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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Q361 · 如果我们的持牌处所需要搬迁或进行大规模翻新，应该怎么办？独立链接
The address and layout of licensed premises are key considerations in the licensing assessment, and any changes must be approved in advance by the Department of Health. If you plan to relocate or carry out major renovations to the existing premises (for example, changing the structure of a storage area or increasing or reducing the floor area), you must submit a written application to the Drug Office, Department of Health in advance. The application should include detailed plans of the new premises, renovation plans and the reasons for the changes. The Department of Health will assess whether the new premises or layout continues to meet the licensing conditions, particularly the requirements for drug storage and security. You must not handle any drugs at the new or renovated premises before formal approval has been obtained from the Department of Health. After approval, the Department of Health will generally arrange an on-site inspection to confirm that everything complies with the plans and requirements before updating your licence details.
Q362 · 我们的“负责人”（Responsible Person）离职了，对牌照有影响吗？需要做什么？独立链接
The “Person-in-Charge” is a key position at a licensed wholesaler or manufacturer, responsible for overseeing day-to-day operations to ensure compliance. Their departure has a significant impact on the licence, and you must act immediately. First, you should appoint a new, suitably qualified Person-in-Charge as soon as possible. They should have sufficient pharmaceutical knowledge, industry experience and understanding of the relevant legislation. Second, you must notify the Drug Office, Department of Health in writing within a reasonable time after the personnel change (usually recommended within 14 days), advising that the former Person-in-Charge has left and submitting the new appointee’s detailed CV and proof of qualifications. The Department of Health will assess whether the new appointee meets the requirements. Until a suitable replacement is found, senior management should appoint an interim acting person and ensure that all compliance activities continue without disruption.
Q363 · 卫生署的视察员在检查中发现了一些缺陷（deficiencies），接下来会发生什么？独立链接
At the end of the Department of Health inspection, the inspectors will hold a debriefing meeting with the company’s management and verbally advise them of the preliminary major deficiencies identified. You will subsequently receive a formal inspection report listing all observed deficiencies in writing and classifying them according to their severity (for example, critical, major and other deficiencies). The report will require you to submit a detailed corrective and preventive action plan (CAPA Plan) for each deficiency within a specified period (usually 30 days). The plan must explain how you will correct the current problem (corrective action) and what systematic measures you will take to prevent it from recurring (preventive action). The Department of Health will review your CAPA Plan and, if it considers the plan feasible, require you to implement it. It may follow up on your remediation through document reviews or a further site inspection.
Q364 · 我们是一家中成药制造商，在日常生产中，对原材料（中药材）的检验有什么要求？独立链接
As a licensed manufacturer of proprietary Chinese medicines, quality control of raw materials is the first step in ensuring the safety and efficacy of the finished product, and is a core GMP requirement. Each batch of Chinese herbal medicines purchased must be rigorously tested before being used in production. The tests must include at least: 1. Identification of origin, confirming that the species is correct and that there is no confusion or adulteration. 2. Macroscopic examination, using traditional methods such as visual inspection, touch, smell and taste to check whether the appearance, colour and odour of the medicines conform to pharmacopoeial standards. 3. Microscopic identification, where necessary, using a microscope to examine the tissue structure of the medicines. 4. Physicochemical identification, including tests such as thin-layer chromatography (TLC), with comparison against the chromatogram of the relevant reference standard. 5. Safety testing for harmful substances such as heavy metals, pesticide residues and aflatoxins, to ensure that their levels are within statutory limits. All testing must be supported by detailed records and reports.
Q365 · 什么是“列载毒药销售商”？我们在日常销售中需要注意哪些特殊规定？独立链接
A “Listed Seller of Poisons” (LSP) generally refers to what is commonly known as a “medicine shop” or “drug shop”. They are permitted to sell Part II poisons listed in Schedule 10 to the Pharmacy and Poisons Regulations. These medicines are relatively low-risk, such as certain topical antiseptic solutions and pain-relief balms. In day-to-day sales, you must observe the following special requirements: 1. Medicines must be sold at the registered premises. 2. Medicines must be sold in their original, unopened containers. You may not break up large packs for retail sale. 3. A pharmacist does not need to be present to supervise sales, and purchasers’ details do not need to be recorded. 4. However, you must ensure that medicine labels are clear and comply with regulatory requirements. 5. Most importantly, you must not sell any Part I poisons or unregistered pharmaceutical products.
