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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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.
Q181 · 对于人员进出药品储存区，应如何进行有效的访问控制？独立链接
Access control in medicine storage areas is essential to safeguard medicines and prevent unauthorised access. An effective access control system should combine physical barriers with procedural controls. Physically, all entrances to storage areas should be locked and access restricted to authorised personnel. An electronic access control system (such as card or fingerprint access) is recommended instead of traditional keys. Electronic systems can assign different access permissions to each employee and generate detailed entry and exit records. Procedurally, a written Access Control Procedure must specify which roles have access and under what circumstances they may enter. Visitors, maintenance personnel and contractors, as well as other unauthorised persons, must be accompanied at all times by an authorised employee, and their identity, reason for visit, and entry and exit times must be recorded in a Visitor Register.
Q182 · 仓库员工的培训记录需要包含哪些内容，以证明其具备操作资格？独立链接
Staff implement the quality management system, and their training records are important evidence to the regulator that they are “competent” to perform their duties. A complete training file should systematically document all training received by an employee from induction through to their ongoing employment. It must include: 1. **Basic training**: training on the company's quality policy, basic pharmaceutical regulatory requirements (such as GDP) and personal hygiene requirements. 2. **Role-specific SOP training**: training on the SOPs relevant to each employee's role; for example, goods-receiving staff should be trained on the goods-receiving SOP and picking staff on the picking SOP. 3. **Specific skills training**: for cold-chain activities, training in cold-chain management and emergency procedures; for handling dangerous medicines, training in relevant legislation and safe handling procedures. 4. **Ongoing training**: regular updates on GDP and training on new SOPs. Each training record should include the date, subject, training materials and trainer, and, most importantly, the trainee's signature and assessment results (where applicable) as evidence that they have understood the training.
Q183 · 药品仓库的货架和托盘（卡板）在选择和使用上有什么要求？独立链接
Shelving and pallets are essential for medicine storage, and their selection and use directly affect the safety, orderly storage and cleanliness of medicines. First, for materials, preference should be given to smooth, durable metal or plastic that does not shed particles and is easy to clean. Untreated wooden shelving or pallets must not be used because wood can absorb moisture, develop mould, produce splinters and harbour pests. If wooden pallets must be used, they should be high-quality pallets that have been heat-treated or fumigated and bear the relevant marking (such as the IPPC mark). Second, all medicines, including their outer cartons, must be stored off the floor on shelves or pallets to protect them from damp and facilitate cleaning. Shelving and pallets should be cleaned regularly and checked for structural integrity and damage. Shelves must have sufficient load-bearing capacity for the weight of the medicines stored on them, with their load limits clearly marked.
Q184 · 仓库内的照明突然失效，是否有应急照明的要求？独立链接
Yes, to ensure personnel safety and, where possible, continuity of operations if the mains power supply is interrupted or the lighting system fails, a medicine warehouse must be equipped with emergency lighting. Emergency lighting usually has two components. The first is **escape lighting**, which illuminates escape routes and emergency exits during a power failure so that staff can evacuate safely and promptly. This is a statutory fire-safety requirement for all commercial and industrial premises. The second is **standby lighting**, which provides sufficient illumination to continue necessary or emergency operations when the main lighting fails, such as safely shutting down equipment, handling urgent medicine orders or transferring cold-chain products. The brightness requirements for standby lighting are usually higher than those for escape lighting. Emergency lighting units must have their own batteries and switch on automatically when the power fails.
Q185 · 我是否需要为仓库内的所有设备（如叉车、温湿度计）都制定标准操作程序（SOP）？独立链接
Yes, in principle, all critical equipment that affects medicine quality, staff safety or operational compliance should have a corresponding Standard Operating Procedure (SOP). The purpose of an SOP is to ensure that equipment is used, maintained and managed correctly and consistently, thereby reducing the risk of human error and equipment failure. Equipment for which SOPs are usually required includes: 1. **Environmental monitoring equipment**: for example, an SOP for a temperature and humidity monitoring system should cover how to read data, respond to alarms and carry out routine checks. 2. **Storage equipment**: an SOP for cold rooms and refrigerators should cover start-up and shutdown, defrosting, cleaning and emergency response. 3. **Handling equipment**: for example, SOPs for forklifts and pallet trucks should cover routine safety checks, operating procedures, charging/refuelling and maintenance. 4. **Measuring equipment**: an SOP for an electronic weighing scale should cover routine calibration checks (using standard weights) and cleaning. 5. **Security equipment**: SOPs for CCTV and alarm systems should cover arming and disarming the systems and retrieving footage.
