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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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.
Q142 · 对于需要冷链运输和储存的药品（如疫苗），对相关操作人员有何特殊的资格或培训要求？独立链接
Personnel handling medicines that require cold chain management (Cold Chain Products) are subject to stringent training and qualification requirements set by the regulatory authorities. All employees involved in receiving, storing, packing, transporting and distributing cold chain medicines must receive specific training. The training must cover: 1) the basic principles and importance of the cold chain; 2) the specific temperature requirements for different medicines (such as 2-8°C); 3) how to use and read temperature monitoring equipment correctly (such as data loggers); 4) the correct use of cold chain packaging (such as cool boxes and cool packs); 5) emergency procedures for temperature excursions; and 6) relevant record-keeping and documentation requirements. The person overseeing cold chain operations (usually the RP or their delegate) needs more in-depth knowledge to be able to validate the effectiveness of cold chain equipment and processes.
Q143 · 如果持有药品牌照的公司发生了重大的股权变更，例如被另一家公司收购，是否需要重新申请牌照？独立链接
This depends on the circumstances, but a completely new application is generally not required; instead, strict notification and approval procedures must be followed. When a licensed company undergoes a major shareholding change or transfer of control, the legally licensed entity (that is, the company as a legal person) remains unchanged, so the licence itself remains valid. However, the company must immediately notify the Drug Office, Department of Health, in writing of this major change. The new major shareholders, directors and ultimate beneficial owners must submit their personal particulars to the Pharmacy and Poisons Board (PPB) and undergo a “fit and proper person” assessment. The PPB must be satisfied that, under the new control, the company can and will continue to comply with all licence conditions. In some cases, if the PPB has concerns about the new shareholders’ background or intentions, it may impose additional licence conditions or conduct inspections more frequently.
Q144 · 处理细胞毒性药物或其他危险药品的人员，需要具备哪些特殊的资格和防护培训？独立链接
Personnel handling hazardous drugs such as cytotoxic drugs must receive more stringent and specialised training than personnel handling ordinary drugs. Their qualifications and training are essential to occupational safety and the prevention of environmental contamination. Training must cover: 1) the characteristics and potential hazards of hazardous drugs (such as carcinogenicity and teratogenicity); 2) the correct selection and procedures for putting on and removing personal protective equipment (PPE), such as double gloves, protective gowns, goggles and respiratory protective equipment; 3) procedures for handling hazardous drugs in a dedicated negative-pressure isolator or biological safety cabinet; 4) emergency procedures for accidental spills and exposure incidents; and 5) the correct classification, labelling and handling of hazardous drug waste. Only employees who have completed the training and passed the assessment may be authorised to handle these high-risk products.
Q145 · 药剂业及毒药管理局（PPB）对申请人的背景审查范围有多广？会调查海外记录吗？独立链接
The PPB's background checks on key applicants (such as directors, UBOs and RPs) are extensive and in-depth, and are by no means limited to Hong Kong. The purpose is to assess comprehensively whether the person meets the “fit and proper” standard. Checks typically include: 1) identity verification; 2) criminal record checks (the applicant may be asked to authorise a criminal record certificate check); 3) checks of bankruptcy and company director disqualification records; 4) searches of publicly available information, including news reports and social media; and 5) verification of the applicant's declared academic and professional qualifications. For applicants with overseas backgrounds, the PPB may require overseas criminal record certificates and will pay particular attention to any adverse records with regulatory authorities in other countries, whether in medicines, finance or other sectors. Although cross-border checks can be complex, applicants are responsible for providing all relevant information and documents as requested.
Q146 · 如果一个人曾是某家药品牌照被吊销的公司的董事，他还能在新的申请公司中担任董事吗？独立链接
This situation will be subject to very stringent scrutiny, and the chances of success are slim, but it is not absolutely impossible. If a person has served as a director of a company whose licence was revoked, the PPB will conduct an extremely thorough investigation when assessing their eligibility to serve as a director of a new company. The PPB will focus on the following points: 1) What were the specific reasons for the company’s licence being revoked? Did they involve serious dishonesty or a significant threat to public health? 2) What role did the director play in the events leading to the revocation? Did they actively participate, knowingly fail to report the matter, or genuinely have no knowledge of it while fulfilling their duties as a director? 3) Has the director shown any reflection or improvement since the events? They must be able to provide highly persuasive evidence that they have learned significant lessons and that the new applicant company has established robust checks and oversight mechanisms to prevent a recurrence.
