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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Thematic illustration for pharmaceutical licensing business queries and document organisation services — Discuss actual operating questions one-to-one to clarify the next decision.

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.

📘 Regulatory basis

Emergency lighting is primarily a fire safety requirement governed by the Fire Services Ordinance and relevant building regulations. From a GDP perspective, premises that cannot be operated safely in an emergency are non-compliant. Adequate lighting is essential for accurate operations and preventing errors.

📗 Drew Tang's recommendations

We recommend that clients install emergency lighting compliant with fire safety requirements along all main corridors, work areas, stairwells and exits. The lights should be installed and inspected annually by a registered fire service installation contractor. For critical work areas, consider installing backup lighting connected to an emergency generator or UPS to maintain the ability to operate during a prolonged power outage.

📕 Risk notice

Missing or defective emergency lighting is not only a fire safety breach but also a serious safety hazard. Imagine the lighting suddenly failing completely in a warehouse full of goods: employees could lose their way in the dark, collide with goods or fall. Department of Health and Fire Services Department officers will check that emergency lighting works effectively, and defective lights must be replaced immediately.

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.

📘 Regulatory basis

Good Distribution Practice (GDP) requires “written procedures for the operation, cleaning and maintenance of critical equipment that may affect the quality of medicines”. This makes clear the need to establish SOPs for critical equipment.

📗 Drew Tang's recommendations

SOPs should not be complex, difficult-to-understand lengthy documents. We recommend that clients prepare a concise “operating instruction card” for each piece of equipment, with text and illustrations, and display it beside the equipment for operators to consult at any time. The full SOP should be retained as a formal document for training and audits. For example, the SOP for a temperature and humidity meter can be very simple, but it must exist.

📕 Risk notice

During an inspection, if an officer points to a key piece of equipment and asks the operator how to use it, but the operator cannot answer, or the officer asks to see the equipment’s SOP and you cannot provide it, this will indicate serious deficiencies in your documentation system and training. The officer may question your ability to manage your facilities in a controlled manner.

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.

📘 Regulatory basis

This is mainly regulated by the Buildings Ordinance (Cap. 123). No part of a building may bear a load in excess of its design standard. The Buildings Department has the power to investigate and take enforcement action in respect of buildings suspected of being overloaded. If Department of Health officers have concerns about the structural safety of a warehouse during an inspection, they may also require you to provide relevant evidence.

📗 Drew Tang's recommendations

Consider load-bearing capacity before signing a lease and planning the racking layout. This is particularly important in some older industrial buildings, whose original design load capacity may be low. Although engaging a structural engineer to conduct an assessment will cost money, it is a necessary investment to ensure safe and compliant long-term operations and avoid more serious structural risks and legal problems in the future.

📕 Risk notice

Overloading a warehouse floor is extremely dangerous and may cause cracking, deformation or even collapse, resulting in catastrophic casualties and property damage. If you cannot provide any evidence of the floor’s load-bearing capacity but have installed dense, heavy-duty shelving, the regulatory authority may reasonably question the safety of your operations and prohibit use of the premises until you provide a satisfactory engineer’s report.

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.

📘 Regulatory basis

Good Distribution Practice (GDP) applies to all entities holding a wholesale dealer licence, and its provisions do not provide any exemption based on company size. The Department of Health applies uniform inspection standards.

📗 Drew Tang's recommendations

For small businesses, the key to implementing GDP is to be “proportionate” and “effective”. Your SOPs can be simpler and your record-keeping system more basic (for example, using paper records initially rather than an expensive WMS), but “small as it may be, it must still have all its essential parts”: all core GDP elements must be reflected in your operations. For example, even a small quarantine area must be physically segregated. Rengangyongsheng (Hong Kong) Limited specialises in helping start-ups and small businesses establish GDP-compliant systems in the most cost-effective way.

📕 Risk notice

“My company is small, so the standards can be lower” is a fatal misconception. Applying for a licence with this mindset carries a very high risk of failure. The Department of Health will not lower its standards because you are a start-up. Any compromise on key compliance points, such as failing to keep temperature and humidity records or failing to quarantine non-conforming goods, will be treated as an unacceptable deficiency.

