HONG KONG DRUG LICENSING
Hong Kong Drug Licence FAQs
Search 500 Hong Kong drug licence FAQs on applications, personnel, premises, quality systems, ongoing regulation, renewals and acquisitions.
Information status: The original FAQ material dates from 2025 and is provided for topic-based reference; it does not represent an individual verification of all 500 FAQs against current rules. For application, fee, renewal, change, product or prescription requirements, please refer to the current official forms and guidance.
Official information from the Drug Office Official information from the Chinese Medicines Board
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Q1 · How does Hong Kong's pharmaceutical licensing system work, and what does it primarily regulate?Direct link
Hong Kong’s pharmaceutical licensing system is a comprehensive and stringent legal framework governing the manufacture, sale, distribution and possession of pharmaceutical products (that is, western medicines) and Chinese medicines. Its principal legal bases are the Pharmacy and Poisons Ordinance (Cap. 138) and the Chinese Medicine Ordinance (Cap. 549). The main parties it regulates include manufacturers, wholesalers and retailers of western medicines, such as pharmacies and medicine companies, as well as manufacturers, wholesalers and retailers of Chinese medicines. Any company or individual wishing to conduct these activities in Hong Kong must apply for the relevant licence from the Drug Office, Department of Health, or the Chinese Medicine Regulatory Office, as appropriate to the nature of the business. For example, a wholesale dealer licence is required to conduct wholesale business in western medicines, while an Authorised Seller of Poisons Licence is required to operate a community pharmacy. The system aims to ensure that medicines on the market are safe, effective and of good quality, thereby protecting public health.
Q2 · The Pharmacy and Poisons Ordinance (Cap. 138) is central to Hong Kong's pharmaceutical licensing system. What are its main provisions?Direct link
The Pharmacy and Poisons Ordinance (Cap. 138) is the principal legislation regulating Western medicines and poisons in Hong Kong. It has a broad scope and principally covers the following areas: first, it establishes the Pharmacy and Poisons Board (PPB), which is responsible for matters such as pharmacist registration, pharmacy licensing and disciplinary proceedings. Second, it sets out the application, issue and regulatory requirements for various pharmaceutical product licences, including manufacturer licences, wholesale dealer licences and Authorised Seller of Poisons licences. Third, it establishes a Poisons List system, classifying regulated “poisons” by toxicity, use and potential risk, and imposing different levels of control on the sale of different categories. Fourth, it sets out detailed requirements for the labelling, packaging, advertising and sale of pharmaceutical products to ensure accurate information and consumer safety. Fifth, it empowers Department of Health inspectors to enter licensed premises to conduct inspections, take samples and investigate, to ensure that licence holders comply with the law.
Q3 · How does Hong Kong's Poisons List system work in practice?Direct link
Hong Kong’s Poisons List system is established under the Pharmacy and Poisons Regulations (Cap. 138A) and is central to the classification and management of medicines. The Poisons List appears in Schedule 10 to the Regulations, defines specified chemical substances or medicinal ingredients as poisons, and divides them into 2 main parts: Part I and Part II. Part I poisons carry higher potential risks, and their sale is strictly controlled. Part I poisons are further divided into 3 subdivisions: A, B and C. Subdivision A poisons, such as potent antibiotics and psychiatric medicines, may be sold only at a registered pharmacy under the supervision of a registered pharmacist and on a doctor’s prescription. Subdivision B poisons must also be sold at a pharmacy under a pharmacist’s supervision, but in some circumstances no prescription is required. Subdivision C poisons may be sold at pharmacies or licensed medicine shops (Listed Sellers of Poisons). Part II poisons carry relatively lower risks and can generally be sold at various retail shops, such as supermarkets, without pharmacist supervision. Through detailed classification, this system ensures that high-risk medicines are used under professional guidance while making commonly used medicines accessible to the public.
