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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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.

Q192 · 卫生署在视察后，可能会发出哪些类型的缺陷（Deficiency）？如何应对？独立链接

After the site inspection, the Department of Health’s inspection report will usually classify findings (deficiencies) into three levels, in ascending order of severity: 1. **Other**: The least serious level, usually covering observations or recommendations that do not directly breach GDP but indicate room for improvement. 2. **Major**: A deficiency involving failure to comply with GDP principles that may result in medicines not being handled in accordance with their approved conditions, or pose a potential risk to patients, but is not life-threatening. Examples include missing temperature and humidity records for some periods, or incomplete cleaning records. 3. **Critical**: The most serious level, referring to a deficiency that may threaten patients’ lives or cause serious harm to health, or involve fraud, falsification or similar conduct. Examples include finding expired medicines in the released goods area, a complete break in the cold chain, or falsified records. The response should be as follows: on receipt of the report, you must submit a written corrective and preventive action plan (CAPA Plan) within the specified period (usually 1–2 weeks), explaining in detail how you will correct the deficiencies identified and what measures you will take to prevent them from recurring.

📘 Regulatory basis

The classification and handling procedures for deficiencies are based on internationally accepted pharmaceutical regulatory principles, such as the guidance of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The Department of Health’s inspection and assessment standards are consistent with these international standards.

📗 Drew Tang's recommendations

Treat any deficiencies identified seriously and constructively. The key to writing a CAPA report is “Root Cause Analysis”; do not stop at the surface-level problem. For example, if expired medicines are found, the root cause may not be staff carelessness but the lack of an expiry alert function in the WMS. A thorough CAPA report can demonstrate your management commitment and capability to the Department of Health. Rengangyongsheng (Hong Kong) Limited has extensive experience assisting clients in responding to inspection deficiencies.

📕 Risk notice

A “critical” deficiency will almost certainly result in your licence application being refused or your existing licence being suspended until you complete remediation and pass a follow-up inspection. Several “major” deficiencies may also accumulate to produce the same result. Ignoring an inspection report or responding to it perfunctorily will be regarded as contempt for the regulator and may lead to more serious consequences.

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.

Q200 · 场地视察时，我是否可以拒绝回答视察官员的问题或拒绝其进入某些区域？独立链接

Absolutely not. Under Hong Kong law, authorised Department of Health inspectors have statutory powers to enter and inspect any licensed premises or premises for which a licence application has been made while carrying out their duties. As a licence applicant or licensee, you are legally obliged to cooperate with inspections. Refusing to allow an officer to enter any part of the premises, refusing to answer questions about business operations, or refusing to provide documents requested for inspection constitutes “Obstruction”, a serious criminal offence. Your attitude towards cooperation is an important consideration during an inspection. A cooperative, transparent and professional attitude can support your application. Conversely, any form of obstruction, concealment or provision of false information will arouse the officers’ suspicions and may lead to the most serious legal consequences.

📘 Regulatory basis

Section 28 of the Pharmacy and Poisons Ordinance (Cap. 138) expressly confers on authorised officers the power to enter and inspect premises, inspect and copy documents, and take away samples. Section 29 of the Ordinance expressly provides that any person who “wilfully obstructs or impedes” an authorised officer in the execution of their duties commits an offence.

📗 Drew Tang's recommendations

We recommend that clients train all relevant employees before an inspection and tell them to fully cooperate with the inspectors. Appoint a senior manager (such as the quality manager or person responsible for the company) as the main escort and contact person to guide the inspection and answer questions. If unsure about an answer, staff may politely say that they need to check the information before responding, but must not refuse to answer outright. Open and honest communication is key.

📕 Risk notice

The consequences of obstructing enforcement are far more serious than being found to have a few “major deficiencies”. It will not only lead to the immediate refusal of your licence application or revocation of an existing licence, but will almost certainly result in criminal prosecution. A conviction will leave a criminal record and cause irreparable harm to the future prospects of the company and individuals. This is an absolute line that must not be crossed when dealing with the regulator.

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