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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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.
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.
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.
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.
Q61 · 我想开一家专门卖中药材的店铺，是申请中药材零售商牌照就可以了吗？独立链接
Yes, if you plan to open a retail shop in Hong Kong selling Chinese herbal medicines listed in Schedule 2 to the Chinese Medicine Ordinance (Cap. 549), you need to apply to the Chinese Medicine Regulatory Office (CMRO) for a retail licence for Chinese herbal medicines. This licence permits you to sell these traditional herbs to end consumers. In your application, you must demonstrate that your shop meets hygiene, storage and safety standards, and that you or your staff have sufficient knowledge of Chinese herbal medicines to provide customers with appropriate guidance. The shop must also have compliant measuring instruments, such as a traditional Chinese balance.
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.
Q63 · Can I apply at the same time for licences as a Chinese herbal medicine wholesaler and a proprietary Chinese medicine wholesaler?Direct link
Yes. If your business covers wholesale of both Chinese herbal medicines (such as crude herbal medicines and prepared slices) and proprietary Chinese medicines (such as capsules, pills and medicinal oils), you may, and must, apply for both a wholesaler’s licence for Chinese herbal medicines and a wholesaler’s licence for proprietary Chinese medicines. Both licences are approved by the Chinese Medicines Regulatory Office (CMRO), but they are different licence categories. You may operate from the same business address and warehouse, but must demonstrate to the CMRO that you can effectively manage the two types of products separately and prevent confusion. Your Quality Management System and record-keeping system must also be able to manage and trace the movement of Chinese herbal medicines and proprietary Chinese medicines separately.
Q64 · 我想在香港生产一款保健品，它含有一些草本成分，我需要申请药物制造商牌照还是中成药制造商牌照？独立链接
This is a very good question and reflects forward-thinking about business development. In Hong Kong, pharmaceutical products and medical devices are governed by two separate regulatory systems. Pharmaceutical products are regulated by the Drug Office, Department of Health, and the PPB, and you need to apply for the various pharmaceutical licences discussed above. Medical devices are regulated by the Medical Device Division (MDD) under the Department of Health. Hong Kong currently operates a voluntary listing system for medical devices, known as the Medical Device Administrative Control System (MDACS). Although listing is voluntary, most importers and distributors apply to list their medical devices to demonstrate product safety and efficacy and to supply public organisations such as the Hospital Authority. You must therefore submit a separate application to the MDD and demonstrate that your company meets the requirements of the Code of Practice for Medical Device Importers and Distributors under the Medical Device Administrative Control System, including having a Quality Management System (such as ISO 13485). The two application processes run in parallel and do not affect each other, but you must meet two different sets of regulations and standards.
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.
Q87 · 对于“配方颗粒中药”的监管，与传统中药饮片有何不同？我需要什么牌照来经营？独立链接
Formula granules for Chinese medicine (commonly known as ‘Chinese medicine granules’) are standardised granules made by extracting, concentrating and drying traditional Chinese herbal medicines and decoction pieces using modern technology. In Hong Kong, they are treated as a special form of Chinese medicine and are regulated between traditional Chinese herbal medicines and proprietary Chinese medicines. To trade in these products, you need a wholesaler’s and/or retailer’s licence for Chinese herbal medicines. However, because their production involves complex extraction and formulation processes, the Chinese Medicine Council of Hong Kong applies higher quality standards. Suppliers must be able to provide detailed quality documentation demonstrating that their granules meet Hong Kong standards for identification, content, pesticide residues, heavy metals and other aspects.
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.
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.
Q137 · 申请中成药制造商（GMP）牌照，对人员的卫生和健康有什么要求？独立链接
Proprietary Chinese medicine GMP (Good Manufacturing Practice) imposes strict hygiene and health requirements on all personnel involved in production, especially employees who come into direct contact with Chinese herbal medicines, semi-finished products or finished products. First, all relevant personnel must undergo a medical examination before taking up their duties to ensure that they do not have any infectious disease or skin condition that could contaminate medicines. Second, staff must receive systematic training in personal hygiene, including correct handwashing procedures and requirements for wearing clean work clothing. Before entering clean production areas, they must change into dedicated work clothing, footwear, headwear and masks. Eating, drinking, smoking and any other conduct that could contaminate medicines are strictly prohibited in production areas. If an employee develops any health condition that could affect medicine quality, such as a cold, diarrhoea or a skin wound, they must report it to their supervisor immediately and be temporarily reassigned from duties involving direct contact with products.
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.
Q141 · 一家公司是否可以同时持有多种类型的药品牌照，例如同时持有批发商和制造商牌照？独立链接
Yes. A company may apply for and hold more than one pharmaceutical licence, depending on its business needs. For example, a company that manufactures medicines and also sells them to other wholesalers, hospitals or pharmacies must hold both a manufacturer’s licence and a wholesaler’s licence. Similarly, a company may hold licences for both wholesale of proprietary Chinese medicines and wholesale of Western medicines. The key is that the company must meet the relevant statutory requirements for every licensed activity. This means that if it holds two types of licence, its facilities, personnel, Quality Management System and operating procedures must meet the regulatory standards for both licences, and it must be able to clearly demonstrate compliant operations under each licence during inspections.
Q164 · 如果我的业务同时涉及西药和中成药，是否可以在同一个仓库内储存？独立链接
It is permissible to store Western medicines and proprietary Chinese medicines in the same warehouse, but strict physical segregation and operational separation are required to prevent cross-contamination and mix-ups. First, the warehouse must have clearly defined, physically separated areas for Western medicines and proprietary Chinese medicines. Ideally, use separate rooms or separate them with solid walls. If this is not feasible, at least store them in different areas of the warehouse using a racking system and provide very clear labels. The handling processes for the two product categories (receipt, inspection, put-away, picking and checking) should be separated as far as possible, and they should not be handled at the same workstation or at the same time. In particular, some Chinese herbal medicines may have a strong odour or generate dust, so they must be strictly segregated from Western medicines to prevent odour or physical cross-contamination.
Q264 · 对于中成药制造商，建立一个符合GMP标准的厂房，其投资回报周期大概是多久？独立链接
Establishing a Chinese medicine factory that complies with Good Manufacturing Practice (GMP) is a long-term strategic investment. The payback period cannot be generalised, but is usually measured in years. Its length depends on several changing factors: 1. “Product portfolio and market positioning”: whether your medicines have exclusive patents, strong brand appeal or clear market demand. 2. “Sales channels and network”: whether you have an effective distribution network to bring products to market quickly. 3. “Production efficiency and cost control”: the level of production-line automation, yield and raw-material purchasing costs directly affect profit margins. 4. “Pricing strategy”: whether product prices can generate sufficient returns after covering high fixed-asset depreciation and operating costs.