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.

📘 Regulatory basis

The GDP annex on computerised systems requires systems to be secure. If a Wi-Fi network forms part of your computerised system, ensuring its security is a compliance requirement to protect data integrity and confidentiality and prevent unauthorised access and tampering.

📗 Drew Tang's recommendations

We recommend that clients use an enterprise-grade wireless networking solution rather than a home wireless router. Enterprise-grade APs (Access Points) offer stronger security, better roaming performance and centralised management. Regularly changing the Wi-Fi password and promptly revoking access for departing staff are basic network security hygiene.

📕 Risk notice

An open Wi-Fi network with no password is a significant security vulnerability. It could allow outsiders to access, tamper with or attack your WMS, pharmaceutical inventory data or even temperature and humidity monitoring systems. If an inspection reveals obvious gaps in your network security, the reliability of your data will be seriously questioned, undermining confidence in your entire management system.

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.

📘 Regulatory basis

In Hong Kong, the standard directly cited in laws and regulations is Good Distribution Practice (GDP). International bodies such as the World Health Organization (WHO) also publish separate Good Storage Practice (GSP) guidelines. Their content overlaps substantially with the warehousing provisions of GDP, making them an important technical reference.

📗 Drew Tang's recommendations

As an applicant, you should focus on understanding and implementing the GDP guidance issued by the Hong Kong Department of Health. There is no need to look for a separate GSP document to study. If you implement all GDP provisions on premises, equipment, storage and handling of materials, your warehousing practices will naturally meet the GSP standard. The quality systems we help clients establish are based on Hong Kong GDP.

📕 Risk notice

Do not be confused by the term GSP and assume that it is another set of standards that must be met independently. Under Hong Kong’s regulatory framework, your compliance target is GDP. If a consultant or supplier talks only about GSP and has little understanding of the broader GDP requirements, you should question whether they have the expertise to cover the full scope of the licence application.

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.

📘 Regulatory basis

GDP requires licence holders to have sufficient control over their licensed premises. In a shared environment, you must demonstrate to the Department of Health that you have absolute and exclusive control over your dedicated medicine storage area, and have measures in place to manage risks arising from the shared environment.

📗 Drew Tang's recommendations

If you choose to use a shared warehouse, we strongly recommend that you clearly define your dedicated area and each party’s responsibilities for managing common areas in the lease. When applying for a licence, proactively submit a risk assessment report to the Department of Health analysing the risks that may arise from the shared environment (such as security, pests and contamination) and setting out in detail the control measures you will take. This proactive and transparent approach will increase the regulator’s confidence.

📕 Risk notice

The worst-case scenario is simply marking out an open corner in a shared warehouse to store medicines, which is absolutely not permitted. You cannot prevent anyone from accessing your medicines or control the surrounding environment. If other tenants in the shared warehouse have very poor hygiene, causing a pest infestation throughout the building, your licence application may still be refused because of excessive external environmental risks, even if the management of your own independent unit is excellent.

Q191 · 仓库的通风系统有什么要求？是否需要安装新风系统？独立链接

A medicine warehouse ventilation system is important for maintaining suitable storage conditions and staff health. The basic requirement is to ensure air circulation and avoid dead spots or stagnant air. This helps maintain uniform temperature and humidity throughout the warehouse and remove any odours or volatile gases that may accumulate. For most warehouses storing only ordinary packaged medicines, good natural or mechanical ventilation (such as exhaust fans) is generally sufficient. However, if your warehouse is fully enclosed with no windows, or if the medicines you store release dust or volatile organic compounds (VOCs), installing a fresh air system capable of supplying fresh, filtered air becomes essential. This not only improves air quality but can also create positive indoor pressure, reducing the entry of external contaminants.

📘 Regulatory basis

Good Distribution Practice (GDP) requires storage areas to have adequate ventilation to maintain suitable storage conditions. Although it does not require a fresh air system, the regulatory principle is that you must demonstrate that your ventilation measures are adequate to protect the quality of medicines and the health of staff.

