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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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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