Q147 · 公司是否需要为负责人员（RP）或注册药剂师设立“后备”或“代理”人选？独立链接
There is no legal requirement to formally appoint a “deputy” or “stand-in” RP or pharmacist for a licence application or day-to-day operations. The statutory requirement is that a qualified, approved key person must be available at all times. However, from the perspective of sound operations and risk management, having an effective succession or temporary cover plan is highly advisable and professional. Large wholesalers or manufacturers commonly appoint a deputy or senior manager who has the potential qualifications to become an RP and is familiar with all relevant duties, so that they can take over promptly if the RP is on leave or leaves unexpectedly. A pharmacy cannot have two pharmacists-in-charge of sale at the same time, but it can establish contacts with locum pharmacists so that temporary cover can be arranged to maintain lawful operations if the pharmacist-in-charge is ill or on leave.
Q148 · 对于计划提供“远程药事服务”或“网上药房”业务，对相关人员有何特殊的资格要求？独立链接
Regulation of “remote pharmacy services” and “online pharmacies” in Hong Kong is still evolving. The core principle, however, is that any dispensing and sale of prescription medicines must take place under the direct supervision of a registered pharmacist and comply with all applicable pharmaceutical regulations. This means that even if a prescription is received through an online platform, the final review, dispensing, checking and supply of the medicine must be carried out in person by a registered pharmacist at physical premises holding a valid Authorised Seller of Poisons (ASP) (pharmacy) licence. Pharmacists responsible for online consultations must also be registered pharmacists in Hong Kong. In addition, the IT systems, data privacy safeguards and medicine delivery arrangements (particularly for cold-chain medicines) used throughout the process must be designed and managed by personnel with the relevant expertise to ensure that the service is safe, compliant and traceable.
Q149 · 药品批发商的负责人员（RP）或药房的注册药剂师，是否必须是香港永久性居民？独立链接
Not necessarily. Hong Kong’s medicines regulatory legislation does not make Hong Kong permanent residency a statutory requirement for appointment as an RP or registered pharmacist. Any non-permanent resident holding a valid Hong Kong work visa may take on these key roles, provided that they meet the relevant professional qualification, academic and experience requirements and pass the regulatory authority’s review or approval (such as a PPB interview or pharmacist registration). For example, a pharmacist holding a foreign passport may be employed by a pharmacy if they pass the Hong Kong licensing examination and are successfully registered. Similarly, a foreign expert holding a work visa may be appointed as the RP of a medicine wholesaler if they have the required experience and knowledge. What matters is their professional competence and lawful work status, not their category of residency.
Q150 · 为了维持资格，负责人员（RP）和注册药剂师是否有持续专业发展（CPD）的强制要求？独立链接
Yes, continuing professional development (CPD) is essential to maintaining the professional standards and qualifications of key personnel. The Pharmacy and Poisons Board (PPB) has implemented a mandatory CPD programme for registered pharmacists. Pharmacists must complete the prescribed number of CPD credits within a specified cycle (for example, three years) in order to renew their practising certificates. CPD activities take various forms, including attending academic lectures and seminars, completing online courses and publishing research. Although there is currently no mandatory credit system for RPs of pharmaceutical wholesalers and manufacturers as there is for pharmacists, “continuing training” is a basic requirement of Good Distribution Practice/Good Manufacturing Practice (GDP/GMP). Licensed companies are responsible for providing RPs with ongoing training on regulatory updates, new technologies and industry best practices, and for keeping all training records. During inspections, the regulatory authority will assess whether the RP's knowledge is up to date.
Q151 · 申请香港药品批发商牌照，对营业处所的最低面积有无具体要求？独立链接
When assessing applications for pharmaceutical wholesale dealer licences, the Drug Office, Department of Health, does not prescribe a minimum floor area for business premises in the regulations. This does not mean, however, that any floor area will suffice. The key principle is that “the area of the premises must be appropriate to the scale of the business and the types of medicines handled”. Inspectors will assess a range of factors, including the quantity and types of medicines you plan to store and handle, their storage requirements (such as ambient temperature or refrigeration), and whether processing or packaging will be required. If a space is too small to meet functional zoning requirements—for example, if it has no separate quarantine area pending examination, released-goods area, returns area or office—or if medicines are stored in a disorderly manner with a high risk of cross-contamination, the licence application is very likely to be refused. The floor area should therefore be sufficient to clearly separate each functional area and ensure the safe, orderly storage and handling of medicines.
