What Changed
- Detailed the five-tier classification system for pharmaceutical products under Cap. 138 and Cap. 138A.
- Clarified C&ED case-by-case criteria for the personal baggage import licence exemption under Cap. 60A.
- Released enforcement metrics from C&ED and DH covering prosecutions, convictions, and product seizures from 2023 to September 2026.
In a written reply to Legislative Council Question 5 (LCQ5) on October 21, 2026, the Secretary for Health of Hong Kong SAR, Professor Lo Chung-mau, provided detailed clarifications regarding the statutory regulation of medicines, import licensing exemptions for personal baggage, enforcement actions, and the classification review process for regulated substances. The response followed inquiries raised by Legislative Council Member Hon Ginny Man concerning over-the-counter medicines purchased abroad by members of the public for personal use in Hong Kong.
### Statutory Framework and Classification of Medicines
Under Hong Kong's legal framework, pharmaceutical products are governed principally by the Pharmacy and Poisons Ordinance (Cap. 138) and its subsidiary legislation, the Pharmacy and Poisons Regulations (Cap. 138A). Any product meeting the statutory definition of a "pharmaceutical product" or "medicine" under Cap. 138 must receive registration approval from the Pharmacy and Poisons Board of Hong Kong (the Board) prior to commercial sale within the Special Administrative Region.
The statutory term "poisons" under Cap. 138 specifically designates regulated western medicine chemical ingredients with potential side effects, listed under Schedule 10 to Cap. 138A (the "Poisons List"). Based on efficacy, safety profiles, and potential side effects, pharmaceutical products are categorized into five main regulatory groups:
1. **Prescription Drugs:** Products such as antihypertensive medications require a formal prescription from a registered medical practitioner, registered dentist, or registered veterinary surgeon. These must be dispensed exclusively at authorised sellers of poisons (pharmacies) under the direct supervision of a registered pharmacist.
2. **Controlled Non-Prescription Drugs with Sales Records:** Products that do not require a prescription but must be sold at pharmacies under registered pharmacist supervision, where the pharmacy and pharmacist must maintain detailed sales records in a specified format for Department of Health (DH) inspection (e.g., cough syrups containing less than 0.2 per cent codeine).
3. **Controlled Non-Prescription Drugs without Mandatory Sales Records:** Products requiring pharmacy sale under registered pharmacist supervision without a mandatory requirement for specified sales records (e.g., anti-inflammatory and analgesic medications such as ibuprofen).
4. **Part 2 Poisons Over-the-Counter (OTC) Medicines:** Products containing Part 2 poisons (e.g., analgesics like paracetamol and antihistamines like chlorpheniramine found in common cold remedies), which may be retailed by both pharmacies and listed sellers of poisons, including common convenience stores and drug stores.
5. **Non-Poisons List OTC Medicines:** Products containing no substances listed on the Poisons List (e.g., certain mucolytics), which may be sold at general retail outlets.
### Import Controls and Personal Baggage Exemptions
The import and export of pharmaceutical products fall under the Import and Export Ordinance (Cap. 60). Standard importation mandates an import licence issued by the Department of Health under authority delegated by the Director-General of Trade and Industry.
However, regulation provides specific relief for personal use. Under the Import and Export (General) Regulations (Cap. 60A), an inbound traveller entering Hong Kong is exempted from applying for an import licence when carrying a "reasonable quantity" of pharmaceutical products in accompanied personal baggage for personal use.
Officers of the Customs and Excise Department (C&ED) assess whether a quantity is "reasonable" on a case-by-case basis. In making this evaluation, C&ED officers consider:
- Individual personal circumstances of the traveller;
- Relevant supporting information supplied at entry;
- Product packaging and labelling;
- Technical consultation with the Department of Health, where necessary.
Crucially, if the carried pharmaceutical products fall under specific statutory schedules—such 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 valid doctor's prescription is statutorily required for transport across the Hong Kong border.
### Enforcement Figures and Statutory Penalties
Hong Kong law imposes severe criminal penalties for unauthorized activities involving pharmaceutical products:
- Under Cap. 138, illegal sale or possession of unregistered pharmaceutical products or Part 1 poisons carries a maximum penalty upon conviction of a fine of HK$100,000 and two years' imprisonment.
- Under Cap. 60, importing or exporting pharmaceutical products without a valid licence carries a maximum penalty upon conviction of a fine of HK$500,000 and two years' imprisonment.
According to government figures provided in the reply:
- Over the past three years, C&ED detected 1,043 cases involving suspected illegally imported pharmaceutical products, seizing articles valued at approximately HK$364 million, with prosecutions instituted in 140 cases.
- Between January 2023 and September 2026, the Department of Health handled 108 conviction cases involving the illegal sale or possession of unregistered pharmaceutical products. Penalties imposed in these convictions reached up to 10 months' imprisonment or fines up to HK$242,000.
### Mechanism for Substance Review and Reclassification
The Poisons Committee (the Committee) established under the Board continually reviews the classification and distribution of substances on the Poisons List. Comprising technical experts, the Committee recommends statutory adjustments to ensure regulatory controls match evolving safety data.
Reclassifications and updates are enacted through amendments to Cap. 138A via Hong Kong's negative vetting legislative procedure. Between 2025 and September 2026, new chemical substances were added to the Poisons List and associated schedules across 68 new drug registration applications, while one existing drug classification was formally revised following updated safety evaluations.
### Frequently Asked Questions
**Q1: Do inbound travellers need an import licence to bring foreign medicines into Hong Kong for personal use?**
A: Under Cap. 60A, inbound travellers carrying a reasonable quantity of pharmaceutical products in their accompanied personal baggage for personal use are exempt from import licence requirements. However, if the medicines contain dangerous drugs (Cap. 134), antibiotics (Cap. 137), or Part 1 poisons (Cap. 138), a valid doctor's prescription is required.
**Q2: How do border officials determine if an imported quantity of medicine is "reasonable"?**
A: Customs and Excise Department (C&ED) officers perform case-by-case assessments by evaluating individual circumstances, provided documentation, product packaging, and, where needed, consulting the Department of Health.
**Q3: What are the maximum penalties for selling or possessing unregistered medicines in Hong Kong?**
A: Under Cap. 138, illegal sale or possession of unregistered pharmaceutical products or Part 1 poisons carries a maximum penalty of a HK$100,000 fine and two years' imprisonment upon conviction. Unlicensed importation under Cap. 60 carries fines up to HK$500,000 and two years' imprisonment.
**Q4: How does the Hong Kong government update the list of regulated poisons and medicines?**
A: The Poisons Committee under the Pharmacy and Poisons Board regularly reviews substances. Recommended changes to Cap. 138A are implemented through Hong Kong's negative vetting procedure in the Legislative Council.
Who May Be Affected
Inbound travellers, retail pharmacies, drug stores, healthcare professionals, and pharmaceutical distributors in Hong Kong SAR.
Cross-Border Context
Applies to travellers bringing foreign-purchased over-the-counter and controlled medicines across the border into Hong Kong SAR.
What to check next
- Check Department of Health Drug Office guidance on Part 1 poisons and drug registration lists.
- Monitor negative vetting updates to Schedule 10 of Cap. 138A in the Legislative Council.
This article provides general information and does not constitute legal advice. Consult the official text and obtain advice appropriate to your circumstances where needed.