📗 Drew Tang's recommendations

When designing a warehouse, we recommend assessing ventilation requirements under the worst-case scenario. Even if you do not currently store special medicines, it is prudent to allow space and duct routes for installing a fresh air system in view of possible future business development. Good ventilation may even be mandatory in areas where operations such as relabelling are carried out, to protect operators from inhaling potential solvents or dust.

📕 Risk notice

A completely enclosed, poorly ventilated warehouse with a noticeable odour cannot pass a Department of Health inspection. This poses a risk to the storage of medicines and also breaches relevant occupational safety and health requirements. If officers feel unwell in the warehouse or find dust in the air, your premises may be deemed unsuitable for pharmaceutical operations.

Q193 · 如果我的业务只做药品转口贸易，货物不进入香港境内，是否还需要在香港设立符合GDP的仓库？独立链接

This is a very common and important question. The answer is: quite possibly. According to Department of Health guidance, if one legal entity (for example, the holding company of your clinic group) centralises procurement for multiple separate legal entities (for example, each clinic is a separate limited company) and then “distributes” or “resells” the pharmaceutical products to those clinics, the holding company’s activities constitute “wholesale”. The holding company would therefore need to apply for a wholesaler licence and establish a central pharmaceutical products warehouse that meets GDP standards. However, if all the clinics belong to the same legal entity (that is, they are branches rather than separate subsidiaries), the transfer of pharmaceutical products between different locations within the same entity may not be regarded as wholesale. The key factors are the legal structure and the transfer of ownership of the pharmaceutical products. Even internal transfers must ensure that transport and storage meet pharmaceutical product quality requirements.

📘 Regulatory basis

The Import and Export Ordinance (Cap. 60) and the Pharmacy and Poisons Ordinance (Cap. 138) jointly define the regulatory scope for the import, export and possession of medicines. Pure trans-shipment cargo may be exempt from import licensing under specific conditions.

📗 Drew Tang's recommendations

Even if you are engaged in re-export trade, we recommend establishing a documented Quality Management System to record and demonstrate that your medicines are handled appropriately throughout the supply chain. This includes selecting compliant transport and warehousing partners and retaining all relevant temperature records and transport documents. This is not only good business practice; it can also demonstrate your professionalism when overseas partners or regulatory authorities make enquiries.

📕 Risk notice

“Transhipment” and “import followed by re-export” must be clearly distinguished. If medicines have at any point left the customs-controlled area and entered any warehouse in Hong Kong (even temporarily), this constitutes “import”. Once an import has taken place, you must hold a Wholesale Dealer Licence, and the warehouse must also be licensed premises that comply with GDP. Confusing the two may lead to you unknowingly breaching the law by dealing in medicines without a licence.

Q194 · 对于需要销毁的药品，除了委托专业公司，我自己是否可以进行销毁？独立链接

Absolutely not. In Hong Kong, no individual or company may destroy medicines themselves, particularly expired or non-conforming medicines classified as chemical waste. Self-disposal (for example, throwing medicines in the rubbish, flushing them down the toilet or burning them) is a serious offence. The correct approach is to treat these medicines as chemical waste and have them handled by a professional company holding a valid chemical waste disposal licence issued by the Environmental Protection Department. The process must be fully documented using a “Trip Ticket” to track the waste from your warehouse to its final disposal facility. This requirement not only protects the environment, but also prevents destroyed medicines from being unlawfully collected and re-entering the illegal market, where they could endanger public health.

📘 Regulatory basis

The Waste Disposal (Chemical Waste) (General) Regulation expressly stipulates how producers of chemical waste must package, label, store and dispose of that waste. Disposing of chemical waste yourself breaches the Regulation and may result in legal penalties.

📗 Drew Tang's recommendations

We recommend that clients treat medicines destruction as a formal process requiring strict document control. Before destruction, prepare a detailed destruction list covering the medicine name, batch number, quantity and reason for destruction. The list should be approved by the quality department. After destruction, file the certificate of destruction provided by the licensed disposal company together with the relevant transport records to create a complete destruction record pack.

