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.

Q381 · 我们的药房（获授权毒药销售商）在储存和陈列不同类别的“毒药”时，有什么具体规定？独立链接

As a pharmacy, you must comply with strict legal requirements for the storage and display of different categories of poisons, in order to protect public safety and prevent misuse or abuse. Part I poisons (prescription medicines) must never be accessible to the public and must be stored in a “non-public area”, such as a dispensing room or locked cabinet. Part II poisons (medicines sold by medicine shops) may be displayed in public areas, but must be kept separate from other non-medicinal goods, such as food and cosmetics. Certain Part I poisons listed in Schedule 1 are subject to stricter requirements: they must be kept in a locked container, with the key held by a registered pharmacist. All poison storage areas should also be kept clean and dry and protected from direct sunlight to maintain medicine quality.

📘 Regulatory basis

Sections 10 and 11 of the Pharmacy and Poisons Regulations (Cap. 138A) clearly prescribe the storage and custody requirements for Part I and Part II poisons, with the aim of physically segregating medicines with different levels of risk.

📗 Drew Tang's recommendations

We recommend that pharmacies take these requirements fully into account when designing their shop layout. Use clear labels and shelving partitions to distinguish clearly between different categories of products. Train all staff to ensure they know which medicines may be displayed openly and which must be kept under strict control. RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgements are to be verified and assumed by the respective responsible parties, while approval is determined independently by the competent authority. This can also demonstrate your professionalism to customers.

📕 Risk notice

Leaving prescription medicines where customers can easily reach them is an extremely serious breach. If discovered during a Department of Health inspection or if it leads to an incident, the pharmacy may face disciplinary action, including a fine or even revocation of its licence. The pharmacist in charge may also face allegations of professional misconduct.

Q382 · 作为批发商，我们是否可以将大包装的药品拆分后，以小包装单位出售给下游客户？独立链接

As a general rule, a licensed wholesaler should not split or repackage medicines without authorisation, as this constitutes a manufacturing activity and requires a Manufacturer of Pharmaceutical Products licence. You should distribute medicines in the smallest sales unit approved at the time of product registration. Any change to medicine packaging, including opening a bulk pack and repacking it into smaller bottles or boxes, may introduce risks such as cross-contamination, labelling errors and loss of batch number and expiry-date information, thereby compromising the integrity and traceability of the medicines. If you have a genuine business need to carry out such activities, you must apply for a Manufacturer of Pharmaceutical Products licence (secondary packaging) and comply strictly with GMP requirements, carrying out the work in a controlled clean environment and maintaining complete batch packaging records.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138) defines “packaging for sale” as part of “manufacture”. Repackaging medicines without a manufacturer’s licence may therefore constitute unlawful manufacturing.

📗 Drew Tang's recommendations

If your downstream customers (such as clinics and pharmacies) genuinely require smaller pack sizes, we recommend purchasing the required pack size directly from a manufacturer or supplier holding a Manufacturer Licence. This is far safer and more compliant than taking the risk of repackaging products yourself. If you decide to apply for a secondary packaging licence, Rengangyongsheng (Hong Kong) Limited can provide a full suite of services covering GMP facility design, quality system establishment and licence applications.

📕 Risk notice

Unauthorised splitting and repackaging of medicines will be regarded as illegal manufacturing if discovered by the Department of Health. This is a very serious allegation and may result in criminal prosecution and revocation of the existing Wholesale Dealer Licence. In addition, if improper repackaging causes quality problems or harm to patients, you will bear full legal and compensation liability.

Q383 · 对于我们药房保存的旧处方，其中包含病人个人信息，应如何妥善处置？独立链接

A prescription is not only the legal basis for dispensing; it also contains sensitive personal information protected under the Personal Data (Privacy) Ordinance (Cap. 486). It must therefore be handled with great care. First, under the regulations, prescriptions must be kept for at least two years from the date of dispensing. During this period, they must be stored securely to prevent unauthorised access. Once the retention period has expired, they must never be discarded directly as ordinary waste paper. You must destroy them securely to ensure that patient information cannot be recovered. The most common methods are shredding them or engaging a professional confidential document destruction company, and obtaining a certificate of destruction.

📘 Regulatory basis

The Pharmacy and Poisons Regulations (Cap. 138A) require prescriptions to be retained for two years. Data Protection Principle 4 under the Personal Data (Privacy) Ordinance provides that data users must take all practicable steps to ensure that personal data is protected against unauthorised or accidental access, processing or use.

📗 Drew Tang's recommendations

We recommend that pharmacies establish a clear document retention and destruction policy. Prescriptions that have passed their retention period can be destroyed in batches quarterly or annually. Using a high-security cross-cut shredder is a cost-effective in-house method. If prescription volumes are large, outsourcing to a professional destruction company is more efficient and can provide independent evidence of compliance.

