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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Q101 · 申请香港药品批发商牌照，对申请公司本身有什么基本资格要求？独立链接

A company applying for a pharmaceutical product wholesale dealer licence in Hong Kong must be a limited company duly incorporated under Hong Kong's Companies Ordinance (Cap. 622). This is the basic requirement for the applicant entity. In addition, the company must have a fixed, lawful business address in Hong Kong to serve as its registered office and actual place of business. The premises must meet the standards for medicine storage, management and distribution under the Pharmacy and Poisons Ordinance and its subsidiary regulations. Before issuing a licence, inspectors from the Drug Office, Department of Health will conduct an on-site inspection to ensure that the facilities, security system, temperature controls and Quality Management System meet statutory requirements. The company must also demonstrate a sound financial position sufficient to support the normal operation of its licensed pharmaceutical business.

📘 Regulatory basis

Under the Pharmacy and Poisons Ordinance (Cap. 138) and the Code of Practice for Drug Dealers issued by the Drug Office, applicants must be corporate bodies with actual business operations in Hong Kong. Their premises must meet the requirements of Good Distribution Practice (GDP) for medicines.

📗 Drew Tang's recommendations

We recommend that clients complete company registration and rent or purchase suitable business premises before submitting an application. We will help clients review the tenancy agreement to ensure that it meets the Drug Office requirements. Establishing a complete QMS document set in advance is also a key advantage during the on-site inspection.

📕 Risk notice

Do not use a virtual office or company secretary’s address as your business premises for an application; it is almost certain to be rejected. If the premises’ physical facilities (such as air conditioning, refrigerators and security systems) fail to meet the requirements during inspection, the application process may be seriously delayed or you may even need to reapply.

Q102 · 非香港居民是否可以作为公司的董事或股东申请药品相关牌照？独立链接

Yes. Hong Kong’s legal system is open to business investment and does not restrict the nationality of directors or shareholders of a licensed medicines company. Mainland Chinese residents and foreign nationals alike may be directors or shareholders of an applicant company. However, the company must be able to demonstrate substantive management and control in Hong Kong, regardless of the directors’ nationality. In addition, all directors and senior management must meet the ‘Fit and Proper Person’ requirements. This means that they must be of good character, reputation and integrity, have no relevant criminal convictions, and have no history of breaching medicines regulations. The Drug Office will conduct background checks on all key personnel.

📘 Regulatory basis

The Hong Kong Companies Ordinance (Cap. 622) imposes no specific nationality restrictions on directors. However, when considering an application, the Pharmacy and Poisons Board (PPB) will assess the applicant’s fit and proper status in full; this is one of its important discretionary powers.

📗 Drew Tang's recommendations

We recommend that, if the company’s senior management team members are not Hong Kong residents, it appoint at least one director or senior manager resident in Hong Kong to handle day-to-day communications with regulators and ensure local compliance. This helps demonstrate to the Drug Office the company’s commitment to its Hong Kong business and the substance of its local management.

📕 Risk notice

If a company's directors or shareholders have a record of pharmaceutical-related offences in another country, or are under investigation, this must be disclosed proactively at the time of application. If such information is concealed and later discovered, not only may the application be rejected, but the company and the relevant individuals may also be blacklisted, affecting any future licence applications.

Q103 · 什么是“获授权人”（Authorized Person, AP）制度？在药品批发商牌照申请中，AP的职责是什么？独立链接

The “Authorised Person” (AP) system is a key element in ensuring the safety and quality of the medicine supply chain. For a pharmaceutical wholesaler, the AP is a staff member formally authorised in writing by the licensee to oversee and manage all activities relating to the procurement, storage, sale and distribution of medicines. The AP must ensure that all operations comply with the Pharmacy and Poisons Ordinance and Good Distribution Practice (GDP). Core responsibilities include approving and managing suppliers and customers, ensuring that medicines are from lawful sources, overseeing medicine storage conditions, handling customer complaints and medicine recalls, and maintaining complete distribution records. The AP is one of the company’s main contacts for communication with the Drug Office and bears significant responsibility for licence compliance.

📘 Regulatory basis

The Code of Practice for Holder of Wholesale Dealer Licence sets out in detail the role, responsibilities and qualification requirements of the Authorised Person. The AP’s appointment and qualifications are key areas reviewed by the Drug Office.