Q152 · What are the key principles for planning a medicine warehouse layout to meet Department of Health requirements?Direct link
The layout of a medicine warehouse is key to ensuring medicine quality and safety. It must follow the principles of clear workflow, physical segregation and prevention of cross-contamination. First, clearly defined functional areas must be established, including receiving, quarantined goods pending examination, released goods, non-conforming goods (including returned, recalled, expired or damaged medicines) and dispatch areas. There should be clear physical boundaries between areas, for example, walls, partitions or clearly marked floor areas. Second, the layout should ensure a one-way workflow from receiving to dispatch, without crossing paths, to avoid confusion between medicines that have passed examination and those pending examination or deemed non-conforming. In addition, dedicated storage areas meeting the relevant requirements must be provided for medicines with special storage conditions (such as refrigeration, protection from light or controlled poisons).
Q153 · What specific technical requirements apply to temperature and humidity control systems for medicines requiring temperature-controlled storage?Direct link
For medicines requiring constant-temperature storage (usually in the range of 15-25°C), the temperature and humidity control system is a core facility for ensuring medicine stability. The technical requirements mainly include the following. First, a commercial-grade air-conditioning system capable of covering the entire storage area and operating continuously must be installed. Second, calibrated temperature and humidity loggers must be installed at multiple representative locations in the warehouse for uninterrupted 24/7 monitoring. These locations should include the centre and corners of the warehouse, and areas near doors, windows or heat sources. Third, the system must have high- and low-temperature alarms that immediately notify designated personnel by audible and visual alerts, text message or email when temperature or humidity falls outside the preset range. Finally, all temperature and humidity data must be fully recorded and retained for at least one year after the medicines’ expiry dates, so that the Department of Health can inspect them at any time.
Q154 · How should a medicine warehouse be effectively divided into zones, such as areas for quarantined goods pending examination, released goods and returned goods?Direct link
Effective zoning is fundamental to preventing medicine mix-ups and cross-contamination. First, each functional area must be clearly physically separated. Separate rooms or solid walls are ideal; if this is not possible, sturdy partitions, barriers or cage trolleys must be used to create clear separation. Second, every area must have prominent, firmly affixed signs naming the area in both Chinese and English, such as “待验区/Quarantine Area”, “合格品区/Approved Stock Area” and “不合格品区/Rejected Stock Area”. Third, the movement of materials between areas must be strictly controlled by procedures. For example, all newly received medicines must first be placed in the quarantine area. They may only be moved to the released goods area after inspection by the quality control department and issue of release authorisation. Any returned, recalled or damaged medicines must be isolated immediately in the non-conforming goods area pending further action.
Q155 · 经营需要冷链储存的生物制剂，冷链设施（如冷库、冷藏车）需要满足哪些认证标准？独立链接
When handling medicines that require cold-chain storage, such as vaccines and insulin, cold-chain facilities must meet very stringent standards to ensure that the medicines remain within the specified temperature range (usually 2-8°C) throughout storage and transport. First, cold rooms and refrigerated vehicles must undergo a professional Temperature Mapping Study to demonstrate that temperatures at all points inside can be kept consistently within the required range. This validation must be carried out under both empty and fully loaded conditions. Second, all temperature-controlled equipment, including cold rooms, refrigerators, refrigerated vehicles and portable coolers, must be equipped with independent, calibrated temperature monitoring and alarm systems. Third, detailed Standard Operating Procedures (SOPs) must be established to cover all aspects, including routine use, cleaning, maintenance, calibration and emergency response (such as power failure). During transport, validated insulated shippers must be used together with temperature data loggers that record temperatures throughout the journey.