📕 Risk notice

Do not assume that you can dispose of expired medicines through unofficial channels. The Environmental Protection Department enforces the rules very strictly. Furthermore, if your expired medicines are found circulating illegally on the market because they were disposed of improperly, you, as the source, will face extremely serious legal liability and reputational damage, and may even have all relevant licences revoked.

Q195 · 仓库内是否需要划分一个专门的区域用于药品的取样操作？独立链接

Yes, if your business involves sampling medicines for quality control, you must set up a dedicated, environmentally controlled sampling room or booth (Sampling Booth/Room). Sampling is a high-risk operation because it requires the original medicine packaging to be opened, creating a high risk of microbial or cross-contamination. The design and management of the sampling room must therefore be very stringent. Ideally, it should be a laminar-flow cabinet fitted with a high-efficiency particulate air filter (HEPA filter), or a separate cleanroom, to provide a sterile or low-dust working environment. Personnel entering the sampling room must wear clean workwear, gloves and masks. All sampling tools must be sterile and used for only one batch per sampling operation. The entire sampling process must be guided by detailed SOPs and recorded.

📘 Regulatory basis

Sampling falls within the scope of Good Manufacturing Practice (GMP) because it directly affects product quality. GMP sets out detailed requirements for the sampling environment, personnel and procedures, with the aim of “preventing contamination and cross-contamination during sampling”.

📗 Drew Tang's recommendations

For most pharmaceutical wholesalers, their business does not involve sampling finished medicines in sealed packaging. Sampling usually takes place during medicine manufacture or the acceptance of raw materials. If you only distribute finished products, you will generally not need a sampling room. However, if you need to open packages for any form of inspection beyond visual inspection, we strongly recommend seeking our advice first to determine whether this would be considered sampling requiring GMP-level controls.

📕 Risk notice

Opening medicine packaging or taking samples for ‘inspection’ in an ordinary warehouse environment is strictly prohibited and constitutes a serious breach. This directly compromises the sterility or integrity of the medicine, making it unsuitable for sale. If the Drug Office discovers this, the batch will be regarded as contaminated, and your company may be investigated for suspected unlawful ‘manufacturing’ because the product’s condition has been altered.

Q196 · 处所的地址变更是否需要重新申请牌照？流程是怎样的？独立链接

Yes, a pharmaceutical wholesaler licence is tied to a specific premises address. If you plan to move your warehouse or office to a new address, this is considered a major change. You must apply to the Drug Office, Department of Health, to change the licensed premises, and will generally need to undergo an approval process similar to that for a new application. The process is broadly as follows. First, submit a written application to the Department of Health explaining the reason for the change and providing details of the new premises, including the tenancy agreement and a detailed layout plan. Secondly, the new premises must be fully fitted out and equipped in accordance with GDP requirements. Once preparations are complete, notify the Department of Health, which will arrange a new site inspection. The Department of Health will approve the change-of-address application and issue a new licence showing the updated address only after the new premises have passed inspection and been confirmed as fully meeting all GDP requirements.

📘 Regulatory basis

Under the Pharmacy and Poisons Regulations, any change to licensed premises must be approved by the Pharmacy and Poisons Board. Pharmaceutical wholesale business must not be conducted at the new address before approval is granted.

📗 Drew Tang's recommendations

We strongly recommend that clients begin planning a relocation at least 6-9 months before the current lease expires. The entire process, from selecting a site and fitting it out to submitting an application and passing the final inspection, takes a long time. Be sure not to terminate the licence for the old premises before the new licence is approved, to ensure business continuity. We can help clients manage the entire relocation and licence change process to ensure a seamless transition.

📕 Risk notice

Moving to a new address and commencing operations without first obtaining formal approval from the Department of Health constitutes unlicensed operation and is a serious offence. This may result in your licence being suspended or revoked, and criminal prosecution. Similarly, terminating the lease for your existing premises before the new premises have passed inspection may leave your business without compliant operating premises and bring operations to a halt.