Q4 · How are medicines classified in Hong Kong, and how are “prescription” and “non-prescription” medicines defined?Direct link
Medicines in Hong Kong are classified mainly according to their safety risks and whether they contain ingredients listed in the Poisons List. Broadly, they fall into three categories. The first is “prescription-only medicines”, which may be purchased only on a prescription issued by a Hong Kong-registered doctor and under the supervision of a registered pharmacist at a registered pharmacy. They are usually Part I poisons in Substance A of the Poisons List, used to treat more serious conditions and carrying a high risk of misuse. The second is “medicines that may be sold under the supervision of a pharmacist”. These do not require a prescription but must be purchased at a pharmacy under the supervision of a registered pharmacist. They usually comprise Part I poisons in Substance B of the Poisons List. The third is “non-prescription medicines”, also known as proprietary medicines or over-the-counter (OTC) medicines. These may be purchased freely at pharmacies, medicine shops and even some supermarkets and convenience stores. They can be further divided into “Part II poisons” and “non-poison” medicines. This classification system seeks to balance convenient access to medicines with safety, ensuring that higher-risk medicines are used with professional guidance.
Q5 · What are Hong Kong's main pharmaceutical regulatory bodies, and what are their respective responsibilities?Direct link
Several bodies are involved in Hong Kong’s medicine regulatory system. Each has its own responsibilities, and together they safeguard medicine safety. The main bodies include: 1. **Drug Office, Department of Health**: The central executive body, responsible for most regulatory functions under the Pharmacy and Poisons Ordinance and the Chinese Medicine Ordinance. Its duties include reviewing medicine registration applications; assessing and issuing various pharmaceutical licences for manufacturers, wholesalers and retailers; controlling medicine imports and exports; monitoring and inspecting medicines; and recalling medicines. 2. **Pharmacy and Poisons Board (PPB)**: A statutory body mainly responsible for pharmacist registration and disciplinary matters, as well as licensing and regulating Authorised Sellers of Poisons (that is, pharmacies). Applications for medicine product registration are also initially reviewed by the Drug Office before being submitted to a committee under the PPB for final approval. 3. **Chinese Medicine Regulatory Office (CMRO)**: Part of the Department of Health, it is specifically responsible for administering the Chinese Medicine Ordinance and regulating Chinese herbal medicines and proprietary Chinese medicines, including the licensing of Chinese medicine traders, registration of proprietary Chinese medicines and registration of Chinese medicine practitioners. Together, these three bodies form the core of Hong Kong’s medicine regulatory system, ensuring that western and Chinese medicines, products and practitioners are all subject to close legal regulation.
Q6 · What important historical amendments have been made to Hong Kong's pharmaceutical licensing legislation, and how have they affected the industry?Direct link
Hong Kong’s pharmaceutical licensing legislation is not static; it continues to evolve in response to changing circumstances and public health needs. Several important amendments have had a far-reaching impact on the industry. For example, the Chinese Medicine Ordinance (Cap. 549), enacted in 1997, was a landmark reform. It brought Chinese medicine within a statutory regulatory framework for the first time, requiring Chinese medicine traders to be licensed and proprietary Chinese medicines to be registered, and fundamentally changing an industry that had previously lacked uniform standards. In recent years, in response to the growing issues of cross-border e-commerce and personal imports of medicines, the Government has reviewed and tightened the exemptions for medicine imports under the Import and Export Ordinance (Cap. 60). Requirements for pharmacovigilance have also been strengthened, requiring licence holders to establish more comprehensive systems for reporting adverse drug reactions. Overall, the trend is towards increasingly scientific, systematic and stringent regulation. For the industry, this means higher compliance costs, but it has also encouraged professionalisation and the development of a more competitive sector, strengthening the industry’s reputation and international competitiveness.
Q7 · What is distinctive about Hong Kong's pharmaceutical licensing system compared with those of other countries or regions?Direct link
Hong Kong’s pharmaceutical licensing system is known internationally for its rigour and efficiency. Its distinctive features include the following. First, it operates within an “English-style” common law system, where case law and legislation are both important. Regulatory authorities have a degree of discretion in enforcement, but the overall framework is clear and transparent. Second, Hong Kong operates a dual system of “medicine registration” and “business licensing”. A medicine must first obtain product registration to demonstrate that it is safe, effective and of acceptable quality; only then can a company holding the relevant business licence, such as a wholesale dealer licence, handle it. Third, Hong Kong is a major international hub for pharmaceutical procurement and re-export. Its regulatory system is closely aligned with international standards such as PIC/S Good Manufacturing Practice (GMP), and is recognised by many countries. Medicines registered and companies licensed in Hong Kong therefore often enjoy certain advantages when entering other markets. Fourth, systematic statutory regulation of Chinese medicine is a distinctive feature and is relatively advanced globally. Overall, Hong Kong’s system strikes a good balance between protecting public health and promoting the development of the pharmaceutical industry.
