If my company's main business is medical devices, but some products (such as medicated patches) are classified as medicines, do I need to apply for a pharmaceutical licence for the entire company?

Yes, you need to apply for the appropriate pharmaceutical licence for the part of your business that handles products classified as medicines. Hong Kong regulates medicines and medical devices separately, through the Department of Health's Drug Office and Medical Device Division respectively. If one of your products—for example, an analgesic patch containing a western medicine ingredient—is classified as a “pharmaceutical product” based on its ingredients, mode of action or claimed therapeutic effects, any import, wholesale, retail or manufacturing activities involving it must be conducted under the relevant pharmaceutical licence. Your main business being medical devices does not exempt you from the licensing requirements for your medicine business. The company must establish a separate area that complies with Good Distribution Practice (GDP) for storing and handling these medicines, and appoint a qualified RP.