Q366 · 我们的药品标签或包装说明书内容需要更新（例如增加警示语），这个变更需要向卫生署申报吗？独立链接
Yes, medicine labels and package inserts (also known as “leaflets”) are important parts of a medicine's registration dossier, and any change to their content must be approved by the Department of Health. Whether adding a new warning, updating indications, changing directions for use or dosage, or simply making an artwork change, each is a “change to the particulars of registration” and must go through the formal change application procedure. You will need to submit to the Department of Health an “Application for Change of Particulars of Registered Pharmaceutical Product/Ingredient”, together with a comparison of the old and new labels/leaflets, scientific data or documents supporting the change (for example, the latest clinical study data supporting the addition of a warning), and the reason for the change. You may use the new label or leaflet only after receiving the Department of Health's approval letter.
Q367 · 我们想委托第三方物流公司（3PL）来储存和运输我们的药品，这在合规上有什么要求？独立链接
Outsourcing pharmaceutical-product storage and transport to a third-party logistics company (3PL) is permitted, but this does not mean you can outsource your compliance responsibilities as well. As a licensed wholesaler, you remain ultimately responsible. When selecting and using a 3PL, the following compliance requirements must be met: 1. Due diligence: you must rigorously audit the 3PL to ensure its facilities, equipment, personnel and procedures meet GDP requirements. 2. Technical agreement: you must enter into a detailed Technical Agreement with the 3PL, clearly defining each party's responsibilities and obligations at every stage of pharmaceutical-product handling, including receipt, storage, temperature monitoring, picking, packing, transport, record retention, and complaint and recall handling. 3. Audit rights: you must retain the right to audit the 3PL regularly to ensure ongoing compliance. 4. Department of Health notification: you must notify the Department of Health of the 3PL engaged and the address where it stores your pharmaceutical products.
Q368 · 药品广告的发布受到哪些监管？作为持牌人，我们需要注意什么？独立链接
Hong Kong strictly regulates pharmaceutical advertising to prevent the public from being misled and to ensure that information is accurate. The main regulatory requirements include: 1. It is prohibited to advertise to the public medicines for treating diseases listed in Schedule 1 to the Undesirable Medical Advertisements Ordinance, such as cancer and diabetes. 2. It is prohibited to advertise prescription medicines (Part I poisons) to the public. 3. All pharmaceutical advertisements must be truthful and accurate, and must not contain false, exaggerated or misleading claims. 4. Advertisements must not imply that a medicine can “cure” a condition or is “100% effective”. As a licence holder, you must carefully review the content of any advertisement—including those on television, in newspapers, on websites and on social media—and ensure that it fully complies with the regulations before planning to publish it. Although restrictions on OTC medicine advertising are fewer, it should still be approached responsibly, with balanced information and a recommendation that consumers consult a healthcare professional before use.
Q369 · 我们需要销毁一批过期或不合格的药品，正确的处理程序是怎样的？独立链接
The destruction of expired or non-conforming medicines must be strictly controlled and documented to prevent them from re-entering the market. The correct procedure is as follows: 1. Segregation and records: First, remove the medicines awaiting destruction from normal inventory and place them in a secure area clearly labelled ‘Non-conforming Goods’ or ‘Awaiting Destruction’. At the same time, prepare a detailed destruction list stating the name, batch number, quantity and reason for destruction of each medicine. 2. Select a destruction method: The method must ensure that the medicines cannot be reused. Common methods include incineration, chemical decomposition or solidification in cement. Medicines must never be disposed of directly in ordinary rubbish bins or drains. 3. Engage a qualified company: Destruction should be carried out by a specialist waste-treatment company holding the relevant licence. 4. On-site supervision: During destruction, the licence holder should send a staff member to supervise on site and ensure that all medicines are completely destroyed in accordance with the agreement. 5. Keep records: After destruction, obtain a Certificate of Destruction from the waste-treatment company and archive it together with all other documents, including internal destruction records and supervision records, for at least two years.
Q370 · 作为持牌中药材批发商，我们是否需要遵守“良好分销规范”（GDP）？独立链接
Although the “Good Distribution Practice” (GDP) currently required by Hong Kong legislation primarily concerns the Code of Practice for Pharmaceutical Wholesalers for western medicine wholesalers, its core principles are equally important in protecting the quality of Chinese herbal medicines during storage and distribution, and are regarded by regulators as best practice. Chinese herbal medicines are also exposed to risks from changes in temperature and humidity, insect infestation, mould and cross-contamination. Accordingly, as a responsible Chinese herbal medicine wholesaler, you should voluntarily adopt and implement core GDP principles. These include establishing a quality management system; ensuring staff are appropriately qualified and trained; maintaining compliant storage facilities, such as adequate ventilation and protection against damp and pests; applying effective inventory management, such as first in, first out; keeping complete purchase and sales records for traceability; and establishing procedures for handling complaints and returns.