Q8 · What requirements apply to the key personnel of a company applying for a pharmaceutical licence in Hong Kong?Direct link
When applying for various pharmaceutical licences in Hong Kong, the regulatory authorities attach great importance to whether the applicant company’s key personnel have appropriate qualifications and experience. The specific requirements vary by licence type. For a Wholesale Dealer Licence, the company must appoint a Responsible Person (RP) who can demonstrate sufficient knowledge and experience to oversee the wholesale business and ensure compliance with Good Distribution Practice (GDP) requirements. A Manufacturer of Pharmaceutical Products licence requires a qualified Authorised Person (AP) and production manager, who must have academic qualifications in pharmacy, chemistry or a related discipline and extensive experience in pharmaceutical manufacturing and quality control. For a Pharmacy / Authorised Seller of Poisons (ASP) licence, the law expressly requires the business to be ‘personally managed and controlled’ by a registered pharmacist. These key personnel are central to ensuring that the licence holder continues to comply with regulations and safeguards medicine quality, so their qualifications and backgrounds are subject to strict scrutiny by the Department of Health.
Q9 · What is Good Distribution Practice (GDP), and what does it mean for pharmaceutical licence holders?Direct link
Good Distribution Practice (GDP) is a set of quality management standards for the wholesale and distribution of medicines. It aims to ensure that the quality and integrity of medicines are maintained throughout the supply chain, from the manufacturer to the final retail outlet. GDP covers every aspect of medicine distribution, including establishing a quality management system; personnel qualifications and training; premises and equipment requirements, particularly storage conditions such as temperature and humidity control; order processing; receipt; storage; picking; dispatch; handling returns; and monitoring transport. For holders of a “wholesale dealer licence” in Hong Kong, compliance with GDP is not optional but a mandatory legal requirement. The Drug Office, Department of Health, conducts regular inspections of licensed wholesalers against GDP standards. Any serious GDP breach may result in the licence being suspended or revoked. GDP is therefore the fundamental operating standard for every wholesale medicines business.
Q10 · How does Hong Kong's pharmaceutical licensing system deal with parallel imports (grey-market medicines)?Direct link
In Hong Kong, “parallel-imported” or “grey-market” medicines refer to genuine medicines purchased from overseas markets by importers who are not authorised by the original manufacturer and imported into Hong Kong for sale. Parallel-imported medicines are legal under Hong Kong law if two core conditions are met. First, the medicine must already be registered in Hong Kong, that is, it must have a Hong Kong registration number (HK-XXXXX). Unregistered medicines may not be sold in Hong Kong, regardless of whether they are legal overseas. Second, the company importing and selling the medicine must hold a valid wholesale dealer licence and/or the relevant retail licence. The labelling of parallel-imported medicines must comply with Hong Kong legal requirements, for example by including the Hong Kong registration number and importer’s name. Although parallel importation is legal, the regulatory authorities strictly regulate these products to ensure that their quality has not been affected during transport and storage and that their source is traceable.
Q11 · What licence do I need to open a pharmacy in Hong Kong, and what are the main steps?Direct link
To open a retail pharmacy in Hong Kong, you need to apply for an “Authorised Seller of Poisons Licence”, commonly known as a “pharmacy licence”. This licence is issued by the Pharmacy and Poisons Board of Hong Kong (PPB). The main steps are as follows: first, you must establish a Hong Kong limited company and find retail premises that meet the requirements of the Code of Practice for Authorised Sellers of Poisons. Next, you must employ one or more registered pharmacists and ensure that a pharmacist is on duty throughout all business hours. You then need to prepare detailed application documents, including company information, a premises layout plan, the pharmacists’ registration certificates and employment contracts, and submit the application to the PPB Secretariat (operated by the Drug Office, Department of Health). After submission, the Drug Office will arrange a site inspection to check whether the layout, facilities, security system and medicine storage conditions comply with the requirements. Finally, if the inspection is passed and all documents are complete, the PPB’s Licensing Committee will consider your application. If successful, the licence will be issued.