📗 Drew Tang's recommendations

An AP does not necessarily have to be a pharmacist, but must have relevant industry experience and knowledge of medicines. We generally recommend appointing a senior employee with at least 3–5 years' experience in pharmaceutical distribution or quality management. Clearly setting out the AP's qualifications and division of responsibilities in the application documents is crucial.

📕 Risk notice

If an AP fails to perform their duties effectively—for example, by failing to prevent counterfeit or unregistered medicines from entering the supply chain—the company may face serious legal consequences, including fines and licence revocation, and the relevant persons in charge may even face criminal prosecution. An AP's failure to discharge their duties is one of the greatest compliance risks for a licence holder.

Q104 · 申请批发商牌照的“负责人员”（Responsible Person, RP）需要具备什么样的学历和经验？独立链接

The “Responsible Person” (RP) is central to a Wholesale Dealer Licence application, and their qualifications directly affect the outcome of the application. According to the Drug Office’s guidance, the RP must have sufficient knowledge and experience to oversee the handling of medicines. Specifically, an RP will generally need to meet one of the following criteria: 1) be a registered pharmacist in Hong Kong; 2) hold a university degree in pharmacy, medicine or a related scientific discipline, and have at least one year of relevant work experience in the pharmaceutical industry; 3) hold a higher diploma or equivalent qualification in a relevant discipline, and have at least two years of relevant experience; or 4) if they do not have any of the above qualifications, demonstrate at least five years of direct management experience in pharmaceutical wholesale, distribution or manufacturing. All RP candidates must attend an interview with the Pharmacy and Poisons Board (PPB) to assess their professional knowledge and ability.

📘 Regulatory basis

The Drug Office’s Guidance on the Requirements for a Responsible Person sets out the education, experience and competence standards for an RP. It is a key reference for the PPB interview assessment.

📗 Drew Tang's recommendations

The RP's CV is one of the most important parts of the application documents. We recommend that clients describe the RP's previous responsibilities in detail, particularly experience related to pharmaceutical procurement, quality control, inventory management and regulatory affairs. We provide the RP with professional pre-interview coaching covering Hong Kong pharmaceutical regulations, GDP knowledge and common interview questions to improve the chances of passing.

📕 Risk notice

If the nominated RP performs poorly at interview and fails to demonstrate a sufficient understanding of Hong Kong’s pharmaceutical regulations, the PPB will require the company to nominate a replacement, which will extend the application period indefinitely. Misrepresenting the RP’s qualifications or work experience is a serious breach of trust and will result in the application being refused immediately, and may affect the company’s integrity record in the future.

Q105 · 如果公司的负责人员（RP）或注册药剂师离职，公司需要履行哪些法律义务？独立链接

Maintaining qualified key personnel is an ongoing responsibility of the licence holder. If the company’s RP or a registered pharmacist working in a pharmacy or medicines manufacturing premises leaves, the company must act immediately. Under the requirements, the licence holder must notify the Drug Office in writing within a reasonable time after the event (usually recommended within 24 hours). More importantly, the company must immediately seek and appoint a qualified replacement. Until a permanent replacement is found, the company may need to suspend some affected licensed activities. For example, a pharmacy cannot sell prescription medicines or regulated medicines when no pharmacist is on duty. The company must submit details of the newly appointed person to the Drug Office for approval within the specified period (usually within one month).

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138) and the relevant Codes of Practice provide that licence holders are responsible for ensuring that they meet the licensing conditions at all times, including having qualified key personnel. The notification requirement for personnel changes is part of the licence conditions.

📗 Drew Tang's recommendations

We strongly recommend that clients establish backup and succession plans for key personnel. Working with a professional consultancy such as ours can enable recruitment to be initiated quickly, or temporary compliance support to be provided, if a key person leaves unexpectedly. This helps ensure business continuity and guides you through all necessary regulatory reporting procedures.

📕 Risk notice

Failure to notify the Drug Office promptly or continuing operations without a qualified person is a serious breach. The Drug Office may take disciplinary action, including issuing a warning letter, suspending the licence or, in extreme cases, revoking it. This is an absolute red line that the regulatory authority will not tolerate.

