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
找到 38 条结果，第 1／2 页。每页显示 20 条；无需启用 JavaScript。
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.
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.
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.
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.
Q30 · How does Hong Kong law define and regulate cosmeceuticals?Direct link
As with “health supplements”, “cosmeceutical” is not a legally defined category under Hong Kong law. Whether a product is treated as a “cosmetic” or a “pharmaceutical product” depends entirely on its ingredients and claimed effects. Under the Consumer Goods Safety Ordinance (Cap. 456), cosmetics are subject to its general safety requirements. However, if a “cosmeceutical” contains any Western medicine ingredient controlled under the Pharmacy and Poisons Ordinance (for example, certain antibiotics used to treat acne, hydroquinone used for skin whitening, or steroids), or is promoted as being able to treat or prevent a skin disease (such as eczema or psoriasis), it will be classified immediately as a “pharmaceutical product”. Once classified as a pharmaceutical product, it must comply with the full range of pharmaceutical regulatory requirements: the product must be registered (obtaining an HK-XXXXX number), and the seller must hold a pharmaceutical licence. As a result, many products sold overseas as “cosmeceuticals” may be regarded as medicines in Hong Kong and cannot be sold in ordinary cosmetics shops or department stores.
Q42 · 如果我的产品是一种中西药复方制剂，它将如何被规管？独立链接
Combination products containing both Western and Chinese medicines are subject to very close scrutiny in Hong Kong and are usually classified and regulated as Western medicines. Under the Pharmacy and Poisons Ordinance, any product containing a Western medicine ingredient listed in the Poisons List is classified as a “pharmaceutical product”, whether or not it also contains Chinese medicine ingredients. Such a product must therefore follow the full Western medicine regulatory pathway: it must be registered with the Pharmacy and Poisons Board (PPB) (and obtain an HK-XXXXX number), and its manufacturer, importer and distributor must hold the relevant Western medicine licences, such as a manufacturer’s licence or wholesaler’s licence. In assessing the product, the regulator will evaluate the safety and quality of both its Western and Chinese medicine ingredients. Claiming that a product is “all natural” or “herbal” when it has been found to contain illegally added Western medicine ingredients is an offence that regulators crack down on severely.
Q47 · 香港对传统草本药物（Traditional Herbal Medicines）的规管是怎样的？独立链接
Hong Kong's regulation of traditional herbal medicines depends mainly on their source and category. If a herbal medicine falls within the categories of “Chinese herbal medicine” or “proprietary Chinese medicine”, it is subject to comprehensive regulation under the Chinese Medicine Ordinance (Cap. 549). The trader must apply for a Chinese medicine trader licence, and the product (if it is a proprietary Chinese medicine) must also be registered. However, the legal status of “traditional herbal medicines” outside the Chinese medicine system (for example, Western herbal remedies such as St John's wort and echinacea) is less clear. They are generally regulated as ordinary foods or health products, provided they contain no Western medicine ingredients controlled under the Pharmacy and Poisons Ordinance and their claims do not relate to the treatment or prevention of disease. The Department of Health nevertheless monitors these products closely and may investigate if they are found to contain harmful substances or make false medical claims.
Q51 · 我想在香港开一家药房，专门销售处方药和监督售卖药物，应该申请哪种牌照？独立链接
If you plan to operate a retail pharmacy in Hong Kong that dispenses prescriptions and sells various Western medicines (including prescription medicines, medicines for sale under supervision and over-the-counter medicines), you must apply for an Authorised Seller of Poisons licence, commonly known as a “pharmacy licence” or “pharmacist licence”. This is the only licence under Hong Kong law that permits retail sale of all categories of pharmaceutical products (Part I and Part II poisons). The key requirement is that you employ a registered pharmacist to manage and supervise the shop full-time during business hours. The shop layout, facilities, security system and medicine storage conditions must also meet the stringent standards set by the Pharmacy and Poisons Board (PPB) to ensure the safety and quality of medicines.
Q58 · If my business involves both Western medicine and proprietary Chinese medicine wholesaling, do I need to apply for two separate licences?Direct link
Yes, you need to apply for two entirely separate licences. Western medicines and Chinese medicines are governed in Hong Kong by two different legal frameworks and regulatory authorities. Wholesale dealing in western medicines is regulated by the Pharmacy and Poisons Ordinance (Cap. 138), with applications reviewed and regulated by the Drug Office, Department of Health; you need to apply for a “Wholesale Dealer Licence”. Wholesale dealing in proprietary Chinese medicines is regulated by the Chinese Medicine Ordinance (Cap. 549), with the Chinese Medicine Regulatory Office (CMRO) under the Department of Health responsible; you need to apply for a “Wholesale Dealer Licence for Proprietary Chinese Medicines”. The application requirements, assessment criteria and requirements for personnel and facilities differ, and the licences are not interchangeable.