Q197 · 对于列载毒药销售商（俗称“药行”），其处所和仓储要求与批发商有何不同？独立链接

A Listed Seller of Poisons (LSP) operates from a shop serving the public (a “drug store”). Its storage requirements differ in scale and layout from those of a wholesaler’s bulk warehouse, but the core principles are the same. The main differences are: 1. **Functional zoning**: The front of the drug store is the retail area, while the rear or an upper floor is used for storage. Clear zoning is still required. For example, prescription medicines must be kept in a “non-sale area” (dispensary) inaccessible to the public, while controlled poisons (such as Schedule 1 poisons) must be kept in locked cabinets or drawers. 2. **Storage quantities**: A drug store holds far less stock than a wholesaler, so its storage area is smaller. It must still be clean and orderly, and medicines must not be placed directly on the floor. 3. **Serving the public**: As the business serves members of the public directly, the overall environment, lighting and hygiene must be of a high standard to create a professional and reliable impression. 4. **Display of poisons**: Schedule 2 poisons may be displayed at the front of the shop, but must be kept where customers cannot reach them (for example, behind the counter). In short, although the premises are smaller, the requirements for storage by category, secure custody and prevention of mix-ups are equally strict.

📘 Regulatory basis

The Pharmacy and Poisons Regulations set out specific requirements for the premises of Listed Sellers of Poisons, such as keeping poisons separate from non-medicinal products and mandatory requirements for storing Schedule 1 poisons under lock and key.

📗 Drew Tang's recommendations

For clients planning to open a drug store, we recommend taking medicine segregation and storage requirements into account from the design stage. A well-designed “non-sale area” will not only meet compliance requirements but also improve the efficiency of the pharmacist or dispenser. Placing the poison cupboard used to store controlled medicines within the coverage of CCTV is a good way to strengthen security.

📕 Risk notice

The most common breaches by medicine shops are placing medicines that require a prescription or supervised sale on open shelves for customers to take freely, or failing to keep Schedule 1 poisons properly locked away. These acts may result in suspension or revocation of the licence because they directly endanger public safety in the use of medicines.

Q198 · 仓库内是否允许进行药品的二次加工，例如将大包装分拆为小包装？独立链接

Under a pharmaceutical products wholesaler licence, **any form of secondary processing is strictly prohibited**, including breaking down bulk packs of pharmaceutical products into smaller packs. Such repackaging is regarded as part of the “manufacturing” process because it changes the original packaging and labelling of the pharmaceutical products and introduces a very high risk of contamination and errors. To carry out such operations, you must apply separately for a Manufacturer’s Licence, and the operations must take place in a cleanroom that complies with Good Manufacturing Practice (GMP) standards. Even a well-managed ordinary pharmaceutical warehouse falls far short of the cleanliness, temperature and humidity, and air quality standards required for open handling of pharmaceutical products.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance defines “manufacture” broadly to include “assembling, packing and labelling”. Any unauthorised manufacturing activity is unlawful. A wholesale dealer licence is strictly limited to “sale, distribution and storage” and does not cover any form of processing or repackaging.

📗 Drew Tang's recommendations

If you have a commercial need to repackage medicines, the correct route is to engage a licensed pharmaceutical manufacturing facility (Licensed Pharmaceutical Manufactory) holding the relevant Manufacturer Licence to carry out the repackaging for you. Do not attempt to “DIY” this in your own wholesale warehouse; this is an absolute legal boundary.

📕 Risk notice

Unauthorised splitting of medicine packs in a wholesale warehouse is one of the serious breaches least tolerated by the Department of Health in its enforcement work. This is regarded as illegal manufacture of medicines. If discovered, you will not only lose your Wholesale Dealer Licence; the company and the responsible person will also face severe criminal prosecution, which may result in substantial fines and imprisonment. This is an absolute red line that must not be crossed.