📕 Risk notice

Improper disposal of prescriptions containing patient information, if it results in a data breach, will breach both medicines legislation and privacy legislation. The Office of the Privacy Commissioner for Personal Data has the power to investigate and impose penalties. More seriously, this will severely damage your professional reputation and customer trust, causing irreparable harm to the pharmacy’s reputation.

Q384 · 如果我们的仓库温控空调系统在夜间发生故障，导致温度超出范围，我们该怎么办？独立链接

This is an emergency that must be handled immediately and systematically. First, once the fault is detected through the alarm system, send someone to the site immediately to assess the situation and arrange repairs as soon as possible. Second, record the incident immediately as a “deviation”, noting when the fault occurred, when the temperature first went out of range, the highest temperature reading, and the affected areas and medicines. Third, immediately quarantine all affected medicines in the “quarantined goods pending examination” area and label them clearly. They must not be dispatched under any circumstances. Fourth, contact the manufacturer of the medicines concerned or consult their stability data to assess the specific impact of this brief temperature excursion on medicine quality. Some medicines may tolerate short-term temperature fluctuations for a certain period, while others are highly sensitive. Finally, the medicines may be considered for release again only after a written assessment from the manufacturer confirms that their quality has not been affected. Otherwise, they must be destroyed in accordance with the procedure. The entire process must be fully documented.

📘 Regulatory basis

The Code of Practice for Licensed Wholesale Dealers requires storage conditions to be monitored continuously, with any deviations investigated and recorded. This is a core requirement of the quality management system.

📗 Drew Tang's recommendations

Prevention is better than cure. We strongly recommend that clients install backup air-conditioning systems and generators in critical temperature-controlled warehouses. A reliable 24-hour temperature alarm system with remote notifications is an essential investment. Establish communication channels with medicine manufacturers in advance so that technical support can be obtained quickly if such an incident occurs. Prepare a detailed emergency SOP and conduct drills with staff to ensure they know what to do in a real emergency.

📕 Risk notice

Mishandling a temperature excursion or attempting to conceal it is extremely dangerous. Supplying medicines that may have deteriorated to customers directly endangers patient safety. If a Department of Health inspection finds that you have temperature excursion records but did not investigate or deal with them appropriately, this will be considered a critical deficiency, demonstrating a complete failure of your quality system and potentially justifying suspension or revocation of your licence.

Q385 · 什么是“质量风险管理”（QRM）？它在我们的日常运营中如何应用？独立链接

Quality Risk Management (QRM) is a systematic process for assessing, controlling, communicating and reviewing quality risks that may arise throughout a medicine’s lifecycle. It goes beyond simply “following rules”: it proactively and prospectively identifies where things could go wrong and how serious the consequences could be, and allocates resources accordingly, giving priority to high-risk areas. In day-to-day operations, QRM can be applied when conducting risk assessments of different suppliers; assessing risks that may arise from a change during change control; using risk tools to analyse root causes when investigating deviations; and determining the frequency and depth of self-inspections or supplier audits on a risk basis. The key is to make your quality management activities more targeted and direct limited resources where they are most needed.

📘 Regulatory basis

The International Council for Harmonisation (ICH) Q9 guideline, Quality Risk Management, is a globally recognised industry standard. The principles of QRM have been fully incorporated into PIC/S GMP and GDP guidelines, requiring licence holders to establish and operate their quality systems on a risk-based basis.

📗 Drew Tang's recommendations

We recommend that clients start with simple risk management tools, such as FMEA (Failure Mode and Effects Analysis). For example, you could organise a cross-functional team to conduct an FMEA of your goods receipt process, identify all possible “failure modes” (such as receiving the wrong goods or a faulty thermometer), assess their likelihood, severity and detectability, and then develop improvements for high-risk points. Incorporating QRM thinking into day-to-day decisions can make your quality system “smarter” and more efficient.

📕 Risk notice

In the modern pharmaceutical regulatory environment, a Quality Management System (QMS) without risk management is considered outdated and ineffective. If you cannot explain to inspectors why you classify a particular area or process as high risk and have introduced additional controls, or why you consider a deviation low risk and have dealt with it in a simplified way, this may indicate that your decisions are arbitrary and lack a scientific basis. This will reduce the regulatory authorities’ confidence in your overall quality system.

Q386 · 我们应该如何管理和控制我们公司的“标准操作程序”（SOP）文件？独立链接

Standard Operating Procedures (SOPs) are the foundation of a Quality Management System, ensuring operational consistency and compliance. SOP management must be strict and systematic. This includes: 1. Drafting and review: SOPs should be drafted by personnel familiar with the operation, reviewed by the relevant departments (such as the user department and quality department), and ultimately approved by the head of the quality department. 2. Version control: Every SOP must have a unique number, version number and effective date. Any amendment must follow the change control procedure and result in a new version number. Superseded SOPs must be withdrawn immediately from all points of use to prevent misuse. 3. Distribution and training: Controlled copies of SOPs should be distributed to all roles that need to carry out the relevant operations. Relevant employees must be trained before an SOP takes effect, and the training must be documented. 4. Periodic review: All SOPs should be reviewed periodically (for example, every two years) to ensure that their content remains accurate and applicable. If regulations or processes change, they should be revised immediately. 5. Archiving: The master copy of every SOP and all historical versions should be properly archived.

📘 Regulatory basis

Both GMP and GDP guidelines require written procedures to cover all key operations that affect medicine quality, and require these procedures to be properly controlled and managed.

📗 Drew Tang's recommendations

We recommend using an electronic document management system (EDMS) to manage SOPs. This can greatly simplify version control, distribution, retrieval and training record management, while ensuring that employees can always access the latest, sole correct version. SOPs should use clear, concise and unambiguous language, with flowcharts and diagrams used extensively to make them easy to understand and follow.

📕 Risk notice

Poor SOP management is a common inspection deficiency. If staff are found using an obsolete SOP at the workplace, or if actual operations do not match the SOP, this will be regarded as a major deficiency. It indicates that your written procedures are disconnected from actual operations and that your quality system is ineffective. If a quality incident results from following an incorrect SOP, the company will be held responsible.

Q387 · 对于退回、拒收或召回的药品，具体的记录和管理要求是什么？独立链接

Managing returned, rejected and recalled medicines is a key control point for preventing non-conforming goods from re-entering the market. You must establish strict procedures and a record system. First, all such medicines must be immediately segregated in a dedicated, secure, clearly identified physical area and must not be mixed with released goods. Second, every return, rejection or recall must be documented in detail, including the medicine name, batch number, quantity, source (customer), reason and date received. Third, the quality department must assess the medicines and decide on their final disposition. There are only three possible outcomes: a) if it can be confirmed that the medicine’s quality has not been affected (for example, it was simply sent in error and transport conditions were controlled throughout), it may be returned to stock with approval from the head of the quality department; b) if it needs to be destroyed, follow the destruction procedure; or c) if it has been recalled, handle it in accordance with the recall plan. All assessments, decisions and final disposition actions must be documented.

📘 Regulatory basis

The Code of Practice for Licensed Wholesale Dealers has dedicated chapters on handling returned goods and recalls, requiring written procedures and complete records to be maintained.

📗 Drew Tang's recommendations

We recommend that clients design dedicated record forms for these “problem medicines” to ensure that all required information is captured. Provide dedicated training to warehouse staff responsible for handling returns so that they understand the importance of segregation and record-keeping. Conduct regular stocktakes in the quarantine area to ensure that physical stock matches the records. Take particular care when deciding whether high-value returned goods can be returned to stock; if in any doubt, destroy them.

📕 Risk notice

Failure to effectively segregate and control non-conforming goods is a “critical deficiency” in a GDP inspection. If inspectors find recalled goods that should have been segregated stored together with released goods, or you cannot provide the final disposition record for a batch of returned goods, this indicates a serious risk that unsafe medicines could re-enter the market and may lead to immediate regulatory action.

Q388 · 我们应该如何校准我们的关键测量设备，例如仓库的温度探头和实验室的电子天平？独立链接

Equipment calibration is fundamental to ensuring that measurement data is accurate and reliable, and is a prerequisite for data integrity. You must establish a calibration programme for all critical equipment that affects the quality of medicines. The programme should include: 1. Equipment list: list all equipment requiring calibration. 2. Calibration frequency: set a reasonable calibration interval according to the importance and stability of the equipment (for example, calibrate temperature probes annually and electronic balances quarterly). 3. Calibration method: specify the standards and procedures used for calibration. Calibration must be traceable; the standards used for calibration must themselves be traceable to higher-level national or international standards. 4. Implementation and records: calibration may be carried out by competent internal personnel or outsourced to a qualified external organisation (such as a HOKLAS-accredited laboratory). Each calibration must be documented in detail in a calibration certificate, including readings before and after calibration, whether the equipment passed, and the name of the person performing it and the date. All calibrated equipment should be labelled with the date of the latest calibration and the date of the next calibration.

📘 Regulatory basis

Both GMP and GDP guidelines expressly require key equipment used for measurement, weighing, recording and control to be calibrated and checked regularly, with relevant records retained.

📗 Drew Tang's recommendations

We recommend that clients centrally manage calibration plans and records for all critical equipment, using a simple spreadsheet or specialist equipment management software to track due dates and prevent anything being overlooked. If calibration shows that equipment is outside tolerance, a deviation investigation must be initiated to assess the validity of all measurement data affected by the equipment since its last satisfactory calibration, and determine whether product quality was affected.

📕 Risk notice

Data generated using equipment that has not been calibrated or is overdue for calibration is invalid. For example, if the temperature records in your warehouse were generated by a probe that reads 2°C below the true temperature, all your “compliant” temperature records are false, and the medicines may already have been exposed to temperatures outside the permitted range. During an inspection, checking the calibration labels and certificates of critical equipment is a standard requirement; any omission will be recorded as a deficiency.

Q389 · 如果执法机构（如香港海关或警方）要求查阅我们的药品分销记录，我们应该如何应对？独立链接

You must cooperate with lawful requests from law enforcement agencies, while also following procedures to protect the legitimate interests of the company and its customers. The appropriate steps are: 1. Verify identity and authority: Politely ask the officers to show their identification and search warrant or other relevant legal authorisation. You are entitled to verify that they have lawful authority. 2. Contact management and legal counsel: Immediately notify senior management and/or legal counsel so they are aware of the situation and can provide guidance. 3. Clarify the scope and accompany the officers: Establish clearly which records they wish to inspect (for example, for a specific medicine, period or customer). Assign a senior employee to accompany them throughout the inspection, without obstructing their work. 4. Provide copies, not originals: Where possible, provide copies rather than originals. If the officers insist on taking originals, require a detailed receipt listing all documents taken. 5. Record the process: Keep a detailed record of the incident, including the officers’ names and departments, their arrival and departure times, and a list of all documents inspected or taken.

📘 Regulatory basis

Although medicines legislation requires you to keep records, other laws, such as the Criminal Procedure Ordinance, empower law enforcement agencies to inspect and seize evidence in certain circumstances. At the same time, you are responsible for protecting customer information under the Personal Data (Privacy) Ordinance, unless disclosure is required by law.

📗 Drew Tang's recommendations

We recommend that the company prepare an SOP in advance for responding to enforcement inspections and train key staff. Keeping all distribution records complete, accurate and readily retrievable will enable the required information to be provided quickly and accurately in such circumstances, avoiding unnecessary suspicion caused by disorganisation. If you are unsure how to proceed, it is prudent to delay and seek advice from legal counsel.

📕 Risk notice

Obstructing enforcement officers in the execution of their duties is a criminal offence. However, handing over large volumes of records containing commercially sensitive information and customer privacy data to others without verifying their authority is also irresponsible. It is essential to strike a balance between cooperation and caution. An inappropriate response may expose the company to legal risks or reputational damage.

Q390 · 什么是“合格人士”（QP）与“负责人”（RP）？他们在药品监管中的角色有何不同？独立链接

A “Qualified Person” (QP) and a “Responsible Person” (RP) are two distinct but equally important roles in the regulatory framework for medicines. QP is a legal concept under the EU and PIC/S GMP systems and is primarily found in pharmaceutical manufacturing. The QP’s core responsibility is to personally review batch records and issue a declaration before each batch of medicine is placed on the market, confirming that the manufacturing and testing of the batch fully comply with GMP requirements and the marketing authorisation. The QP bears personal legal responsibility for product quality. By contrast, the RP is a GDP concept found primarily in pharmaceutical wholesale and distribution. The RP is responsible for ensuring that the wholesaler’s Quality Management System is effectively implemented and maintained, and that medicines retain their quality and integrity during storage and distribution. The RP is responsible for compliance in wholesale activities. In short, the QP is responsible for “release from manufacture” and ensuring manufacturing quality; the RP is responsible for “distribution compliance” and ensuring supply chain quality.

📘 Regulatory basis

Chapter 2 of the PIC/S GMP Guide defines the responsibilities and qualification requirements of a QP in detail. Hong Kong's Drug Wholesalers Code of Practice sets out the appointment and responsibilities of an RP.

📗 Drew Tang's recommendations

Companies holding both a Manufacturer of Pharmaceutical Products licence and a wholesale licence must clearly distinguish the responsibilities of the two roles and define them in their quality system documentation. Although the same person may hold both roles in a small company, they must have all the knowledge and experience required for each role and be able to “switch hats” clearly when performing different duties. The QP’s decisions should focus on the batch itself, while the RP’s decisions should cover the entire distribution chain.

📕 Risk notice

Confusion over the responsibilities of the QP and RP may create regulatory gaps. For example, a QP focused only on production may overlook risks in distribution, while an RP familiar only with storage may be unable to make an informed quality assessment of production deviations. The performance of these two key roles is assessed in depth during Department of Health inspections; unclear responsibilities or insufficient capability will be treated as a major systemic deficiency.

Q391 · 我们的年度自检（Self-Inspection）应该由谁来执行才能保证其客观性？独立链接

The purpose of annual self-inspection is to conduct a critical and honest assessment of your own Quality Management System, so objectivity and independence are essential. To ensure this, the people or team conducting the self-inspection should be as independent as possible from the activities being inspected. Best practice is to: 1. Form a self-inspection team with members from different departments—for example, have production staff inspect the warehouse and warehouse staff inspect the quality control laboratory, creating cross-checks. 2. Appoint a member of management who is not directly responsible for specific operations, such as the quality assurance manager, to lead the team. 3. If the company’s size and resources permit, engage an independent external consultant or auditor to conduct the self-inspection. This can provide the most objective perspective and may bring experience of industry best practices. Regardless of who conducts it, self-inspection personnel must receive appropriate training and be familiar with GDP/GMP requirements and auditing techniques.

📘 Regulatory basis

Both the Code of Practice for Licensed Wholesale Dealers and GMP guidance require self-inspections to be conducted by designated, competent personnel who are independent of the department being inspected, to ensure that the inspection is impartial and thorough.

📗 Drew Tang's recommendations

We do not recommend that department heads inspect their own departments, as genuine objectivity is difficult to achieve. Treat self-inspection as an opportunity for internal learning and improvement, not fault-finding. Be open to issues identified by external auditors. Rengangyongsheng (Hong Kong) Limited provides professional third-party self-inspection services to help you review your systems from a fresh perspective and prepare for an official inspection.

📕 Risk notice

A superficial “friendly” self-inspection carried out by non-independent personnel will almost certainly miss many potential problems. This can give management the false impression that “everything is fine” and cause them to lower their guard. When Department of Health inspectors arrive and find numerous problems, you will have to address not only the problems themselves but also explain why your self-inspection system failed to identify them, making the situation worse.

Q392 · 我们是一家中成药零售商，在销售附表一的中药材（如附子、川乌）时，有哪些特殊的日常监管要求？独立链接

As a licensed proprietary Chinese medicine retailer, you must meet stricter regulatory requirements than those applying to ordinary Chinese herbal medicines when selling toxic Chinese herbal medicines listed in Schedule 1, in order to protect public safety. In day-to-day operations, you must: 1. Obtain a prescription from a registered Chinese medicine practitioner before dispensing and selling; sales without a prescription are strictly prohibited. 2. Keep a dedicated “toxic Chinese herbal medicine sales register” recording each transaction in detail, including the date, patient's name and address, prescribing Chinese medicine practitioner's name, name of the medicine and quantity sold. 3. Store these medicines in a dedicated locked cabinet, clearly separated from other medicines to prevent confusion or misuse. 4. Ensure that dispensing is carried out by a registered Chinese medicine practitioner or a Chinese medicine dispensing assistant under the supervision of a registered Chinese medicine practitioner. 5. Clearly mark the medicine container with the words “poison” or “Toxin” and other warning information.

📘 Regulatory basis

The Chinese Medicine Ordinance (Cap. 549) and its subsidiary legislation, the Chinese Medicines Regulation, set out strict requirements for the retail, labelling, storage and record-keeping of Chinese herbal medicines listed in Schedule 1.

📗 Drew Tang's recommendations

We recommend that retailers provide dedicated training to all staff to ensure that they can accurately identify Schedule 1 Chinese herbal medicines and understand the relevant sales restrictions. The register should be checked daily to ensure that no entries are missing. When receiving prescriptions from Chinese medicine practitioners, check them carefully and proactively contact the prescribing practitioner for confirmation if anything is in doubt (for example, an unusually high dose). This is both a compliance requirement and a professional responsibility to protect patients and yourself.

📕 Risk notice

Illegal sale of Schedule 1 toxic Chinese herbal medicines is a serious criminal offence. Investigators from the Chinese Medicine Council of Hong Kong may conduct undercover operations. If a breach is established, the shop and persons responsible may face prosecution and substantial fines, and the professional qualifications of the Chinese medicine practitioner or dispenser concerned may also be suspended or revoked. This is an absolute red line.

Q393 · 卫生署要求我们提交“场地主文件”（Site Master File, SMF），这是什么文件？我们应该如何准备？独立链接

A Site Master File (SMF) is a detailed document prepared by a medicine manufacturer or wholesaler describing the company’s activities relating to the handling of medicines (such as production, packaging, quality control and distribution). It does not replace documents such as master batch records; rather, it provides an overview of the company’s overall quality management policy and activities, enabling the regulatory authority to gain a clear and comprehensive understanding of the company before an on-site inspection. The SMF follows a set format and usually includes basic company information, the Quality Management System, personnel and organisational structure, premises and equipment, the document management system, production operations, quality control, distribution/complaint/recall activities and self-inspection. Preparing an SMF requires the systematic review and summary of all relevant company SOPs and policies, presented clearly, concisely and accurately.

📘 Regulatory basis

The PIC/S GMP Guide and EU EudraLex Volume 4 provide detailed guidance on the format and contents of an SMF. The Department of Health in Hong Kong will usually ask licence holders to provide this document when applying for a manufacturer's licence or during a GMP/GDP inspection.

📗 Drew Tang's recommendations

We recommend treating the SMF as the company’s “quality CV”. It should be kept up to date, with any significant changes (such as a change of quality lead or the addition of a new production line) reflected promptly. It should be prepared honestly and accurately, without exaggeration or concealment. A well-written, logically structured SMF can make a professional and rigorous first impression on inspectors. If you lack experience in preparing one, you can seek help from a professional consultant such as Rengangyongsheng (Hong Kong) Limited.

📕 Risk notice

Submitting an SMF that is inaccurate, outdated or seriously inconsistent with actual operations will severely damage your credibility. Inspectors will use the SMF as a blueprint for their on-site checks. Any major discrepancies may be regarded as evidence of data integrity issues or poor management, leading to a more in-depth and rigorous review.

Q394 · 我们的牌照即将到期，续牌的流程是怎样的？需要提前多久开始准备？独立链接

Medicine-related licences, such as wholesaler and manufacturer licences, are not valid indefinitely and must be renewed periodically. The renewal process is generally as follows: about 3–4 months before the licence expires, the Department of Health will send a renewal application form. You need to complete it, confirm that there have been no unapproved changes to the company’s registration details, key personnel or premises address, and return it to the Department of Health with the specified renewal fee. After receiving the application, the Department of Health may decide whether to conduct an on-site inspection before renewal, based on a risk assessment. If the company has a good compliance record and there have been no significant changes, renewal will generally proceed smoothly. Once approved, the Department of Health will issue a new licence. You should start preparing for renewal at least 3 months before expiry, allowing sufficient time to address any issues that may arise.

📘 Regulatory basis

The validity periods and renewal requirements for the various pharmaceutical licences are set out in their respective legislation (such as the Pharmacy and Poisons Ordinance and the Chinese Medicine Ordinance) and licence conditions.

📗 Drew Tang's recommendations

Do not leave renewal matters until the last minute. We recommend that clients conduct an internal review as soon as they receive the renewal notice, to ensure that all registered particulars are up to date and that all changes made during the previous licence cycle (such as a change of Person-in-Charge) have been notified to the Drug Office as required and approved. Discovering an unnotified change only when submitting the renewal application may complicate the process.

📕 Risk notice

Failure to renew your licence on time will cause it to expire. Once it has expired, you must immediately stop all relevant licensed activities, such as wholesale, manufacture or retail of medicines. Otherwise, you will be operating without a licence, which is a serious criminal offence. Reapplying for a licence is a lengthy and complicated process, far more difficult than renewing on time. Licence renewal must therefore be treated as a top priority for the company’s operations.

Q395 · 在日常工作中，我们如何确保员工遵守个人卫生（Personal Hygiene）要求？独立链接

Good personal hygiene is the first line of defence against contamination of medicines, particularly microbial contamination, and is emphasised in both GMP and GDP. To ensure staff comply, you should: 1. Establish clear SOPs: Create an SOP on personal hygiene specifying that staff must wash their hands and wear designated clean work clothing, footwear, hairnets and masks before entering areas where medicines are handled. The SOP should also prohibit eating, drinking, smoking and chewing gum in work areas, and prohibit wearing jewellery that could come loose. 2. Provide facilities and supplies: The company must provide adequate handwashing facilities, disinfectant and clean, well-fitting work clothing. 3. Provide training: All staff, including temporary workers and visitors, must receive training on personal hygiene requirements before entering work areas. Training should be repeated regularly to reinforce awareness. 4. Supervision and enforcement: Supervisors and quality personnel should monitor compliance with personal hygiene requirements during day-to-day work and correct any breaches. 5. Health management: Require staff to report to their supervisor if they are ill or have open skin wounds, and temporarily reassign them from roles involving direct contact with medicines.

📘 Regulatory basis

Chapter 2, “Personnel”, of the PIC/S GMP Guide and the Drug Wholesalers Code of Practice both set out clear and detailed personal hygiene requirements, treating them as part of personnel qualifications.

📗 Drew Tang's recommendations

We recommend making personal hygiene requirements the first topic in new employee induction training. Illustrated reminder posters displayed in changing rooms and at entrances to work areas can be effective prompts. Management should lead by example and observe the same hygiene standards; this is essential to building a good hygiene culture.

📕 Risk notice

Poor personal hygiene is a major source of microbial contamination. In high-risk areas such as aseptic production, staff negligence may contaminate an entire batch, causing substantial losses and safety risks. If inspectors observe that staff generally fail to comply with personal hygiene requirements during a Department of Health inspection, this will be regarded as direct evidence of management shortcomings and inadequate training, and is a serious deficiency.

Q396 · 我们是一家小型批发商，是否也需要建立一套完整的质量管理体系（QMS）？独立链接

Absolutely. Regardless of the size of your company, if you are a licensed pharmaceutical wholesaler, you must establish and operate a Quality Management System (QMS) that meets GDP requirements. GDP regulations and codes of practice apply to all licensees; there is no “small business exemption”. The complexity of the QMS may, of course, be proportionate to the size and complexity of the company’s business. A small wholesaler’s QMS need not be as extensive as that of a large multinational company, but it must include all the core elements: a documented quality policy and objectives; a clear organisational structure and defined responsibilities; written SOPs for all key activities (such as procurement, receipt, storage, sales, complaints and recalls); and systems for managing personnel, premises, documents, deviations and changes.

📘 Regulatory basis

The first chapter of the Code of Practice for Licensed Wholesale Dealers states at the outset that licensees must “establish and maintain a satisfactory quality system”, making this the foundation of the entire code.

📗 Drew Tang's recommendations

We recommend that small businesses view the QMS not as a burden, but as a tool for standardising operations, reducing risks, improving efficiency and enhancing their professional image. You can start with standard QMS templates and adapt them to your specific business. The key is to “say what you do, write what you say, and do what you write”. Ensure that your SOPs are tailored to your business rather than copied from elsewhere and disconnected from actual operations. Rengangyongsheng (Hong Kong) Limited can help you establish a streamlined and effective QMS cost-effectively.

📕 Risk notice

Claiming that a QMS has not been established or effectively operated because the “company is small and the business is simple” is wholly unacceptable during a Department of Health inspection. This will be regarded as fundamental non-compliance and evidence that you do not meet the basic qualifications to operate as a licensed wholesaler. The consequence may be more than a deficiency report; you could face suspension or revocation of your licence.

Q397 · 在进行药品进出口时，除了卫生署的许可证，我们还需要注意香港海关的哪些规定？独立链接

When importing or exporting medicines, in addition to obtaining import/export licences issued by the Department of Health in advance, you must comply with Hong Kong Customs clearance requirements. For every consignment entering or leaving Hong Kong, an accurate and complete import/export declaration must be submitted to Hong Kong Customs within 14 days after the goods arrive in or depart from Hong Kong. For medicines, you must declare the correct Harmonized System (HS) code and state the Department of Health licence number. Hong Kong Customs is entitled to inspect goods entering or leaving Hong Kong to ensure that the declaration matches the goods and to verify the relevant licences. If your medicines contain ingredients controlled under the Dangerous Drugs Ordinance, you must also comply with more stringent licensing and secure transport requirements.

📘 Regulatory basis

The Import and Export Ordinance (Cap. 60) sets out the declaration requirements for all imports and exports. The Hong Kong Customs and Excise Department enforces this Ordinance and the provisions on cargo control in other relevant laws, including the Dangerous Drugs Ordinance (Cap. 134).

📗 Drew Tang's recommendations

We recommend that clients engage an experienced customs broker to handle import and export customs declarations to ensure accuracy and timeliness. Before goods are shipped, provide the broker with the full set of documents (including the invoice, packing list, bill of lading and Department of Health licences). Keeping all customs declaration documents and records of correspondence with Customs is part of day-to-day compliance management.

📕 Risk notice

Failure to submit customs declarations on time or accurately may result in fines from Customs. More seriously, if the declared medicine information does not match the actual goods, or you cannot provide a valid Department of Health licence, the goods will be detained and may be treated as smuggling, leading to a criminal investigation. This will not only cause substantial financial losses but also put the company’s licence and reputation at serious risk.

Q398 · 什么是“数据完整性审计追踪审核”（Data Integrity Audit Trail Review）？我们需要做吗？独立链接

“Audit trail review” is a key activity for ensuring the integrity of electronic record data. Modern compliant electronic systems, such as LIMS, ERP and chromatography data systems, have an “audit trail” function that automatically records all activities involving the creation, modification or deletion of data, including the operator, time, original value and new value. However, having this function is not enough: you must regularly review the audit trail records. The purpose is to proactively identify any unusual or suspicious activity. For example, has someone been making frequent changes to data late at night? Has anyone attempted to delete a failed test result? Has anyone changed the system time without a valid reason? Regular, targeted reviews can deter and detect potential data falsification. Regular audit trail reviews are essential for critical electronic systems.

📘 Regulatory basis

Data integrity guidance issued by various regulators, such as the MHRA and PIC/S, clearly states that systems with audit trail functionality must have procedures requiring regular review of the audit trail.