Q62 · What licence do I need to wholesale proprietary Chinese medicines, such as branded cold remedy granules and medicated oils?Direct link
If you plan to wholesale proprietary Chinese medicines, that is, purchase registered proprietary Chinese medicines from manufacturers or importers and distribute them to retailers (such as Chinese medicine shops, pharmacies and supermarkets), you must apply to the Chinese Medicines Regulatory Office (CMRO) for a “Wholesale Dealer Licence for Proprietary Chinese Medicines”. To apply for this licence, you need a business address and storage facilities that meet the required standards for storing proprietary Chinese medicines. As with a Western medicine wholesaler, you must establish a complete Quality Management System covering procurement, receipt, storage, distribution and recall procedures, and keep detailed transaction records.
Q81 · 香港法例中的“第一部毒药”和“第二部毒药”究竟如何区分？这对我选择牌照有何影响？独立链接
In Hong Kong, the Pharmacy and Poisons Regulations divide regulated Western medicines (i.e. “poisons”) into two main categories. Part I poisons (Part 1 Poisons) are the most strictly regulated category and generally include all prescription medicines (such as antibiotics and antihypertensive medicines), as well as certain medicines that must be sold under the supervision of a pharmacist (such as cough mixtures containing codeine). These medicines may only be sold by an Authorised Seller of Poisons (ASP) (a pharmacy) with a registered pharmacist on the premises, on a doctor's prescription or under a pharmacist's supervision. Part II poisons (Part 2 Poisons) are less strictly regulated non-prescription medicines, commonly known as “over-the-counter medicines”, such as most cold and flu medicines and pain relief tablets. These medicines may be sold by a pharmacy or by a Listed Seller of Poisons (LSP) (a medicine shop) with only a “qualified person” on the premises. This classification therefore directly determines your choice of retail licence: if you wish to sell Part I poisons, you must operate a pharmacy; if you sell only Part II poisons, a medicine shop is sufficient.
Q83 · 我持有“药行”牌照，可以售卖那些包装看起来像药品，但声称是“保健食品”的产品吗？独立链接
This is a grey area that requires very careful handling. The key is how the product is classified. If a product, despite having packaging (such as capsules or tablets) and marketing similar to those of medicines, is legally classified as a “food” or “health food” because of its ingredients and claimed effects, you may in theory sell it in a pharmacy because it is not regulated by the Pharmacy and Poisons Ordinance. However, if the product contains controlled Western medicine or Chinese medicine ingredients, or its label or advertising expressly or implicitly claims to treat, diagnose or prevent disease, it is highly likely to be classified by the Department of Health or the Chinese medicine regulatory office as a “pharmaceutical product” or “proprietary Chinese medicine”. In that case, selling it without the relevant licence, such as a Pharmacy licence or a proprietary Chinese medicine retailer licence, would be unlawful.
Q97 · 中成药的“注册”和西药的“注册”是一回事吗？流程和要求有何不同？独立链接
Registration of proprietary Chinese medicines and Western medicines is intended to ensure that medicines sold in Hong Kong are safe, effective and of controlled quality. However, these are two separate, parallel systems administered by different departments, with significant differences in their procedures and requirements. Registration of Western medicines is handled by the Drug Office, Department of Health, and requires submission of a complete dossier in the internationally used Common Technical Document (CTD) format, including detailed pharmacological, toxicological and clinical study data. Registration of proprietary Chinese medicines is handled by the Chinese Medicine Regulatory Office (CMRO), with requirements that focus more on demonstrating the product’s history of use, supporting literature, and quality control of raw materials and finished products. Although safety data, such as tests for heavy metals and pesticide residues, must also be submitted, the requirements and methods for demonstrating clinical efficacy differ significantly from those for Western medicines, with greater acceptance of traditional use data and documentary evidence.
Q111 · 申请中成药制造商牌照，对“获授权人”（AP）的资格有什么特殊要求吗？独立链接
Yes, the qualifications for the Authorised Person (AP) of a proprietary Chinese medicine manufacturer are distinct from those for a western medicine manufacturer. Under the Chinese Medicine Council of Hong Kong (CMCC) guidelines, the qualifications for an AP of proprietary Chinese medicines are more flexible to reflect the characteristics of the Chinese medicine industry. The nominee will generally need one of the following backgrounds: 1) a registered Chinese medicine practitioner in Hong Kong; 2) a pharmacist who has taken courses related to Chinese medicines; 3) a degree in Chinese pharmacy, Chinese medicine, pharmacy or a related discipline; or 4) at least 10 years' extensive experience in the manufacture, quality control or research and development of proprietary Chinese medicines. Whatever their background, the AP must demonstrate to the Chinese Medicines Board that they have a thorough understanding of Good Manufacturing Practice (GMP) for proprietary Chinese medicines and can supervise the entire production process to ensure product safety, efficacy and consistent quality.
