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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Q161 · 如果药品仓库位于多层建筑的楼上，对电梯和搬运通道有何要求？独立链接
When a medicine warehouse is located on a floor above or below ground level, requirements for vertical transport and handling routes are critical. First, there must be a dedicated or sufficiently large freight lift, with dimensions and load capacity that can readily accommodate standard handling equipment such as pallets and roll cages. Passenger lifts must not be used to transport bulk medicines. Second, the routes from the loading bay to the lift, and from the lift to the warehouse entrance, must be unobstructed, level and clear, with sufficient width for handling equipment to pass and turn easily. The floor surfaces along these routes should also be durable and hard-wearing. Emergency arrangements must also be considered—for example, whether there is an alternative plan or procedure for urgent medicine transport if the lift breaks down. Although this may be difficult in practice, having a plan is better than having none.
Q162 · 对于需要避光储存的药品，除了存放在不透明容器中，处所在设计上还有什么要求？独立链接
For light-sensitive medicines, opaque original packaging or containers alone are not sufficient; the entire storage environment should take light protection into account. First, the storage area should be kept as far as possible from direct natural light. Windows should be fitted with blackout curtains or blinds, or covered with UV-blocking film. If windows cannot be fully avoided, medicine shelves should be positioned away from them. Second, lighting that does not emit significant amounts of ultraviolet radiation should be used. Traditional fluorescent tubes emit some ultraviolet radiation, which may affect medicine stability over prolonged exposure. LED lighting or other low-UV light sources are recommended. Finally, the relevant Standard Operating Procedures (SOPs) should clearly specify how light-sensitive medicines are to be handled. For example, during picking and packing, their exposure to strong light should be kept as short as possible.
Q163 · 药品仓库的清洁和消毒程序应如何制定和记录，才能符合GDP要求？独立链接
Establishing a compliant cleaning and disinfection procedure is fundamental to maintaining hygiene in the medicine storage environment. The procedure must be a written Standard Operating Procedure (SOP) and should include: 1. Scope of cleaning, covering all areas, including floors, walls, shelving and equipment. 2. Cleaning frequency, which may vary between areas—for example, daily cleaning of operational areas and weekly or monthly cleaning of high shelving. 3. Cleaning agents and disinfectants used, specifying the product name, concentration and method of use, and ensuring they will not contaminate medicines. 4. Cleaning tools, specifying dedicated tools (such as mops and cloths) and how they are to be cleaned and stored after use to prevent cross-contamination. 5. Cleaning methods, describing the operating steps in detail. 6. Record-keeping requirements: after each cleaning, the responsible person must sign and date the Cleaning Record Form. The disinfection procedure should be implemented when necessary, such as after a spillage or contamination incident, and documented in the same detail.
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.
Q165 · 对于储存受管制药物（危险药物），除了上锁的毒药柜，还有哪些额外的安保和记录要求？独立链接
Storage of drugs controlled under the Dangerous Drugs Ordinance (Cap. 134) (for example, certain potent analgesics) is subject to stricter security and record-keeping requirements than ordinary poisons. First, the storage facility must be a fixed, robust safe or vault; an ordinary locked cabinet is not sufficient. The safe must be secured to the building structure so that it cannot easily be removed as a whole. Second, access to and handling of these drugs must be very strictly controlled, usually through a dual-person, dual-lock or similar system, under which two authorised persons must be present for each operation. Third, and most importantly, a dedicated Dangerous Drugs Register must be maintained. Every receipt and issue must be recorded promptly and accurately, including the date, source or destination, quantity and signatures of the persons handling the transaction. The register must follow the prescribed statutory format and must not be altered.
Q166 · 仓库的消防安全需要符合哪些规定？是否需要安装特定的消防系统？独立链接
Fire safety in a medicine warehouse is a basic requirement for protecting people and property, and must strictly comply with the requirements of the Hong Kong Fire Services Department. First, the premises must be equipped with a sufficient number and appropriate types of fire-fighting equipment, such as portable fire extinguishers (dry powder, carbon dioxide, etc.) and fire hose reels, according to their area and the fire risk of the goods stored. All fire-fighting equipment must be placed where it is readily accessible, clearly marked, and inspected and maintained annually by a registered fire service installation contractor. Second, all fire escape routes, emergency exits and stairways must be kept clear and unobstructed; goods or other items must not be stored there. Emergency exit doors must be easy to open from the inside. Third, a fire detection and alarm system that complies with regulations (smoke detectors, fire alarm bells, etc.) should be installed. The Fire Services Department may also require automatic sprinkler systems in large or high-risk warehouses.