Q199 · 对于中药材批发商，其仓库在防潮、防霉、防蛀方面有何特殊要求？独立链接

Because of their natural plant or animal origins, Chinese herbal medicines are more sensitive than chemical medicines to humidity and pests in storage and therefore require more specific and stringent protection against damp, mould and infestation. First, **humidity control** is paramount. The warehouse must be equipped with powerful dehumidifiers and humidity must be monitored continuously to ensure that relative humidity is kept at a low level (typically, 45%-65% is recommended, depending on the type of Chinese herbal medicine). Second, **temperature control** is also important. High temperatures and humidity provide ideal conditions for mould and pests, so good ventilation and air-conditioning systems are also needed. Third, **regular inspections**. A frequent stock inspection plan must be established and implemented, with the Chinese herbal medicines turned and checked regularly, particularly those prone to infestation or mould, for mould, insect damage, discolouration or unusual odours. Fourth, **physical segregation**. Different batches of Chinese herbal medicines, those likely to transfer odours (such as mint and sandalwood), and those prone to infestation (such as angelica and goji berries) should be stored separately. All Chinese herbal medicines must be stored off the floor and away from walls to allow ventilation.

📘 Regulatory basis

The Guidelines on Good Practice for Wholesalers of Chinese Herbal Medicines, issued by the Chinese Medicine Council of Hong Kong, clearly specify storage requirements for Chinese herbal medicines, emphasising the importance of preventing dampness, mould and pests, and requiring effective controls over the temperature and humidity of the storage environment.

📗 Drew Tang's recommendations

We recommend that Chinese herbal medicine warehouses invest in commercial air-conditioning and dehumidification systems with humidity control. For high-value, highly perishable herbs such as cordyceps and bird’s nest, consider using dedicated temperature- and humidity-controlled cabinets or separate refrigerated facilities. Storing herbs that readily absorb moisture or odours in airtight containers (such as food-grade plastic boxes or metal tins) is also an effective measure.

📕 Risk notice

Once Chinese herbal medicines become mouldy or infested with insects, their quality and safety are seriously compromised, and they may contain highly toxic substances such as aflatoxins. They must not be used for sale or dispensing. If an inspection finds that your warehouse is damp or smells mouldy, or that there are live insects or mould on the Chinese herbal medicines, your licence application may be refused and you may be required to destroy all existing stock, resulting in significant losses.

Q202 · 递交香港药牌申请时，如何正确填写申请表格并准备随附文件？独立链接

Submitting an application is the formal start of the entire process, and its accuracy and completeness directly affect the progress of the approval process. Download the latest application form from the Drug Office, Department of Health website (for example, Form B for a Wholesale Dealer Licence). When completing it, ensure that all information, particularly the company name, address, directors and persons in charge, exactly matches your Business Registration Certificate (BR) and Certificate of Incorporation (CI). Even minor discrepancies may lead to a request for further information. The accompanying documents usually include company registration documents, the Business Registration Certificate, a premises layout plan for the proposed medicine warehouse (showing functional areas in detail), CVs and proof of qualifications for the person in charge and their deputy, and copies of identification documents for the company directors. All documents must be certified as required and collated for review by the officers.

📘 Regulatory basis

The Department of Health’s application guide clearly lists the forms and documents to be submitted. Under the Pharmacy and Poisons Regulations, applicants are responsible for providing true, accurate and complete information. Any false statement may result in the application being refused and may even give rise to legal liability.

📗 Drew Tang's recommendations

RGYS may assist with document preparation and project coordination within the written scope of services; the respective responsible parties must verify personnel qualifications and statutory roles and take responsibility for professional judgements, while approval is determined independently by the competent authority. Experience shows that attention to detail determines success or failure. We will provide you with a customised document checklist and review all the materials you prepare item by item to ensure that their format and content are entirely correct. In particular, we will engage a professional drafter to prepare the premises plans, clearly marking the goods receiving area, storage area, returns area, office and other areas, giving reviewing officers a professional and meticulous first impression.