Q371 · 我们的药品仓库应该如何进行有效的虫害控制？独立链接
Effective pest control is essential for preventing contamination of medicines and maintaining hygienic storage conditions. You need to establish a comprehensive pest management programme. This involves more than simply placing a few mousetraps. The programme should include: 1. Prevention measures, which are the most important part. These include maintaining the building structure in good condition, sealing all potential pest entry routes (such as holes in walls and gaps around doors and windows), keeping the premises and surrounding area clean, and eliminating food sources and standing water. 2. Inspection and monitoring: inspections should be carried out regularly by trained personnel or a professional pest control company, and monitoring devices (such as glue boards and mousetraps) should be placed at key locations (such as entrances and corners), with their locations shown on a plan. 3. Treatment and reporting: if pest activity is detected, appropriate measures that will not contaminate medicines must be taken immediately and documented. Detailed records of all inspection, monitoring and treatment activities must include the date, findings, actions taken and the person responsible.
Q372 · 什么是仓库的“温度图谱研究”（Temperature Mapping Study）？我们必须做吗？独立链接
A temperature mapping study (also known as temperature distribution validation) is a scientific validation exercise. It involves placing sufficient temperature probes at different locations within a warehouse or cold room, including high, low and middle positions and locations near doors, windows and air-conditioning outlets, and continuously recording data over a period of time (usually 7 consecutive days, covering the hottest and coldest seasons). The aim is to identify the hottest and coldest points in the warehouse and demonstrate that temperatures throughout the storage space can be maintained consistently within the specified range, such as 15–25°C or 2–8°C. For all pharmaceutical wholesalers and manufacturers requiring temperature-controlled storage, temperature mapping studies are a mandatory GDP/GMP requirement. They form the basis for demonstrating that your storage facilities can continuously safeguard medicine quality.
Q373 · 当收到客户关于药品质量的投诉时，我们应该如何处理？独立链接
Customer complaints are an important part of the Quality Management System and must be handled seriously and systematically. The standard process is as follows: 1. Record the details: regardless of the channel through which the complaint is received (telephone, email or in person), create a formal complaint record immediately, setting out in detail the complainant’s information, drug name, batch number and specific complaint (such as damaged packaging, unusual colour or foreign matter). 2. Initial assessment: a designated person (usually from the quality department) conducts an initial assessment of the seriousness of the complaint. If a potentially serious safety risk is involved, immediate quarantine of the relevant batch may need to be considered. 3. Investigation: investigate the complaint thoroughly. This may include checking retained samples from the same batch, reviewing production or distribution records, and interviewing relevant personnel to identify the root cause. 4. Take action and respond: take appropriate corrective and preventive action (CAPA) based on the investigation findings. A formal written response must also be provided to the customer within a reasonable time, setting out the investigation findings and the actions the company will take. The entire process must be fully documented.
Q374 · 法规要求记录至少保存两年，我们是否有必要保存更长时间？独立链接
The statutory “at least two years” is a minimum requirement. In practice, however, many companies choose to retain key records for longer as a matter of prudence and risk management. For example, a widely accepted best practice for batch manufacturing and distribution records is to retain them until at least one year after the expiry date of the medicine. This means that if a quality issue or adverse reaction report is identified shortly before or after the medicine expires, you can still trace the complete manufacturing and distribution history for investigation. For some records relating to company operations, validation or critical equipment (such as validation reports, training records for key personnel and change control records), permanent retention is recommended, or at least retention for a substantial period after the relevant system or equipment has been decommissioned.
Q375 · 在日常操作中如果发生了“偏差”（Deviation），我们应该如何处理？独立链接
A “deviation” is any event in which approved instructions or an established Standard Operating Procedure (SOP) is not followed. All deviations, whether planned or accidental, must be formally managed and addressed. The correct procedure is: 1. Report and record immediately: any employee who identifies a deviation is responsible for reporting it promptly to their supervisor and the quality department. A deviation report must be created immediately, detailing when and where the event occurred, the personnel and materials involved, and how the SOP was not followed. 2. Assess the impact: the quality department must promptly assess the potential impact of the deviation on product quality, safety and efficacy. If the impact is serious, the relevant batches may need to be quarantined and release suspended. 3. Investigate the root cause: investigate the cause thoroughly, rather than stopping at “human error”. Examine whether the process was poorly designed, training was inadequate or there was an equipment problem. 4. Establish CAPA: develop and implement effective corrective and preventive action (CAPA) based on the root cause. 5. Close the deviation: after the investigation and corrective actions are complete, the quality department reviews and formally closes the deviation report.