Q106 · 申请药房牌照（获授权毒药销售商），是否必须聘请一名全职的注册药剂师？独立链接

Yes, this is an absolute requirement. Under Hong Kong law, any entity wishing to operate a pharmacy (that is, an “Authorised Seller of Poisons (ASP)”) must employ at least one Hong Kong registered pharmacist. The pharmacist is not merely an employee, but the pharmacy’s “superintendent pharmacist”, personally supervising its day-to-day operations and medicine sales. This means the pharmacist must be present at the pharmacy during its business hours, personally handle and check doctors’ prescriptions, and supervise the sale of all controlled medicines (Part I poisons). The pharmacist’s name and registration certificate must be displayed prominently in the pharmacy. Inspectors from the Drug Office conduct unannounced inspections to ensure that the pharmacist is on duty.

📘 Regulatory basis

Section 3 of the Pharmacy and Poisons Regulations (Cap. 138A) expressly provides that the business of an Authorised Seller of Poisons must be “personally managed and conducted at the relevant premises” by a registered pharmacist. This is the Pharmacy Licence’s most fundamental statutory requirement.

📗 Drew Tang's recommendations

When preparing to open a pharmacy, recruiting a suitable registered pharmacist should be your top priority. The pharmacist's employment contract should clearly specify their responsibilities as the “pharmacist supervising the sale of poisons” and their hours of attendance at the pharmacy. RGYS may assist with organising roles, qualification evidence and responsibility arrangements within the written scope; candidate suitability, appointment and actual attendance in the role must still be verified by the applicant and legally qualified personnel. No provision of personnel or certification is promised. RGYS may assist with organising roles, qualification evidence and responsibility arrangements within the written scope; candidate suitability, appointment and actual attendance in the role must still be verified by the applicant and legally qualified personnel. No provision of personnel or certification is promised. We also ensure that their qualifications meet regulatory requirements.

📕 Risk notice

The so-called ‘nominal appointment’ of a pharmacist—where a pharmacist is merely listed but does not actually supervise the pharmacy on site—is a serious offence. If discovered by the Drug Office, this may result in the pharmacy licence being revoked immediately. The pharmacist concerned may also face disciplinary proceedings and could have their registration suspended or cancelled. Both the operator and the pharmacist may face criminal prosecution.

Q107 · 药剂业及毒药管理局（PPB）的面试主要考察申请人哪些方面的能力？独立链接

An interview with the Pharmacy and Poisons Board (PPB) is a key review stage in the licence application process, particularly for the Person-in-Charge (RP) of a wholesaler licence and key personnel of a manufacturer licence. The main purpose of the interview is to assess whether the nominees genuinely have the professional knowledge and ability to supervise and manage medicine-related activities. Topics generally cover five core areas: 1) understanding of Hong Kong laws and regulations relating to medicines, such as the Pharmacy and Poisons Ordinance and the Import and Export Ordinance; 2) knowledge of Good Distribution Practice (GDP) or Good Manufacturing Practice (GMP); 3) ability to handle practical scenarios, such as managing a medicine recall, identifying and reporting counterfeit medicines, and managing the supply chain; 4) professional knowledge of the medicines covered by the application; and 5) personal responsibility and integrity.

📘 Regulatory basis

The PPB's power to conduct interviews derives from its discretion under the Pharmacy and Poisons Ordinance (Cap. 138) to ensure that licence holders and their key employees are “fit and proper persons”. Interviews are an important means of assessing this standard.

📗 Drew Tang's recommendations

Do not underestimate the PPB interview. Our services for clients include comprehensive interview coaching. Based on the licence type and business scope in the application, we simulate a real interview, conduct question-and-answer practice and provide targeted suggestions for improvement, helping the RP answer confidently and accurately and demonstrate professional competence.

📕 Risk notice

A poor interview is a common cause of delay or failure. If the RP shows a lack of knowledge of the law or takes their responsibilities lightly during the interview, the PPB may not only reject the nominee but also question the applicant company’s overall integrity and competence, making subsequent scrutiny more difficult.

