Can an overseas pharmaceutical company apply directly for a Hong Kong pharmaceutical licence, or must it first establish a Hong Kong company?

This is a crucial question: determining whether your product is “food” or “medicine” is the first step. In Hong Kong, if your product meets the definition of a “proprietary Chinese medicine” under the Chinese Medicine Ordinance—that is, its active ingredients consist solely of Chinese herbal medicines and it is intended to diagnose, treat or prevent disease or regulate the functions of the human body—you need to apply for a Manufacturer of Proprietary Chinese Medicines Licence and comply with the GMP requirements for proprietary Chinese medicines. If the ingredients are not regarded as Chinese herbal medicines, or the health claims made do not involve therapeutic effects, the product may be classified as “food” or “health food” and regulated by the Centre for Food Safety (CFS), without requiring a pharmaceutical licence. However, the dividing line may be unclear.