Q186 · 仓库的承重能力（Floor Loading Capacity）需要证明吗？如何证明？独立链接
Yes, ensuring that the warehouse floor has sufficient load-bearing capacity to safely support the weight of all racking, medicines and equipment is a basic building safety requirement and, in some circumstances, must be demonstrated to the regulatory authority. This is particularly important if you plan to install heavy-duty, high-level racking or store products at a very high density. Load-bearing capacity can usually be demonstrated in the following ways. First, you can consult the building's original plans or Occupation Permit, which will usually state the design floor live load (typically in kPa, or kilopascals). Secondly, if you cannot find these documents, or your intended loading may exceed the original design standard, you must engage a Registered Structural Engineer (RSE) to conduct an on-site survey and structural calculations. The engineer will assess your current racking layout and maximum inventory weight and issue a professional assessment report confirming that the building structure is safe under the intended conditions of use.
Q187 · 如果我的药品批发业务规模很小，只是租用了一个小仓库，是否也需要满足所有GDP要求？独立链接
Yes, this is absolutely required. A fundamental principle of Hong Kong's pharmaceutical regulation is that all licence holders are treated equally. Regardless of the size of your business, if you engage in the wholesale, storage or distribution of medicines, you must fully comply with all applicable requirements of the Pharmacy and Poisons Ordinance and Good Distribution Practice (GDP). The regulatory authority's primary concern is the quality and safety of medicines, which is unrelated to company size. A poorly managed small warehouse may also lead to medicines deteriorating, being stolen or being dispatched in error, posing a threat to public health. Therefore, even if you have only a small warehouse and a few staff, you still need to establish a complete Quality Management System (QMS), including a compliant premises layout (functional zoning), temperature and humidity controls and records, security measures, written SOPs, complete record-keeping and staff training.
Q188 · 在仓库内是否可以使用无线网络（Wi-Fi）？在使用上有什么安全考量？独立链接
Wi-Fi is now widely used in modern medicine warehouses, for example, to connect handheld scanners, mobile terminals and temperature and humidity sensors. Its use is permitted, but its security and reliability must be fully considered. First, **cybersecurity** is a primary concern. The warehouse Wi-Fi network must be encrypted (using at least WPA2 or a higher encryption standard) and protected with a complex administrator password. The guest Wi-Fi network for employees’ personal devices should be physically or logically segregated from the internal production Wi-Fi network used to operate critical systems such as a WMS. Second, **signal coverage and reliability**: ensure that the Wi-Fi signal provides stable, uninterrupted coverage in all operational areas requiring wireless connectivity. A professional site survey should be carried out during planning and installation. Finally, procedures should be in place to manage access by wireless devices and prevent unauthorised devices from connecting to the internal network.
Q189 · 什么是“良好仓储规范”（Good Storage Practice, GSP）？它和GDP是什么关系？独立链接
“Good Storage Practice” (GSP) is a set of guidelines focused on ensuring the quality and integrity of medicines during storage. It sets out detailed requirements for the design, equipment, procedures and personnel of medicine warehouses, covering every storage stage from receipt of medicines to storage and dispatch. GSP can be regarded as a core component of “Good Distribution Practices” (GDP). GDP has a broader scope: it encompasses all the storage activities covered by GSP and extends to other aspects of medicine distribution, such as order processing, transportation, record-keeping, recalls, and the management of customers and suppliers throughout the supply chain. Therefore, full compliance with GDP requirements necessarily means that GSP requirements are also met. In Hong Kong, the official guidance issued by the Department of Health is GDP, the statutory standard that licensed wholesalers must follow.
Q190 · 如果我租用的仓库是与其他公司共享的，这是否被允许？独立链接
Using a multi-tenant warehouse to operate a pharmaceutical wholesale business is permitted, but it presents additional compliance challenges that must be managed strictly. First, your licensed pharmaceutical storage area must be a physically independent and securely segregated unit, such as a caged area with its own lockable door or a separate room. You must have full control over access to the area and prevent employees or goods belonging to other companies from entering. Second, you must clearly define the scope covered by your licence to the Department of Health and mark it clearly on the floor plan. There must be clear agreements with the warehouse owner or other tenants on the management responsibilities and hygiene standards for shared common areas, such as loading platforms and corridors, and these must meet basic GDP requirements, such as cleanliness and pest control. You must demonstrate that the activities of other tenants, such as storing food or ordinary goods, will not create cross-contamination or security risks for your pharmaceutical storage environment.