Q108 · 申请药品相关牌照时，监管机构对申请人或公司董事的“诚信”和“品格”有什么具体要求？独立链接

The regulatory authority has very high expectations of the integrity and character of applicants, company directors and key management personnel (the ‘fit and proper’ standard). This is not a vague concept; it is assessed against a series of specific criteria. First, applicants must disclose whether they have any criminal convictions, particularly for offences involving fraud, dishonesty or violence. Second, they must declare whether they have been convicted or received administrative penalties in Hong Kong or elsewhere for breaching laws relating to medicines, health products or trade. The authority will also consider whether they have been a director or senior officer of a company whose licence was revoked or whose application was refused, and whether they have been declared bankrupt or disqualified as a company director. The regulatory authority will verify these matters through background checks, criminal record checks and industry sources.

📘 Regulatory basis

The “Fit and Proper Person” test is a core power conferred on the PPB by the Pharmacy and Poisons Ordinance (Cap. 138). Although no single provision defines it in detail, its standards are now well established through numerous cases and guidelines.

📗 Drew Tang's recommendations

Integrity is a non-negotiable baseline. We recommend that all clients conduct internal due diligence on every director and key person they intend to nominate before starting an application. Any potential concerns regarding integrity should be disclosed to us proactively and candidly, so that we can assess their impact and develop the best notification strategy. Proactive disclosure with a reasonable explanation is far better than having the matter uncovered later.

📕 Risk notice

Providing false or misleading information during the application process is one of the actions least tolerated by the regulatory authorities. If an applicant is found to have deliberately concealed a criminal record or history of non-compliance, the application will be refused immediately, and the company and relevant individuals may find it difficult to obtain any type of financial or health-related licence in Hong Kong for a long time to come.

Q109 · 如果我之前在海外有过轻微的商业纠纷，会影响我在香港申请药品牌照吗？独立链接

This depends on the nature and severity of the commercial dispute and whether it involved dishonesty. Not every commercial dispute will be an obstacle to a licence application. Regulatory authorities are primarily concerned with incidents that may reflect on an applicant’s integrity, character and business conduct. If the dispute was an ordinary contractual disagreement resolved through negotiation or civil proceedings, and did not involve dishonest conduct such as fraud, document forgery or deliberate misrepresentation, its impact on a licence application is usually limited. However, you must proactively and fully disclose the matter in the relevant section of the application form. You should prepare the relevant legal documents, settlement agreement or court judgment, together with a clear explanation of the circumstances and final outcome.

📘 Regulatory basis

When assessing whether a person is ‘fit and proper’, the PPB will consider ‘all relevant matters’ concerning the applicant. This includes civil litigation and commercial disputes, particularly those that may affect the person’s ability to discharge the responsibilities of a licence holder. The key issue is whether the matter calls the person’s integrity into question.

📗 Drew Tang's recommendations

The best strategy for handling this kind of issue is to be proactive, candid and transparent. Do not take the chance of assuming that overseas records will not be discovered. We recommend preparing a detailed explanation that sets out the facts objectively and emphasises that the incident is unrelated to your professional competence or integrity in the pharmaceutical industry. We can help review the explanation to ensure that it is professionally worded and sincere in tone.

📕 Risk notice

The risk of failing to disclose an issue is far greater than the risk posed by the issue itself. If the regulator discovers undisclosed commercial disputes through its own channels, it may conclude that you lack integrity, which is far more serious than the disputes themselves. This lack of candour is almost certain to result in your licence application being refused.

Q110 · 申请“列载毒药销售商”牌照（例如在便利店或超市卖药），对店员有什么资格要求？独立链接

An LSP licence allows businesses such as convenience stores, supermarkets and personal care shops to sell Part II poisons (commonly called “P2 medicines”, such as some painkillers and cold medicines). The legal qualification requirements for sales staff are relatively less stringent, but there are clear rules. First, staff selling these medicines must be at least 18 years old. Second, and most importantly, the licence holder must ensure that all staff responsible for selling Part II poisons have received appropriate training. Training should cover how to identify Part II poisons, understand the legal restrictions on their sale (such as not selling them to anyone under 18), store the medicines, and advise customers to seek professional advice from a pharmacist or doctor when they make enquiries. The licence holder must keep all relevant staff training records for inspection by Drug Office inspectors at any time.

