Is there a specific minimum area requirement for business premises when applying for a pharmaceutical wholesale dealer licence in Hong Kong?

When assessing applications for pharmaceutical wholesale dealer licences, the Drug Office, Department of Health, does not prescribe a minimum floor area for business premises in the regulations. This does not mean, however, that any floor area will suffice. The key principle is that “the area of the premises must be appropriate to the scale of the business and the types of medicines handled”. Inspectors will assess a range of factors, including the quantity and types of medicines you plan to store and handle, their storage requirements (such as ambient temperature or refrigeration), and whether processing or packaging will be required. If a space is too small to meet functional zoning requirements—for example, if it has no separate quarantine area pending examination, released-goods area, returns area or office—or if medicines are stored in a disorderly manner with a high risk of cross-contamination, the licence application is very likely to be refused. The floor area should therefore be sufficient to clearly separate each functional area and ensure the safe, orderly storage and handling of medicines.