Q12 · What is a Listed Seller of Poisons (LSP) Licence, and how does it differ from a pharmacy licence?Direct link
The Listed Seller of Poisons Licence is intended for retail shops commonly known as “medicine shops” or “drug stores”. The main difference from an Authorised Seller of Poisons (ASP) (pharmacy) licence lies in the range of medicines that may be sold and the personnel requirements. A pharmacy holding an ASP licence may sell all categories of medicines, including prescription medicines and medicines sold under supervision, because a registered pharmacist is on the premises. A medicine shop holding an LSP licence may sell only Part II poisons and “non-poison” proprietary medicines that contain no ingredients listed in any poison schedule. It may not sell prescription medicines or medicines sold under supervision. In terms of personnel, a medicine shop does not need to employ a registered pharmacist, but staff selling Part II poisons must have completed an approved training course. The threshold for entry is therefore relatively low, but the scope of business is also considerably restricted.
Q13 · What are the specific legal requirements for medicine labelling and packaging in Hong Kong?Direct link
Hong Kong has very strict and detailed requirements for the labelling and packaging of medicines to ensure consumers receive accurate and important product information. Under the Pharmacy and Poisons Regulations, the labels of all registered pharmaceutical products sold in Hong Kong must clearly state the following information: the product name, active ingredients and their quantities, Hong Kong registration number (in the format HK-XXXXX), manufacturer name, batch number and expiry date. Certain medicines may be subject to additional labelling requirements, such as warning statements reading “Poison”, “Prescription Only” or “To be sold under the supervision of a pharmacist”. Packaging must also protect the medicines against contamination and damage under normal handling and storage conditions. In addition, all information provided to consumers, including labels and package inserts, must be available in both English and Traditional Chinese. These requirements help ensure that both professionals and members of the public can use medicines safely and correctly.
Q14 · How are medicine advertisements regulated in Hong Kong?Direct link
Advertising of medicines in Hong Kong is strictly regulated, primarily under the Undesirable Medical Advertisements Ordinance (Cap. 231). The Ordinance aims to prevent anyone from publishing advertisements that may cause members of the public to delay seeking proper medical attention because of inappropriate self-diagnosis. Schedule 1 to the Ordinance lists various diseases and physical conditions, such as cancer, diabetes and sexually transmitted diseases, for which advertisements claiming that medicines can treat or prevent them may not be published to the public. The law also completely prohibits direct advertising of prescription medicines to the public. Only OTC medicines may be advertised to the public, subject to certain restrictions, and their claims must be truthful and accurate, and not misleading or exaggerated. All pharmaceutical advertisements are monitored by the Department of Health. Any non-compliant advertisement may be required to be removed immediately, and its publisher may be prosecuted.
Q15 · If I only want to sell health products online, do I also need a pharmaceutical licence?Direct link
This is a key question, and the answer depends on how your “health product” is classified under Hong Kong law. Hong Kong law does not have a statutory category of “health products”. A product is classified as a “pharmaceutical product” or a “non-pharmaceutical product” according to its ingredients and claimed effects, regardless of its market positioning or common name. If your product contains any Western medicine ingredient listed in the Poisons List under the Pharmacy and Poisons Ordinance, or its claimed effects meet the definition of a “pharmaceutical product” (that is, it is intended to diagnose, treat or prevent disease), it will be regarded as a pharmaceutical product. Once classified as a pharmaceutical product, it must first be registered in Hong Kong before it can be sold, whether in a physical shop or online, and the seller must hold the relevant pharmaceutical licence, such as a wholesaler licence. If your product contains no Western medicine ingredients and makes no therapeutic claims in its promotion, it may be regarded as an ordinary food and may not require a pharmaceutical licence. However, classification can be complex and requires case-by-case analysis.
Q16 · Approximately how much does a pharmaceutical licence cost? Are there also annual maintenance fees?Direct link
Government fees for a Hong Kong pharmaceutical licence are relatively low, but the main costs arise from the upfront investment needed to meet compliance requirements. Taking the most common type, a Wholesale Dealer Licence, as an example, under the Pharmacy and Poisons Regulations the application fee for a first application is HKD 1,030. If the application is approved, the licence issuance fee is HKD 2,150. The licence is usually valid for one year, and the annual renewal fee is HKD 2,150. For a “Listed Seller of Poisons” licence, the application fee is HKD 455, while the licence fee and annual fee are calculated according to the rateable value of the shop. These are government fees only. In practice, the greater costs include leasing and fitting out a warehouse or shop to GDP/GSP standards, establishing a compliant Quality Management System (QMS), salaries for qualified key personnel (such as a responsible person or pharmacist), and any consultancy fees. Total upfront investment should therefore be budgeted in detail according to the scale of the business.