📘 Regulatory basis

Section 19 of the Pharmacy and Poisons Regulations (Cap. 138A) provides that persons selling Part II poisons must be at least 18 years old. The Code of Practice for Listed Sellers of Poisons further requires licence holders to provide staff with adequate training and keep records.

📗 Drew Tang's recommendations

We recommend that clients establish standardised training procedures and a manual for employees. Training should be conducted at least annually, with induction training for new employees. We will assist clients in designing training materials covering medicine classification, key sales considerations, legal responsibilities and emergency response, and provide training record templates. 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.

📕 Risk notice

If a Drug Office inspector finds during an inspection that shop staff know nothing about the legal requirements for the medicines they sell, or that the licence holder cannot produce any staff training records, this will be regarded as a serious breach. The regulator may fine the shop or even temporarily suspend its eligibility to sell the medicines concerned.

Q111 · 申请中成药制造商牌照，对“获授权人”（AP）的资格有什么特殊要求吗？独立链接

Yes, the qualifications for the Authorised Person (AP) of a proprietary Chinese medicine manufacturer are distinct from those for a western medicine manufacturer. Under the Chinese Medicine Council of Hong Kong (CMCC) guidelines, the qualifications for an AP of proprietary Chinese medicines are more flexible to reflect the characteristics of the Chinese medicine industry. The nominee will generally need one of the following backgrounds: 1) a registered Chinese medicine practitioner in Hong Kong; 2) a pharmacist who has taken courses related to Chinese medicines; 3) a degree in Chinese pharmacy, Chinese medicine, pharmacy or a related discipline; or 4) at least 10 years' extensive experience in the manufacture, quality control or research and development of proprietary Chinese medicines. Whatever their background, the AP must demonstrate to the Chinese Medicines Board that they have a thorough understanding of Good Manufacturing Practice (GMP) for proprietary Chinese medicines and can supervise the entire production process to ensure product safety, efficacy and consistent quality.

📘 Regulatory basis

The Chinese Medicine Ordinance (Cap. 549) and the subsidiary Guidelines on Good Manufacturing Practice for Proprietary Chinese Medicines set out the framework for the AP’s responsibilities and qualifications. In assessing an application, the Chinese Medicines Board will evaluate the nominee’s education, experience and professional knowledge as a whole.

📗 Drew Tang's recommendations

When looking for a suitable AP for a proprietary Chinese medicine manufacturer, the key is their depth of understanding of Chinese medicine. We recommend prioritising candidates with practical GMP management experience at a Chinese medicine manufacturer. In the application, highlight their knowledge and experience in identifying Chinese herbal medicines, processing techniques and quality standards (such as controlling heavy metals and pesticide residues).

📕 Risk notice

It is difficult to pass the Chinese Medicines Board’s review if an Western medicines expert with no knowledge of Chinese medicines is nominated as the AP. If the AP cannot identify genuine, authentic and good-quality Chinese herbal medicines, or does not understand the principles of traditional processing methods, they may be considered unsuitable for the role, causing delays to the application.

Q112 · 我是一家海外的药品生产商，想在香港申请牌照，是否必须在香港设立一家子公司？独立链接

Yes, this is necessary. Under the Companies Ordinance (Cap. 622), any overseas company wishing to carry on business in Hong Kong must register as a “registered non-Hong Kong company”. However, registration as a non-Hong Kong company alone is generally insufficient when applying for licences such as those for pharmaceutical wholesalers, manufacturers or pharmacies. The regulator (the Drug Office, Department of Health) requires the licence holder to be a legal entity incorporated in Hong Kong, namely a Hong Kong-incorporated limited company. This is because the regulator needs to oversee and enforce the law against an entity with a clear legal status and assets in Hong Kong. Accordingly, the standard approach is for the overseas company first to incorporate a wholly owned or joint venture local limited company in Hong Kong, and then submit the licence application in the name of that Hong Kong company.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance (Cap. 138) requires licence holders to be entities with an actual business presence in Hong Kong. In practice, the Drug Office generally requires applicants to be limited companies incorporated in Hong Kong under the Companies Ordinance, to facilitate jurisdiction and accountability.

📗 Drew Tang's recommendations

We provide overseas clients with a one-stop service, from establishing a Hong Kong limited company to preparing a business plan, finding compliant business premises, recruiting key personnel, submitting a licence application and communicating with the regulatory authorities. Establishing a local company is the first and most critical step in the overall compliance setup.

