Q174 · Will it adversely affect my licence…

Q174 · Category D: Premises and Storage Requirements (Q151-Q200)

The surrounding environment of a warehouse is one of the factors the Department of Health may consider when assessing an application. If your medicine warehouse is next to a restaurant, food-processing plant, refuse treatment facility or other premises that may be a serious source of pests, odours or contamination, this may negatively affect the licence application. The regulatory authority’s main concern is that these neighbouring activities may significantly increase the risk of your premises attracting and harbouring pests (such as cockroaches and rats). Even if your internal pest control is effective, pressure from the external environment may make the problem unmanageable. In addition, strong odours (such as cooking fumes) may enter the warehouse through the ventilation system, doors or windows and contaminate medicine packaging or even the contents. You will therefore need to demonstrate to the Department of Health that you have additional, highly effective measures to guard against these external risks.

📘 Regulatory basis

Good Distribution Practice (GDP) requires premises to be situated in a suitable environment and away from sources of contamination that could adversely affect the quality of medicines. Inspectors have the right to assess environmental risks around the premises.

📗 Drew Tang's recommendations

At the site-selection stage, we strongly recommend that clients thoroughly investigate the surroundings of the premises under consideration. If you cannot avoid being next to a high-risk neighbour, you must invest more in physical controls, such as improving the seals on all doors and windows, installing double doors or air curtains, and arranging a more frequent and comprehensive monitoring and treatment plan with a pest control company. It is essential to clearly set out these additional risk-control measures in the application documents.

📕 Risk notice

Do not underestimate the effect of the surrounding environment. If you choose premises above which there is a seafood market as a medicine warehouse, your chances of obtaining a licence may be negligible, regardless of your efforts inside. The regulatory authority may consider pest and hygiene risks in such an environment to be uncontrollable. A poor choice of location could render all your subsequent investment futile.

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 it adversely affect my licence application if the warehouse I have selected is next to a restaurant or food processing factory?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang