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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Q351 · 作为持牌批发商，我们每天需要履行的核心合规义务有哪些？独立链接
As a licensed wholesale dealer, day-to-day compliance is the foundation for maintaining the validity of your licence. You must ensure that all procurement, storage, sale and distribution activities involving medicines strictly comply with Hong Kong law. Core obligations include: first, establishing and maintaining a robust Quality Management System (QMS) covering all operating procedures. Second, ensuring that all medicines are procured from qualified suppliers and keeping complete purchasing records. Third, storing medicines strictly in accordance with the label instructions, particularly those requiring specific temperature or humidity conditions, which must be monitored continuously and recorded. Fourth, keeping detailed sales and distribution records to ensure traceability; records must be retained for at least two years. Fifth, appointing one or more responsible persons to oversee day-to-day operations and ensuring all staff receive appropriate training and are familiar with their duties and relevant regulatory requirements.
Q352 · 卫生署药物办公室进行例行视察时，通常会重点检查哪些方面？我们应该如何准备？独立链接
Routine inspections by the Department of Health are intended to ensure that licence holders continue to comply with the relevant legislation and codes of practice. Inspections are usually unannounced, although advance notice may also be given. The main areas checked include: 1. Premises and facilities: whether they meet the standards set at the time of licensing, particularly whether the warehouse environment for medicine storage meets the requirements. 2. Documents and records: the main focus of the inspection, including records of medicine purchases, sales and stock, as well as temperature monitoring and staff training records. 3. Operation of the Quality Management System: inspectors will sample-check whether your Standard Operating Procedures (SOPs) are being implemented effectively. 4. Personnel qualifications and responsibilities: ensuring that personnel in key roles have the relevant qualifications and clearly understand their responsibilities. To prepare, ensure all documents and records are well organised and readily accessible, and provide staff with regular training and mock inspection exercises so they can remain composed and answer questions accurately during an inspection.
Q353 · 关于药品的进出记录，卫生署要求的具体标准是什么？需要保存多久？独立链接
Records of medicine receipts and issues are central to the medicine traceability system and a key focus of regulatory inspections. Under the requirements, records of all receipts and issues of Part I poisons and dangerous drugs in Schedules 1 and 3 must be detailed and accurate. The specific standards are as follows: for purchases (receipts), records must include the purchase date, medicine name, dosage form, strength, quantity, and supplier’s name and address. For sales (issues), records must include the sale date, medicine name, dosage form, strength, quantity, and purchaser’s name and address. Each transaction should be supported by a corresponding invoice or document. All records must be maintained legibly and indelibly, whether in paper ledgers or an electronic system. They must be entered as soon as possible after each transaction and retained for at least two years from the date of the last entry.
Q354 · 如果发现或收到关于药品不良反应的报告，我们应遵循怎样的呈报程序？独立链接
Monitoring and reporting adverse drug reactions (ADRs) is an important duty of licence holders in safeguarding public medicine safety. If, as a licensed wholesaler or manufacturer, you learn through any channel (such as healthcare professionals, patients or sales representatives) of information about a serious adverse reaction to a medicine you supply, you must initiate the reporting procedure. This generally involves: first, conducting an initial assessment immediately and collecting as much detail as possible, including information about the patient, medication history, and the nature and course of the adverse reaction. Next, completing the ADR report form provided by the Drug Office, Department of Health, under the Drug Safety Monitoring Programme. Finally, reporting it to the Department of Health within the prescribed time limit according to the seriousness of the reaction (unexpected and serious ADRs are generally required to be reported within 15 calendar days).
Q355 · 在什么情况下需要启动药品召回？具体的流程是怎样的？独立链接
A medicine recall is an urgent measure taken to protect public health when a quality, safety or efficacy problem is found in a medicine already on the market. Circumstances requiring a recall include contamination, incorrect labelling, packaging defects, incorrect active ingredient content and failed stability tests. Once a recall is deemed necessary, the licensed manufacturer or wholesaler must immediately notify the Department of Health and initiate its internal recall procedure. The general process is: 1. Risk assessment: determine the seriousness of the issue and its potential scope, and define the recall level (for example, recall to the doctor/pharmacy level or to the consumer level). 2. Notification and communication: submit a detailed recall plan to the Department of Health and promptly notify all affected downstream customers, such as other wholesalers, hospitals and pharmacies. 3. Recall execution: arrange logistics to retrieve all affected batches and segregate them in storage. 4. Investigation and reporting: thoroughly investigate the root cause, take corrective and preventive action (CAPA), and submit the final recall and investigation reports to the Department of Health.
Q356 · 什么是年度自我视察（Self-Inspection）？它和卫生署的视察有何不同？独立链接
Annual self-inspection is an important part of a licence holder’s Quality Management System (QMS) and is a proactive internal compliance audit. Its purpose is to systematically and critically review all company activities related to medicine quality, assess ongoing compliance with Good Distribution Practice (GDP) or Good Manufacturing Practice (GMP) requirements, and identify areas for improvement. It differs from a Department of Health inspection in three main respects: first, in nature—the former is an internal, proactive activity, while the latter is an external regulatory activity; second, in purpose—self-inspection aims at self-improvement and continual improvement, while a Department of Health inspection aims at enforcement and oversight; and third, in frequency and scope, which can be more flexible, allowing the company to conduct more frequent internal audits of high-risk areas based on risk assessment.
Q357 · 对于处理药品的员工，我们需要提供哪些必要的培训？培训记录需要多详细？独立链接
Staff are the first line of defence in ensuring medicine quality and compliant operations, so ongoing, effective training is essential. Necessary training should include: 1. Induction training covering the company's quality policy, basic GDP/GMP concepts, personal hygiene requirements, and employees' own roles and relevant Standard Operating Procedures (SOPs). 2. Role-specific skills training for particular tasks such as receipt, acceptance, storage, picking, packing and transport. 3. Medicine knowledge training, particularly on the characteristics, storage conditions and expiry-date management of the medicines handled. 4. Compliance and regulatory training to refresh staff regularly on relevant legislation, including the Pharmacy and Poisons Ordinance. Training records must be comprehensive and include the date, subject, outline of content, trainer, employee signatures and an assessment of training effectiveness. These records are key evidence to the regulator that you have fulfilled your training obligations.
Q358 · 我们是一家持牌批发商，如果需要从海外进口或出口药品，需要申请额外的许可吗？独立链接
Yes, holding a Wholesale Dealer Licence does not automatically grant the right to import or export medicines. The import and export of medicines are strictly controlled under Hong Kong law. You must apply to the Department of Health for an import or export licence for each consignment of pharmaceutical products or substances registered in Hong Kong, whether importing or exporting. You will need to provide detailed information about the goods, including the medicine name, ingredients, quantity and manufacturer details, as well as relevant supporting documents from the place of origin or destination country. The Department of Health will assess each application to ensure that the import or export activities comply with local regulations and international standards. Unregistered medicines are in principle not permitted to be imported or exported unless a special exemption is granted (for example, for clinical trials or a specific patient).
Q359 · 在药品库存管理方面，除了保证先进先出，还有哪些关键的合规要点？独立链接
Effective inventory management is central to ensuring medicine quality and safety. In addition to strictly applying the “first-expired-first-out” (FEFO) principle (that is, dispatching items with the earliest expiry date first, which is more accurate than FIFO), the following key compliance points apply: 1. Clear zoning: the warehouse must have clearly designated areas for quarantined goods pending examination, released goods, non-conforming goods, returned goods and recalled goods, with clear signs to distinguish them and prevent mix-ups and cross-contamination. 2. Environmental monitoring: medicines with specific temperature and humidity requirements must be monitored and recorded continuously, 24 hours a day, using calibrated equipment. There must be an emergency plan for environmental excursions, and actions taken must be documented. 3. Regular stocktakes: stock must be counted regularly, and physical inventory reconciled against stock records. Any discrepancies must be investigated and documented. 4. Expiry-date management: establish an expiry-date alert system and closely monitor medicines approaching their expiry date to prevent expired medicines from being dispatched accidentally. 5. Security: take appropriate security measures to prevent unauthorised access to storage areas and prevent medicines from being stolen or tampered with.
Q360 · 作为“获授权毒药销售商”（药房），我们销售第一部毒药时，对处方有什么具体要求？独立链接
As an authorised pharmacy, you must dispense Part I poisons strictly in accordance with a prescription issued by a qualified registered medical practitioner, dentist or veterinary surgeon. The prescription must be lawful and complete. Specific requirements include: 1. It must be written in indelible form. 2. It must include the date of issue, the patient's full name and address, and the prescribing practitioner's name, address and signature. 3. It must clearly state the name of the medicine to be dispensed, dosage instructions and total quantity to be supplied. 4. For certain strictly controlled dangerous drugs, the patient's identity card number may also be required on the prescription. Before dispensing, the pharmacist is responsible for verifying the prescription's authenticity and reasonableness. If there is any doubt, such as an unusual dosage or suspected forgery, the pharmacist must contact the prescriber for confirmation before dispensing.
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.