Q376 · 我们应该如何对我们的药品或原材料供应商进行资格认证和管理？独立链接
Supplier management is key to ensuring quality at the start of the supply chain. You should not choose a supplier solely because of its low prices. A sound supplier management procedure should include: 1. Initial assessment and selection: before choosing a new supplier, you must assess its qualifications. This may be done through questionnaires, by requesting evidence of qualifications (such as a manufacturing licence or GMP certificate), or by conducting an on-site audit. Assess its quality management system, manufacturing capacity, compliance history and other relevant factors. 2. Approval and agreements: only suppliers that have passed the assessment may be added to the Approved Supplier List. For suppliers of critical materials, a Quality Agreement should also be signed to define the quality responsibilities of both parties. 3. Ongoing monitoring: continuously monitor supplier performance, for example through indicators such as the acceptance rate of incoming goods, on-time delivery and response times to complaints. 4. Periodic reassessment: reassess suppliers periodically (for example, every 1–3 years, depending on risk level) to ensure that they continue to meet your requirements. Suppliers with serious quality issues or consistently poor performance should be removed from the Approved Supplier List.
Q377 · 对于需要冷链运输的药品，我们如何确保运输过程中的温度合规？独立链接
Ensuring compliant transport temperatures for cold-chain medicines requires a systematic approach to validation and monitoring. First, you need to conduct “transport validation”. This means demonstrating that your chosen transport route, packaging solution (such as insulated boxes and ice packs) and transport equipment can keep the medicines within the specified temperature range, usually 2–8°C, even under worst-case conditions, such as the hottest summer weather and the longest transport time. This is usually done by placing multiple temperature loggers inside the transport containers and conducting actual or simulated transport. Second, a calibrated, independent temperature logger must be used to monitor the goods’ temperature throughout every actual shipment. On receipt, the recipient must check the temperature records immediately and may accept the goods only after confirming that the temperature remained within range throughout. Any temperature excursion must be investigated as a deviation.
Q378 · 什么是“变更控制”（Change Control）系统？为什么它如此重要？独立链接
“Change control” is a formal, systematic process for managing any changes that could affect the quality, safety, efficacy or compliance of medicines. Such changes may include changes to manufacturing processes, replacement of raw material suppliers, updates to analytical methods, upgrades to critical equipment, revisions to Standard Operating Procedures (SOPs), and even alterations to factory facilities. The change control process requires every planned change to be reviewed and approved by a cross-functional assessment team (usually including representatives from production, quality and regulatory affairs) before implementation. The purpose of the assessment is to analyse comprehensively the potential impact and risks of the change and determine the measures required (such as revalidation or notification of the regulatory authority) to ensure that the system remains under control after the change. The application, assessment, approval and implementation of all changes must be fully documented.
Q379 · 卫生署视察员反复强调“数据完整性”（Data Integrity），这具体指的是什么？独立链接
Data integrity has been a major focus of pharmaceutical regulators worldwide in recent years. It refers to the “ALCOA+” principles, which require data throughout its lifecycle to be: attributable (who did it), legible, contemporaneous (recorded at the time the activity occurred), original and accurate. The “+” stands for complete, consistent, enduring and available. Put simply, data integrity requires all your records, whether on paper or electronic, to be genuine, reliable and untampered with. For example, an analyst must not record experimental data on scrap paper and then transcribe it into the official logbook after obtaining a “good” result; an electronic system must not allow ordinary users to amend or delete data at will without any audit trail.
Q380 · 在我们的组织架构中，质量部门（QA/QC）应该扮演什么样的角色？独立链接
In organisations operating in accordance with GDP/GMP, the Quality Unit has an independent and critical role. It consists of Quality Assurance (QA) and Quality Control (QC). QC primarily assesses whether the quality of raw materials, intermediates and finished products meets established standards through sampling and testing. QA has a broader role: it establishes, implements and maintains the company's overall Quality Management System (QMS), ensuring that all activities affecting product quality are controlled. The Quality Unit must be independent of the production or sales departments and have sufficient authority and resources to fulfil its responsibilities. Its core duties include approving or rejecting all quality-related materials and products, approving all SOPs and master documents, managing quality system processes such as deviations, changes and complaints, organising self-inspections, and making the final decision on whether each batch may be released for sale.