Caution and Legal Requirements for Importing Medicines into Hong Kong

Regulatory Advisory on Importing Medicines to Hong Kong

Engaging in the importation of pharmaceutical products to Hong Kong, whether for personal consumption or commercial distribution, is subject to stringent regulatory control under the Pharmacy and Poisons Ordinance (Cap. 138) and the Import and Export Ordinance (Cap. 60). Individuals must exercise extreme caution when procuring medicines from overseas.

Risks of Unregistered Products

Products purchased from overseas sources that are not officially registered with the Pharmacy and Poisons Board of Hong Kong (the Board) pose significant health risks. Their safety, quality, and efficacy are not guaranteed by the regulatory body. Individuals are strongly advised to avoid purchasing medicines from doubtful or unverified international suppliers.

Importation for Personal Use

The importation of pharmaceutical products is controlled and typically requires a license issued by the Department of Health. However, a limited exemption exists:

Exemption: Pharmaceutical products carried in the accompanied personal baggage of a person entering Hong Kong, which are intended strictly for that person's personal use and are in a reasonable quantity, may be exempt from the licensing requirement.

Warning: Despite this exemption, the underlying legal requirement for registration still applies to products sold in Hong Kong, and purchasing unregistered medicines carries inherent risks to health.

Importation and Sale for Commercial Purposes

The commercial sale, supply, or distribution of pharmaceutical products in Hong Kong—including sales conducted via the Internet—is strictly prohibited unless the product has been officially registered with the Board.

Legal Mandate: All pharmaceutical products intended for sale must be registered prior to market entry.

Penalties: The illegal sale of unregistered medicines is a criminal offence. Upon conviction, the maximum penalty is a fine at level 6 (HK$100,000) and imprisonment for two years. Furthermore, even registered products may be subject to different levels of control, requiring specific licences or authorisation for handling and sale.

Legal Definition

Under the Pharmacy and Poisons Ordinance, a “pharmaceutical product” or “medicine” is defined as a substance or combination of substances that:

Is presented as having properties for treating or preventing disease in humans or animals; or

May be used in or administered to humans or animals with a view to restoring, correcting, or modifying physiological functions by pharmacological, immunological, or metabolic action, or for making a medical diagnosis. This definition also includes advanced therapy products.