Q167 · 如果处所内部分区域需要改造或加建，需要向哪个部门申请？流程是怎样的？独立链接
In Hong Kong, any work on premises involving structural alterations, additions or major renovations must comply with the Buildings Ordinance (Cap. 123) and may require an application to the Buildings Department. This is known as a “building plan submission”. First, you must engage an Authorised Person (usually an architect, engineer or surveyor) to assess your alteration plans. If the plans involve structural safety, fire safety, sanitary facilities or other relevant matters, the Authorised Person will determine whether a formal submission is required. If so, they will prepare the plans and related documents and submit the application to the Buildings Department on your behalf. The Buildings Department will review whether the plans comply with building standards and safety requirements. Once approval has been obtained, you must also engage a registered contractor to carry out the works. After completion, the Authorised Person will apply to the Buildings Department for a “Certificate of Completion” (also known as a “satisfaction letter”) confirming that the works have been completed in accordance with the approved plans.
Q168 · 对于退回或召回的药品，在处所内应如何隔离和管理？独立链接
Managing returned or recalled medicines is a key closed-loop control in the pharmaceutical quality control system and must be strictly implemented. First, a physically segregated area must be established in the warehouse specifically for returned/recalled medicines, with clear and prominent signage such as “Returned/Recalled Products Area - Not for Use”. All medicines returned by customers or recalled under instructions from the manufacturer or Department of Health must be moved to this area immediately upon receipt and must not be mixed with released stock. Second, detailed records must be kept for each batch of returned/recalled medicines, including the medicine name, batch number, quantity, reason for return/recall, source and date received. These medicines should be treated as “non-conforming goods” and must remain segregated until the quality control department makes a final disposition decision (for example, destruction or return to the supplier).
Q169 · 在进行场地视察时，卫生署官员会重点关注哪些文件记录？独立链接
The Department of Health’s premises inspection involves far more than checking the physical facilities. Reviewing documents and records is central to assessing whether your management system is effective. Officers will examine your documents systematically, much like auditors. The documents they typically focus on include: 1. **Quality Management System documentation**: the quality manual and complete set of Standard Operating Procedures (SOPs). 2. **Personnel records**: CVs and qualification documents for key personnel (such as the Person-in-Charge and quality manager), and training records for all staff. 3. **Premises and equipment documents**: the premises tenancy agreement and floor plan, validation/qualification reports for major equipment (such as cold rooms and refrigerators), and calibration certificates for all monitoring equipment (such as thermometers). 4. **Operational records**: complete temperature and humidity monitoring records (including any reports investigating out-of-range readings), cleaning records, pest-control records, and goods-in and goods-out records. 5. **Product-related records**: supplier and customer qualification files, purchase orders and sales invoices for medicines, and records of returned goods and recall handling. 6. **Controlled medicines records**: where applicable, the Dangerous Drugs Register and poisons sales records.
Q170 · 如果药品在仓库内发生泄漏或溢出，应如何处理以确保存储环境不受污染？独立链接
Medicine leaks or spills must be handled promptly, safely and effectively in accordance with a pre-established emergency procedure. First, immediately isolate the affected area to prevent the contamination from spreading, and evacuate non-essential personnel. Operators must wear appropriate personal protective equipment (PPE), such as gloves and masks; if handling toxic or corrosive medicines, goggles and protective clothing may also be required. Second, use a dedicated spill kit to absorb and clean up the spill. A kit typically contains absorbent pads, absorbent powder, dedicated scoops and sealed bags. Do not rinse the spill directly with water, as this may spread contaminants into the drainage system. All contaminated materials, including spilled medicines, absorbents and contaminated packaging, must be collected in dedicated, clearly labelled sealed containers or bags and handled as chemical waste. Finally, after the area has been cleaned, it must be thoroughly cleaned and disinfected again, and checked by the quality department to confirm that no residue remains before it is put back into use. The entire incident response must be documented in detail.
Q171 · 药品仓库产生的废弃物（如过期药品、污染包装）应如何合法合规地处理？独立链接
Waste generated by a medicine warehouse, particularly expired, damaged or contaminated medicines, is chemical waste. Its disposal must strictly comply with Environmental Protection Department requirements in Hong Kong; it must never be discarded as ordinary rubbish. First, the company must register with the Environmental Protection Department as a “chemical waste producer”. Second, all medicines to be destroyed and packaging materials contaminated by them must be collected in dedicated, leak-proof containers labelled “chemical waste”, and kept in a secure designated area, strictly segregated from released goods. Third, a licensed “chemical waste collector” must be engaged to collect and dispose of the waste. Both parties must complete and sign a Trip Ticket, the statutory tracking document for waste from generation to final disposal. All relevant disposal records, including the destruction contractor’s qualification documents and Trip Tickets, must be properly retained for at least 12 months.
Q172 · 处所内是否需要为员工设立独立的更衣室、洗手间和休息区？独立链接
Yes, providing appropriate hygiene and rest facilities for employees is one of the requirements of Good Distribution Practice. The aim is to protect staff health and prevent medicines from being contaminated due to personal hygiene issues. The premises should have a sufficient number of clean, hygienic toilets. Toilets should be equipped with hand soap and hand-drying facilities (such as a hand dryer or paper towels), and display “Please wash your hands” notices. If employees need to wear workwear or protective clothing for their duties, a separate changing room should be provided for storing personal clothing and workwear to prevent cross-contamination. A rest area or pantry, separate from medicine storage and handling areas, should also be provided for employees to eat, drink and rest. Eating, drinking or storing food in medicine storage or handling areas is strictly prohibited, to avoid attracting pests and causing contamination.
Q173 · 存放文件和记录的区域（办公室）与药品储存区之间需要隔离吗？独立链接
Yes, the office area used to store documents and records must be separate from the medicine storage area. This separation is mainly for several reasons. First, offices are areas with high levels of staff activity, and separating them can reduce disturbance to the medicine storage environment and the risk of potential contamination. Secondly, offices do not usually require the strict temperature and humidity controls needed in a medicine warehouse. Separating the two can reduce energy costs and management complexity. Thirdly, paper documents and office equipment present a certain fire risk, so keeping them separate from the medicine storage area is a fire-safety measure. Ideally, the office should be a separate room. If space is limited, the office area must still be completely separated from the storage area by a partition wall or clear physical barrier, and activities in the office must not adversely affect the storage environment (such as temperature, humidity or cleanliness).
Q174 · 如果我选址的仓库旁边是餐厅或食品加工厂，会对牌照申请有负面影响吗？独立链接
The surrounding environment of a warehouse is one of the factors the Department of Health may consider when assessing an application. If your medicine warehouse is next to a restaurant, food-processing plant, refuse treatment facility or other premises that may be a serious source of pests, odours or contamination, this may negatively affect the licence application. The regulatory authority’s main concern is that these neighbouring activities may significantly increase the risk of your premises attracting and harbouring pests (such as cockroaches and rats). Even if your internal pest control is effective, pressure from the external environment may make the problem unmanageable. In addition, strong odours (such as cooking fumes) may enter the warehouse through the ventilation system, doors or windows and contaminate medicine packaging or even the contents. You will therefore need to demonstrate to the Department of Health that you have additional, highly effective measures to guard against these external risks.
Q175 · 如果业务涉及药品重新包装或贴标签，操作区域需要满足什么特殊条件？独立链接
If your business involves secondary packaging of medicines (such as assembling packs) or relabelling, the area where these operations take place must meet a higher standard than an ordinary storage area, approaching that of a basic cleanroom. First, it must be a physically separate, enclosed room with independent access control. Second, it should have its own filtered ventilation system to control airborne dust particles and prevent cross-contamination. The walls, floor and ceiling must be smooth, seamless and easy to clean. Third, there should be an anteroom at the entrance where staff change into dedicated clean workwear, shoe covers and head covers. Fourth, the outer packaging of all materials used for packaging (such as new labels and cartons) must be cleaned before entering the area. Finally, all operations carried out in the area must have detailed batch production records and be traceable.
Q176 · 设备的“校准”（Calibration）和“验证”（Validation）有何区别？哪些设备需要做？独立链接
“Calibration” and “validation” are related but distinct concepts in quality assurance. “Calibration” is the process of comparing and adjusting the reading of a measuring instrument, such as a thermometer or weighing scale, against a recognised and more accurate standard to ensure the reading is accurate. It is a periodic activity carried out on an individual instrument. For example, sending your warehouse thermometer to a qualified laboratory each year to compare it with the laboratory’s standard thermometer is calibration. “Validation” is a broader, more systematic process that provides objective evidence that a process, system or item of equipment can consistently produce results that meet predetermined specifications and quality attributes. It does more than check accuracy: it demonstrates reliability and stability. For example, temperature mapping of a new cold room demonstrates that every corner can consistently be maintained at 2–8°C. This is a systematic validation process.
Q177 · 对于仓库中即将过期或已经过期的药品，应如何管理以防误发？独立链接
Managing medicines by expiry date, particularly those nearing expiry or already expired, is central to inventory control. The aim is to strictly apply the “first expired, first out” (FEFO) principle and prevent expired medicines from entering the market. First, your inventory management system, whether a computerised WMS or a manual system, must accurately record the expiry date of each batch and sort stock by expiry date so that batches expiring sooner are picked first. Second, establish an “expiry-soon alert” mechanism. For example, the system could automatically flag all medicines due to expire within the next 6 months. Third, establish a specific procedure for handling flagged items approaching expiry, such as prioritising their sale or negotiating their disposition with the supplier. Fourth, once a medicine has expired, remove it from released stock immediately, transfer it to a physically segregated, clearly identified “non-conforming goods” or “expired goods” area, update the inventory records and await destruction under the chemical waste procedure.
Q178 · 药品仓库使用的计算机化库存管理系统（WMS），在数据安全和合规性方面有何要求？独立链接
A computerised Warehouse Management System (WMS) is central to modern pharmaceutical distribution, and its data security and compliance are critical. First, the system must be validated to demonstrate that it is accurate, reliable and consistent, and can meet all GDP requirements, such as expiry-date management and batch traceability. Second, the system must have robust access controls, with different permissions for users in different roles, such as warehouse administrators and quality managers, to prevent unauthorised changes to data. The creation, amendment or deletion of all critical data must be recorded in an immutable audit trail, showing ‘who, when, where and what was changed’. Third, reliable data backup and recovery procedures must be in place to prevent data loss caused by system failure, cyberattacks or disasters. The recoverability of backup data should be tested regularly.
Q179 · 为应对突发停电，药品仓库特别是冷链储存方面，需要制定怎样的应急预案？独立链接
A sudden power failure is a major risk for a medicines warehouse, particularly one storing cold-chain medicines. An adequate emergency plan should address several areas. First, **prevention and alerts**: all critical cold-chain equipment (cold rooms and refrigerators) should be connected to an uninterruptible power supply (UPS) and/or a backup generator. The temperature monitoring system itself should also have an independent backup battery and be able to send an alert to the person-in-charge immediately over a 4G/5G network in the event of a power failure. Second, **immediate response**: the plan should clearly identify the person responsible and their duties upon receiving an alert, such as going to the site immediately to check whether the generator has started or assessing the likely duration of the power failure. Third, **alternative arrangements**: if the power failure is expected to last a long time, beyond the capacity of the generator’s fuel supply or the UPS, the plan must provide for the safe transfer of medicines to an alternative storage site. This could be another compliant cold room with power, or emergency storage services arranged with a third-party logistics provider. All emergency operations must be documented in detail.
Q180 · 药品仓库的卸货和装货区域（Loading/Unloading Bays）在设计和管理上有哪些要求？独立链接
Loading and unloading areas are the points through which medicines enter and leave the premises, and their design and management are essential to protecting medicine quality. First, the area should provide sufficient protection from adverse weather, such as direct sunlight and rain, while medicines are being loaded or unloaded. Ideally, it should be fully enclosed or at least covered by a roof. Second, it should be well separated from the external environment, for example by using rapid roller shutters, to reduce the impact of insects, dust and temperature and humidity fluctuations on the warehouse interior. Third, the floor should be level and sturdy to facilitate the use of handling equipment. Fourth, the area must be clearly divided, with receiving and dispatch areas appropriately separated to prevent confusion between finished goods about to be dispatched and quarantined goods pending examination that have just been received. Finally, the area should be kept clean and orderly, free from clutter and sufficiently well lit to allow inspection of goods labels and appearance.