📗 Drew Tang's recommendations

We recommend that clients use risk assessments to determine the frequency and depth of audit trail reviews for different systems. For example, audit trails for a QC laboratory chromatography system that generates final release data may need to be reviewed batch by batch or weekly. Reviews can be less frequent for lower-risk systems. Reviews should be conducted by personnel independent of data generation (such as QA), and the review process and findings should be recorded.

📕 Risk notice

During an inspection, if the inspector asks how you review audit trails and you cannot answer or say that you have never done so, this will be regarded as a major data integrity deficiency. It shows that although you have installed a ‘camera’ (the audit trail function), you have never reviewed the footage and have no monitoring in place for potential misconduct. This may cause the inspector to fundamentally question the reliability of all your electronic records.

Q399 · 如果我们的药品需要进行临床试验，这在香港受到哪些额外的监管？独立链接

Clinical trials conducted in Hong Kong for the purpose of obtaining pharmaceutical product registration must comply with requirements that are stricter than those for routine medicine management. First, the sponsor (usually a pharmaceutical company) must apply to the Department of Health for a “Certificate for Clinical Trial/Medicinal Test”. The application must include a detailed trial protocol, Investigator’s Brochure, sample informed consent form and approval documents from the ethics committee (IRB/IEC). Second, the labelling, manufacture, packaging and distribution of all investigational medicinal products (IMPs) must meet the specific requirements of GMP and relevant guidelines, ensuring that their quality and blinding are not compromised. Third, all serious adverse events (SAEs) occurring during the trial must be reported to the Department of Health within the prescribed time limits. The entire trial must strictly follow the principles of Good Clinical Practice (GCP).

📘 Regulatory basis

Section 36B of the Pharmacy and Poisons Regulations (Cap. 138A) sets out the requirements for applying for a clinical trial certificate. The International Council for Harmonisation (ICH) E6 guideline, Good Clinical Practice (GCP), is the globally recognised gold standard for clinical trials, and the Hong Kong Department of Health has fully adopted it.

📗 Drew Tang's recommendations

Our recommendation to sponsors planning to conduct clinical trials in Hong Kong: 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. Ensuring that your trial protocol is scientifically sound and ethically compliant, and that all documents are fully prepared, is key to obtaining approval. The management of investigational medicinal products requires a separate, highly rigorous supply chain and record-keeping system. RGYS can connect you with leading CRO resources and provide regulatory support throughout the process.

📕 Risk notice

Conducting a clinical trial without prior approval, or seriously breaching GCP principles during a trial, may invalidate the trial data so that it cannot be used for product registration. It may also expose you to legal proceedings and criminal prosecution for endangering participant safety. This is a serious violation of scientific, ethical and legal principles, with extremely serious consequences.

Q400 · 作为持牌人，我们对公司的“合规文化”（Compliance Culture）建设负有什么责任？独立链接

As a licence holder, the company's senior management has ultimate and non-delegable responsibility for establishing and maintaining a positive, organisation-wide “compliance culture”. This involves far more than appointing a compliance officer or writing a few SOPs. Your responsibilities include: 1. **Lead by example**: Demonstrate through all your words and actions the highest commitment to quality and compliance, and never compromise for short-term gain. 2. **Provide resources**: Ensure that the quality and compliance departments have sufficient and independent funding, staff and authority to fulfil their duties. 3. **Set expectations**: Use the company's quality policy and ongoing internal communications to make clear to every employee that compliance is everyone's responsibility, not just the quality department's. 4. **Encourage reporting and continuous improvement**: Create a “blame-free” environment that encourages staff to report errors, deviations and potential issues, treating them as opportunities to improve the system rather than reasons for punishment. 5. **Review performance**: Systematically review the performance of the quality system at regular management review meetings and set directions and targets for continuous improvement.

📘 Regulatory basis

Chapter 1, “Pharmaceutical Quality System”, of the PIC/S GMP Guide expressly emphasises that “management commitment” is a prerequisite for the success of the entire system. Regulators are increasingly focusing on this intangible “cultural” factor.

📗 Drew Tang's recommendations

We recommend that you treat building a compliance culture as a long-term, core strategic investment. Regularly discuss quality at company meetings, publicly recognise employees who contribute to compliance, and personally participate in key quality decisions. The message conveyed by these actions is far more powerful than any written document. A strong compliance culture is the company’s most robust competitive advantage.

📕 Risk notice

If the company culture condones or even encourages “shortcuts”, it is only a matter of time before a breach occurs, no matter how perfectly your SOPs are written. During an in-depth inspection, inspectors can quickly gauge the company's real culture through interviews with staff at all levels. If they believe that senior management pays lip service to compliance, they will lose confidence in all the company's records and commitments, which could lead to the most severe regulatory findings.

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