Q115 · 申请中药材零售商牌照，对从业人员有什么具体要求？是否需要中医师资格？独立链接
The requirements for personnel working for a Chinese herbal medicine retailer differ from those for a Western medicine pharmacy. There is no mandatory requirement to have a registered Chinese medicine practitioner on the premises. However, the law requires one person to be responsible for supervising the business at a Chinese herbal medicine retail shop. This supervisor must have specific knowledge and experience in Chinese herbal medicines. Under the requirements of the Chinese Medicine Council of Hong Kong, the person must meet one of the following conditions: 1) be a registered or listed Chinese medicine practitioner; 2) have successfully completed a training course in retail of Chinese herbal medicines recognised by the Chinese Medicine Council of Hong Kong; or 3) have engaged continuously in the retail of Chinese herbal medicines for at least 10 years before the Chinese Medicine Ordinance came into effect. This means that a person who is not a Chinese medicine practitioner may still qualify as a supervisor by completing a recognised training course and obtaining a certificate.
Q124 · 申请中成药批发商牌照，对负责人员（RP）的资格要求和西药批发商有何不同？独立链接
The qualification requirements for the Responsible Person (RP) under a wholesale licence for proprietary Chinese medicines are more specific to the Chinese medicine sector than those for Western medicine wholesalers. Although both require the RP to have knowledge and experience in supervising the handling of medicines, the RP for proprietary Chinese medicines needs a deeper understanding of Chinese medicines. According to the guidance of the Chinese Medicines Board, the RP of a wholesaler of proprietary Chinese medicines would generally need to meet one of the following qualifications: 1) be a registered or listed Chinese medicine practitioner; 2) have completed a recognised course in Chinese materia medica or a related field; or 3) have at least 5 years’ experience in wholesale of proprietary Chinese medicines or related business. By comparison, the background requirements for an RP for Western medicines tend to be more focused on Western pharmacy or related sciences. An RP for proprietary Chinese medicines needs a sound understanding of their sources and authenticity, storage conditions (such as protection from damp and mould), and Hong Kong’s specific labelling and registration requirements for proprietary Chinese medicines.
Q131 · 如果我的公司主要业务是医疗器械，但部分产品（如含药贴布）被界定为药品，我需要为整个公司申请药品牌照吗？独立链接
Yes, you need to apply for the appropriate pharmaceutical licence for the part of your business that handles products classified as medicines. Hong Kong regulates medicines and medical devices separately, through the Department of Health's Drug Office and Medical Device Division respectively. If one of your products—for example, an analgesic patch containing a western medicine ingredient—is classified as a “pharmaceutical product” based on its ingredients, mode of action or claimed therapeutic effects, any import, wholesale, retail or manufacturing activities involving it must be conducted under the relevant pharmaceutical licence. Your main business being medical devices does not exempt you from the licensing requirements for your medicine business. The company must establish a separate area that complies with Good Distribution Practice (GDP) for storing and handling these medicines, and appoint a qualified RP.
Q133 · 申请药品牌照的公司，是否必须加入某个商会或行业协会？独立链接
There is no legal requirement for a company applying for a pharmaceutical licence to join any chamber of commerce or industry association. Licence applications and approvals are based entirely on whether the applicant meets the statutory requirements set by the Drug Office, Department of Health and the Pharmacy and Poisons Board. However, joining one or more reputable industry associations, such as the Hong Kong Association of the Pharmaceutical Industry and the Hong Kong Chinese Medicine Merchants Association, is generally regarded as a positive step. It can help the company obtain the latest industry information, regulatory updates and market developments, as well as provide a platform for networking and exchanging views with industry peers. Membership of a recognised industry association can also, to some extent, demonstrate the company’s commitment to industry standards and business ethics to regulators and business partners.
Q139 · 申请药品牌照，对人员培训的记录有什么具体要求？需要保存多久？独立链接
Training record management is an important part of a pharmaceutical quality management system, and regulators have clear requirements in this area. First, all staff involved in licensed activities must receive initial and ongoing training appropriate to their duties. Second, detailed records must be kept of every training activity. Training records should generally include the date, topic, outline of content, trainer’s name and qualifications, and the signatures of participating staff. For key training in Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP), it is also advisable to keep records of post-training assessments or evaluations. All such training records must be properly retained. As a general recommendation, retain records for at least 5 years or, where specific product expiry requirements apply, for the longer period.