📕 Risk notice

Applications made directly in the name of an overseas parent company, or through a registered non-Hong Kong branch alone, will be refused because the applicant does not meet the eligibility requirements. This would waste considerable time and resources. You must strictly follow regulatory requirements and use a locally incorporated Hong Kong company as the applicant entity.

Q113 · 申请药品牌照时，对公司的注册资本有最低要求吗？独立链接

Hong Kong company law does not set a minimum share capital for companies; in theory, it can be as low as HK$1. In practice, however, although there is no specified statutory minimum share capital for a pharmaceutical licence application, the amount is an important reference point for regulators assessing a company's financial soundness. A very low share capital, such as only a few thousand Hong Kong dollars, may lead regulators to question whether the company has sufficient financial resources to support its normal business operations, including paying rent and staff salaries, purchasing medicines and dealing with possible unexpected events such as a medicine recall. Therefore, although the law does not specify a minimum, having reasonable share capital proportionate to the scale of the business is advisable from an application strategy perspective.

📘 Regulatory basis

Although the Pharmacy and Poisons Ordinance does not expressly prescribe registered capital, it requires licence holders to be capable of maintaining ongoing compliant operations. Financial soundness is evidence of this capacity, and registered capital is one indicator used to assess financial standing.

📗 Drew Tang's recommendations

We generally recommend that clients set a reasonable registered capital based on the financial projections in their business plan. For example, registered capital of HKD 500,000 to HKD 1,000,000 is a fairly common level for a medium-sized pharmaceutical wholesaler and is generally acceptable to the regulatory authorities. This demonstrates the shareholders' commitment to the business and financial strength.

📕 Risk notice

Setting registered capital too low may lead regulators to question the company's financial capacity and request additional financial evidence, such as bank deposit certificates or shareholder undertakings, thereby slowing the approval process. This is a case of “saving a little and losing a lot”.

Q114 · 如果我提名的负责人员（RP）是外籍人士，持有海外的药剂师资格，是否被认可？独立链接

This depends on the circumstances. First, if the foreign national wishes to practise in Hong Kong as a “registered pharmacist” (for example, by working in a pharmacy), their overseas pharmacist qualification must first pass the qualification examination of the Pharmacy and Poisons Board (PPB) of Hong Kong, and they must complete the local internship requirements. They can only be recognised after successful registration. Second, if the person is to serve as the “Responsible Person (RP)” for a pharmaceutical wholesaler or manufacturer, rather than in a position that is legally required to be held by a pharmacist, their overseas degree in pharmacy and relevant experience will be taken into account. However, they must still satisfy the PPB that they are fully familiar with and understand Hong Kong’s local pharmaceutical regulatory requirements. Therefore, even with overseas qualifications, they must prepare thoroughly for the PPB interview by acquiring localised knowledge.

📘 Regulatory basis

The Pharmacists Registration Ordinance (Cap. 151) sets out stringent requirements for the registration of overseas pharmacists in Hong Kong. Although the Drug Office guidance recognises degrees in relevant disciplines for RP qualifications, knowledge of local regulations is a key focus at interview.

📗 Drew Tang's recommendations

For RP candidates with overseas qualifications, we strongly recommend attending the systematic regulatory training we provide. We will help them quickly understand the framework and key aspects of Hong Kong's pharmaceutical regulation, understand its similarities to and differences from those of the EU, the US and other jurisdictions, and conduct multiple mock interviews. 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.

📕 Risk notice

Relying solely on overseas experience and qualifications when attending a PPB interview is very risky. Interviewers will ask specifically about Hong Kong legal details, such as the classification of medicines, labelling requirements and import/export procedures. A lack of familiarity with the local context is a major reason for interview failure.

