Following is a question by the Hon Ginny Man and a reply by the Secretary for Health, Professor Lo Chung-mau, in the Legislative Council today (October 21):
 
Question:
 
     It is learnt that many members of the public would purchase over-the-counter medicines while travelling abroad for personal use in Hong Kong. Some of these medicines are controlled drugs, such as poisons included in Part I of the Poisons List under the Pharmacy and Poisons Regulations, and taking them without the guidance of a healthcare professional may pose a risk to health. In this connection, will the Government inform this Council:
 
(1) given that, according to the website of the Drug Office of the Department of Health, pharmaceutical products imported in the accompanied personal baggage of a person entering Hong Kong for his or her personal use and in reasonable quantity may be exempted from licensing requirement, of the definition of "reasonable quantity";
 
(2) of the number of prosecutions instituted by the Government over the past three years in respect of the illegal sale of unregistered pharmaceutical products; and
 
(3) given that the Poisons Committee will advise the Hong Kong Pharmacy and Poisons Board of Hong Kong on the review of the classification of regulated pharmaceutical products, of the specific details of the review (including the mechanism for substances and drugs to be added to or removed from the Poisons List, as well as the review cycle for the Poisons List)?
 
Reply:
 
President,

     The Government has in place a stringent regulatory regime for medicines with a view to safeguarding public health. Any product which falls within the definition of "medicine" under the Pharmacy and Poisons Ordinance (Cap. 138) (i.e. "pharmaceutical product") must be approved for registration by the Pharmacy and Poisons Board of Hong Kong (the Board) before it can be sold in Hong Kong.
 
     The term "poisons" mentioned in the question is a term used under Cap. 138, which refers to the regulated western medicine chemical ingredients contained in pharmaceutical products with potential side effects and is different from the general public's everyday understanding of "poisons" or "drugs" as substances that cause harm to people. Under the statutory framework, substances defined as poisons are specified in Schedule 10 to the Pharmacy and Poisons Regulations (Cap. 138A) (the "Poisons List") and are classified under different parts of the Poisons List and other Schedules to Cap. 138A according to their efficacy and potential side effects. The extent of control over individual pharmaceutical products depends on the classes of poisons they contain, and such products can mainly be divided into five major categories.
 
     The first category is "prescription drugs". Such pharmaceutical products (e.g. antihypertensive drugs) require a prescription from a registered medical practitioner, registered dentist or registered veterinary surgeon, and may only be dispensed in accordance with the prescription at authorised sellers of poisons (commonly known as pharmacies) under the supervision of registered pharmacists.
 
     The second category covers pharmaceutical products which may be sold without a prescription but only at pharmacies under the supervision of registered pharmacists (e.g. cough syrups containing less than 0.2 per cent codeine). Registered pharmacies and pharmacists are required to keep, for each sale, a sales record in the specified format for inspection by the Department of Health (DH).
 
     The third category is similar to the second category in that such products must also be sold at pharmacies under the supervision of registered pharmacists, but there is no requirement to keep sales records in the specified format. Examples include anti-inflammatory and analgesic medicines such as ibuprofen.
 
     The fourth and fifth categories are collectively known as "over-the-counter medicines". The fourth category refers to pharmaceutical products containing Part 2 poisons of the Poisons List (e.g. analgesic and antipyretic medicines such as paracetamol, and chlorpheniramine contained in common cold and flu medicines), which may be sold not only at pharmacies but also at listed sellers of poisons (commonly known as drug stores, such as the common convenience stores); whereas the fifth category covers pharmaceutical products whose ingredients do not include any substance on the Poisons List (e.g. certain mucolytics), which may be sold at general retail outlets.
 
     Having consulted the Customs and Excise Department (C&ED) and the DH, our consolidated reply to the various parts of the question raised by the Hon Ginny Man is as follows:
 
(1) and (2) Under Cap. 138, any person who illegally sells or possesses unregistered pharmaceutical products or Part 1 poisons of the Poisons List in Hong Kong commits an offence and shall be liable, upon conviction, to a maximum penalty of a fine of $100,000 and imprisonment for two years. The import and export of pharmaceutical products are also regulated under the Import and Export Ordinance (Cap. 60), under which every importation must be covered by a licence issued by the DH under the authority of the Director-General of Trade and Industry. Any person who imports or exports pharmaceutical products without a licence commits an offence and shall be liable, upon conviction, to a maximum penalty of a fine of $500,000 and imprisonment for two years.
 
     Having regard to the practical needs of members of the public and travellers to use pharmaceutical products for their own health conditions, the Import and Export (General) Regulations (Cap. 60A) provide for the relevant exemption. An inbound traveller is exempted from applying for an import licence for carrying in his or her accompanied baggage a reasonable quantity of pharmaceutical products for personal use. C&ED officers will make an overall assessment, on a case-by-case basis, of whether the quantity is reasonable for personal use, taking into account the individual circumstances, the relevant information provided and the product packaging, and will consult DH where necessary. If the pharmaceutical products concerned are classified as dangerous drugs under the Dangerous Drugs Ordinance (Cap. 134), antibiotics under the Antibiotics Ordinance (Cap. 137) or Part 1 poisons under Cap. 138, a doctor's prescription is required for carrying them across the boundary.
      
     The Government has all along been rigorously combating the illegal importation or sale of unregistered pharmaceutical products. Over the past three years, C&ED has detected 1 043 cases involving suspected illegally imported pharmaceutical products, with the articles seized valued at about $364 million, and prosecution has been instituted in respect of 140 of these cases.

     DH has also been monitoring pharmaceutical products sold online and in the market and taking active enforcement action. From January 2023 to September 2026, a period of over three years, DH handled 108 conviction cases involving the sale and/or possession of unregistered pharmaceutical products, with the maximum penalty imposed being 10 months' imprisonment or a fine of $242,000.
 
(3) Pharmaceutical products are classified in accordance with risk level based on professional assessment. The Poisons Committee (the Committee) under the Board, with experts taking part in the assessment, keeps under continuous review the classification and distribution of various poisons on the Poisons List and provides professional advice to the Board. If the review results indicate the need to adjust the classification of substances on the Poisons List, the Government will amend Cap. 138A through the negative vetting procedure to ensure that regulation keeps pace with the times. From 2025 to September 2026, new substances were added to the Poisons List and the relevant Schedules in respect of 68 new drug registration applications, and the classification of one drug on the Poisons List and the relevant Schedules was revised by the Committee in the light of its safety information.
 
     Thank you, President.

Ends/Wednesday, October 21, 2026
Issued at HKT 14:28

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