Q156 · What measures must a warehouse implement to protect medicines from pests and rodents?Direct link
Pest control in a medicine warehouse is an ongoing, systematic activity aimed at prevention, not just extermination. First, the building structure of the premises must be intact, with no holes or gaps through which pests can enter. Doors and windows should close tightly, and drainage outlets should have mesh covers to prevent rodents from entering. Second, the environment must be kept clean and hygienic. There must be no standing water, rubbish or food debris in or around the warehouse, to eliminate sources that attract pests. Third, an integrated pest management plan should be established, usually in partnership with a professional pest control service provider. The plan should include regular inspections, installation and maintenance of pest control devices (such as glue boards, traps and fly killers), and detailed records of all activity. Any insecticides or rodenticides used must be approved products that pose no contamination risk to medicines, and must not be sprayed directly in medicine storage areas.
Q157 · 药品批发商的安保系统需要具备哪些功能，以确保药品安全、防止盗窃？独立链接
Medicines, particularly controlled psychotropic medicines or high-value medicines, are targets for theft. An effective security system is therefore essential. Basic requirements include: first, physical security. The premises must have sturdy doors, windows and locks to restrict access by unauthorised persons. Areas where controlled medicines are stored (such as poison cabinets) must have additional reinforcement and locking measures. Second, an intruder alarm system. A professional burglar alarm system connected to a 24-hour security company must be installed, covering all entrances and key areas. Third, a video surveillance system (CCTV). High-resolution cameras should be installed at key locations such as entrances and exits, goods receiving and dispatch areas, and medicine storage areas. Footage must be retained for at least 30 days to support investigation and traceability in the event of an incident. Fourth, access control. A strict key management or access card system should be established to ensure that only authorised staff can enter medicine storage areas, with corresponding entry and exit records.
Q158 · 选择工业大厦还是商业楼宇作为药品经营处所，各有哪些利弊和合规考量？独立链接
Choosing an industrial building or commercial building as premises for a pharmaceutical business involves balancing cost, compliance and operational convenience. Industrial buildings generally offer lower rents, larger units, higher floor loading capacity and freight lifts, making them suitable for receiving and dispatching large volumes of medicines. However, some older industrial buildings may have poor hygiene and security, requiring additional investment in refurbishment. Commercial buildings are generally in convenient locations, with better building management and security and a better overall environment. However, rents are high, units are smaller, and there may be various restrictions on transporting goods, such as time-limited use of passenger lifts. From a compliance perspective, whichever type of building is chosen, you must ensure that the unit’s Occupation Permit and land lease allow it to be used as a ‘warehouse’ or for ‘non-domestic’ purposes.
Q159 · 在卫生署进行场地视察前，企业应如何准备，以确保顺利通过检查？独立链接
A premises inspection is one of the most critical steps in the licence assessment process, and thorough preparation is essential. First, all hardware and facilities must be in place and operational, including all functional areas, temperature and humidity monitoring systems, security systems and pest-control equipment. Second, all documents and records must be complete, organised and readily accessible. These include company registration documents; qualification evidence for the Person-in-Charge and key personnel; all Standard Operating Procedures (SOPs); temperature and humidity records; cleaning records; pest-control records; and staff training records. Third, provide pre-inspection training to all relevant staff to ensure that they understand their responsibilities, relevant SOPs and the premises layout, and can answer inspectors’ questions clearly and accurately. Finally, conduct a comprehensive internal self-inspection, simulating a Department of Health inspection to identify and correct all potential issues.
Q160 · 药品处所的装修材料和设施（如地面、墙壁、照明）有无特殊要求？独立链接
Yes, the finishing materials and facilities in medicine premises are subject to specific requirements, primarily to facilitate cleaning, prevent contamination and ensure proper storage conditions. Floors should be seamless, smooth, durable and easy to clean, for example, epoxy floor coating. Avoid tiles with joints, as dirt can accumulate in the gaps. Walls and ceilings should be even and free from cracks, with a surface coating that does not readily peel and is easy to clean. It is recommended that wall, floor and ceiling corners be coved to eliminate hard-to-clean areas. Lighting should be sufficiently bright to ensure that all operations (such as checking labels and inspecting the appearance of medicines) can be carried out with clear visibility, and lighting fixtures should be designed for easy cleaning. In addition, the design and installation of all pipes, light fittings, vents and other facilities should avoid surfaces and recesses that are difficult to clean.