Q17 · What rules does Hong Kong's pharmaceutical licensing system set for personal possession of medicines? Can I bring medicines for personal use into Hong Kong from overseas?Direct link
Hong Kong law provides exemptions for individuals possessing medicines for reasonable personal use and bringing personal-use medicines into Hong Kong from overseas. Under the Import and Export Ordinance (Cap. 60), travellers may bring a reasonable quantity of pharmaceutical products into Hong Kong for personal use. The legislation does not define “reasonable quantity”; Customs will generally assess it by reference to the nature and dosage of the medicine and the length of the traveller's stay. However, stricter requirements apply to medicines containing dangerous drugs controlled under the Dangerous Drugs Ordinance (Cap. 134), such as certain strong painkillers and psychiatric medicines, or antibiotics. A traveller bringing these medicines into Hong Kong must have a doctor's prescription, and the quantity must not exceed a course of treatment. Note that this exemption applies only to medicines carried in “personal baggage”; it does not cover items sent by post or courier. Importing medicines into Hong Kong by post, even for personal use, will almost certainly require an import licence.
Q18 · What is PIC/S GMP, and how does it relate to a pharmaceutical manufacturer licence in Hong Kong?Direct link
PIC/S GMP refers to Good Manufacturing Practice (GMP) established by the Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S is an international organisation of medicines regulatory authorities, intended to harmonise GMP standards and inspection procedures. The Department of Health in Hong Kong is a PIC/S member. This means that the standards used in Hong Kong to assess and issue a manufacturer's licence (GMP) are fully aligned with international PIC/S standards. Any company wishing to manufacture medicines in Hong Kong must ensure that its manufacturing facilities, quality management system, production processes and personnel qualifications fully meet the stringent PIC/S GMP requirements. By adopting the highest international standards, Hong Kong ensures that locally manufactured medicines can meet international quality standards and be recognised by other PIC/S members, such as EU countries, Australia and Canada, paving the way for exports.
Q19 · How are Chinese medicines regulated in Hong Kong, and how does this compare with the regulation of Western medicines?Direct link
Since the Chinese Medicine Ordinance (Cap. 549) came into force in 1997, Hong Kong has developed an independent and comprehensive legal framework for regulating Chinese medicine. The framework is administered by the Chinese Medicine Regulatory Office (CMRO) under the Department of Health. As with Western medicines, regulation covers both product registration and business licensing. All “proprietary Chinese medicines” sold in Hong Kong must be registered with the Chinese Medicines Board to demonstrate their safety, quality and stability. Companies engaged in Chinese medicine business must also apply for the appropriate licences according to the nature of their business, including licences for the retail of Chinese herbal medicines, wholesale of Chinese herbal medicines, wholesale of proprietary Chinese medicines and manufacture of proprietary Chinese medicines. One difference is that the regulation of Chinese medicine takes account of the particular nature of its traditional use. For example, when registering proprietary Chinese medicines, the requirements for evidence of safety and efficacy may differ between “classical formulae” with a long history of use and newly developed formulae. There are also specific testing standards for pesticide residues and heavy metal content in Chinese herbal medicines.
Q20 · If I find suspected counterfeit or non-compliant medicines on the market, which department should I report them to?Direct link
If you suspect that counterfeit or unregistered medicines are being sold on the market, or discover any non-compliant medicine sales (such as a drugstore selling prescription medicines), you should report it immediately to the Drug Office, Department of Health. The Drug Office has dedicated reporting channels, and members of the public can provide information by telephone, fax, email or post. When reporting, please provide as much detail as possible, including the suspected product's name, where and when it was purchased, the shop's name and address, and a description or photographs of anything suspicious. All reports will be handled confidentially. The Department of Health attaches great importance to reports from the public, as they are an important part of its medicine surveillance system. After receiving a report, the Drug Office will investigate and, if necessary, take enforcement action, including conducting inspections, taking samples for testing, requiring a product recall or even bringing criminal prosecutions. Safeguarding medicine safety is a shared responsibility, and your report may protect many people from harm.