📕 Risk notice

The most common causes of delay are incomplete documents or inconsistent information. For example, the experience described in the responsible person's CV may not be relevant to pharmaceutical wholesale, or the premises layout plan may be too basic to reflect the actual layout. These seemingly minor issues may prompt the Drug Office to issue a request for further information, extending the entire approval process by weeks or even months.

Q209 · 如果我的申请需要进行负责人（RP）面试，面试通常会涉及哪些内容？独立链接

Although not all applications require a formal interview for the Responsible Person (RP), an interview may be requested in certain circumstances, for example, if the PPB has doubts about the RP’s experience or understanding of the regulations. The main purpose is to assess whether the RP genuinely has the ability and knowledge needed to supervise the licensed business. The interview will generally cover the following areas. First, understanding of Hong Kong pharmaceutical legislation, particularly the Pharmacy and Poisons Ordinance and relevant codes of practice. Second, the RP’s role and responsibilities in the Quality Management System (QMS), such as handling product complaints and initiating and conducting medicine recalls. Third, scenario questions may be used to test the RP’s ability to respond and make decisions in unexpected situations, such as abnormal warehouse temperature or humidity or an accident during transport. The interviewer will want to confirm that the RP is not merely a nominal person in charge but a professional with practical management ability.

📘 Regulatory basis

The Code of Practice for Wholesale Dealers expressly requires a licence holder to appoint a person-in-charge with appropriate authority and resources to discharge their duties and ensure the quality of medicines. An interview is one way for the PPB to verify whether that person is “fit and proper”.

📗 Drew Tang's recommendations

If you receive an interview notice, we will immediately begin an intensive interview coaching programme for your RP. A senior consultant from Rengangyongsheng (Hong Kong) Limited will conduct a one-to-one mock interview, covering all questions that may be asked and refining the RP's answers to ensure they are clear, logical and confident, and demonstrate convincing professional competence to the Committee.

📕 Risk notice

Poor performance by the RP at interview is one of the direct reasons an application may fail. If the RP has only a superficial understanding of key regulations, or makes incorrect judgements in scenario-based questions, the Committee will have good reason to consider them incapable of fulfilling the role and reject the entire licence application. The interview must therefore be taken seriously and prepared for as the most critical stage.

Q211 · 申请中药材零售商牌照和申请西药批发商牌照在流程上有什么主要区别？独立链接

Although both Chinese herbal medicine retail licences and Wholesale Dealer Licences are administered by the Department of Health, they fall under different departments, with significantly different approval processes and areas of focus. First, the regulatory authorities differ: Chinese medicine licences are handled by the Chinese Medicine Regulatory Office (CMRO), while Western medicine licences are handled by the Drug Office (DPO). Second, personnel requirements differ: Chinese medicine retailers must employ a sufficient number of qualified Chinese medicine practitioners according to the shop’s size, such as Chinese herbal medicine dispensers or Chinese medicine dispensers, whereas Western medicine wholesalers must appoint an RP. Third, premises requirements differ: Chinese herbal medicine retail shops need designated areas for displaying, storing and dispensing Chinese herbal medicines, and must comply with the storage guidance in the Hong Kong Chinese Materia Medica Standards; Western medicine wholesale warehouses place greater emphasis on temperature and humidity control, security and logistics management. Finally, the governing legislation differs: the former is mainly governed by the Chinese Medicine Ordinance (Cap. 549), while the latter is governed by the Pharmacy and Poisons Ordinance (Cap. 138).

📘 Regulatory basis

The Chinese Medicine Ordinance (Cap. 549) and its subsidiary legislation provide the main legal framework for licensing Chinese medicine traders. The Pharmacy and Poisons Ordinance (Cap. 138) and its subsidiary legislation provide the legal basis for regulating Western medicine distributors.

📗 Drew Tang's recommendations

We recommend that clients clearly define their business model before deciding which application to pursue. Rengangyongsheng (Hong Kong) Limited has extensive experience handling both types of licence application and can tailor an application strategy to your specific business (retail or wholesale, Chinese medicine or Western medicine), helping you avoid going down the wrong path by confusing the requirements of the two systems.

