the very first step of the application, wasting considerable time and resources.

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.

Will the application requirements be relaxed if I only plan to wholesale one very low-risk over-the-counter (OTC) medicine?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang