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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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.
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.