📕 Risk notice

The greatest risk is “mixing things up” by preparing a Chinese medicine licence application using the approach for a Western medicine licence, or vice versa. For example, equipping a Chinese medicine shop with an expensive, comprehensive air-conditioning system while overlooking the requirement to store products according to the characteristics of Chinese medicines. This mismatch in understanding can result in numerous non-compliances during the on-site inspection and lead to application failure.

Q212 · 如果我的公司计划同时经营药品和医疗器械，申请流程有何不同？独立链接

This is an excellent question and demonstrates forward-thinking about business expansion. In Hong Kong, medicines and medical devices are governed by two separate regulatory systems. Medicines 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 regulates medical devices through a voluntary listing system 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 therefore need to submit a separate application to the MDD to demonstrate that your company meets the requirements of the Code of Practice for Importers and Distributors under the Medical Device Administrative Control System, including establishing a Quality Management System (such as ISO 13485). The two application processes run in parallel and do not affect each other, but you must satisfy two different sets of regulations and standards.

📘 Regulatory basis

Medicines are regulated under the Pharmacy and Poisons Ordinance. Medical devices are regulated under the guidelines and codes of the Medical Device Administrative Control System (MDACS). Mandatory registration will be introduced when the Medical Devices Ordinance comes into force.

📗 Drew Tang's recommendations

We recommend that you manage the two applications as separate projects. Rengangyongsheng (Hong Kong) Limited can handle medicines licence applications and provide end-to-end consultancy services for medical device listing. We can help you establish an integrated quality management system that meets the GSP (Good Distribution Practice) requirements for medicines and the ISO 13485 standard for medical devices, delivering an efficient “one system, two licences” management model.

📕 Risk notice

The risk lies in confusing the two sets of quality management requirements. For example, it would be wrong to assume that the temperature and humidity recording method used in pharmaceutical warehouses is entirely suitable for all medical devices. Some medical devices have specific requirements for electrostatic control or light exposure. If these are not reflected in the SOPs, they may be identified as serious deficiencies during an MDD audit or later inspection, affecting your business reputation.

Q217 · 我是否可以在租赁商业办公室的同时，将其一部分用于药品储存以申请牌照？独立链接

This is a common question. Under Hong Kong’s Import and Export Ordinance, if your business consists solely of pharmaceutical product trans-shipment—that is, goods are shipped from one country or region, transhipped in Hong Kong (for example, by changing means of transport in a restricted area at the airport or port), and then continue to another country or region, without leaving the area under Hong Kong Customs control—those goods are not regarded as having been “imported” into Hong Kong. Under this narrowly defined trans-shipment model, you may need to register a company in Hong Kong to conduct business, but you would not generally need to establish your own physical warehouse in Hong Kong that meets GDP standards, because the pharmaceutical products do not enter Hong Kong’s commercial distribution chain. However, you must still ensure that storage and handling during trans-shipment meet GDP requirements in the country of origin, the destination country and during transport.

📘 Regulatory basis

The Code of Practice for Wholesale Dealers is the key reference for premises requirements. It expressly states that “the design and layout of the premises must minimise the risk of cross-contamination and mix-ups” and requires “adequate security measures to prevent unauthorised access”.

📗 Drew Tang's recommendations

We generally recommend that clients choose dedicated industrial buildings or commercial buildings with warehouse areas. If you do wish to adopt a “commercial office plus warehouse” model, we strongly recommend that you ask us to conduct a detailed site survey and feasibility assessment before signing the lease. We will assess the feasibility of physical separation, the building facilities' capacity to support your needs and the associated modification costs, and provide you with a clear, evidence-based recommendation.

📕 Risk notice

The greatest risk is investing heavily in fitting out premises only to be told during an on-site inspection that the physical segregation is non-compliant or prohibited by the building's deed of mutual covenant. For example, glass partitions or half-height wire-mesh fencing alone may well be considered inadequate segregation. In this situation, your entire investment would be wasted and the application could be deadlocked.

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