Q115 · 申请中药材零售商牌照，对从业人员有什么具体要求？是否需要中医师资格？独立链接

The requirements for personnel working for a Chinese herbal medicine retailer differ from those for a Western medicine pharmacy. There is no mandatory requirement to have a registered Chinese medicine practitioner on the premises. However, the law requires one person to be responsible for supervising the business at a Chinese herbal medicine retail shop. This supervisor must have specific knowledge and experience in Chinese herbal medicines. Under the requirements of the Chinese Medicine Council of Hong Kong, the person must meet one of the following conditions: 1) be a registered or listed Chinese medicine practitioner; 2) have successfully completed a training course in retail of Chinese herbal medicines recognised by the Chinese Medicine Council of Hong Kong; or 3) have engaged continuously in the retail of Chinese herbal medicines for at least 10 years before the Chinese Medicine Ordinance came into effect. This means that a person who is not a Chinese medicine practitioner may still qualify as a supervisor by completing a recognised training course and obtaining a certificate.

📘 Regulatory basis

Section 115 of the Chinese Medicine Ordinance (Cap. 549) and the Chinese Medicines Regulation set out in detail the qualification requirements for supervising personnel of retailers of Chinese herbal medicines. These are key areas for licensing and routine inspections by the Chinese Medicines Board.

📗 Drew Tang's recommendations

For a newly opened retail Chinese herbal medicine shop, the most direct and effective approach is to arrange for one or more key employees to attend a training course recognised by the Chinese Medicine Council of Hong Kong. These courses are usually provided by local universities or professional institutions. We will provide clients with the latest course information and assist employees with enrolment to ensure that they obtain the necessary qualifications before the business opens.

📕 Risk notice

Do not assume that hiring any long-serving employee will satisfy the requirements. If the employee cannot provide legally required proof of qualifications (such as Chinese medicine practitioner registration, training certificates or evidence of sufficient years of experience), the shop may face a fine or even suspension of operations until a suitably qualified person is hired, if this is discovered by an inspector of the Chinese Medicines Board.

Q116 · 在背景审查中，哪些类型的刑事记录会对药品牌照申请构成“一票否决”？独立链接

When assessing whether an applicant is ‘fit and proper’, certain types of criminal record are almost insurmountable obstacles and are highly likely to result in an automatic refusal. These records primarily relate to offences directly connected with integrity, professional conduct and public safety. They include: 1) offences involving dishonesty, such as theft, fraud, document forgery, corruption or bribery; 2) serious medicine-related offences, such as the illegal manufacture, trafficking or supply of dangerous drugs; 3) serious violent offences; and 4) convictions in Hong Kong or another jurisdiction for serious breaches of medicine manufacturing or distribution regulations. If a director or key manager of the applicant company has any of these convictions, the regulatory authorities are highly likely to consider that they lack the integrity and sense of responsibility required to operate a medicine business and refuse the licence application.

📘 Regulatory basis

In exercising its discretion, the PPB scrutinises applicants' criminal records. Although the law does not specify offences that automatically result in rejection, case law and regulatory practice indicate that offences involving dishonesty or a serious threat to public health are red lines of particular concern.

📗 Drew Tang's recommendations

We strongly recommend conducting thorough background checks on all key personnel to be nominated before formally submitting an application. If any records are found that may give rise to concern, seek professional legal advice immediately to assess their potential impact on the application. In some cases, replacing the candidate may be the only viable option.

📕 Risk notice

Attempting to conceal a serious criminal conviction is one of the most fatal mistakes in the application process. The regulatory authority has various means of checking, including requiring the applicant to authorise a check of their certificate of no criminal conviction. If concealment is discovered, the application will be refused and a record of dishonesty will be left, with long-term negative effects on the future development of both the individual and the company.

Q117 · 公司的一名董事曾经破产，但现在已经解除了破产令，这是否会影响公司申请药品牌照？独立链接

This is an issue that needs to be handled carefully. A director’s history of bankruptcy is one of the factors that regulatory authorities may consider when assessing whether they are a “fit and proper person”, as it may reflect their financial management ability and business judgement. However, if the director has been formally discharged from bankruptcy and can provide a certificate of discharge issued by the court, the negative impact will be greatly reduced. In this situation, it is important to explain the matter to the regulatory authorities proactively and clearly. The application documents should include a statement explaining the reason for the bankruptcy (for example, whether it resulted from a sudden change in market conditions rather than personal misconduct), when it occurred, and how the director handled their financial obligations during and after the bankruptcy. Demonstrating that the incident was a one-off, has been properly resolved and has provided the director with lessons is key to reassuring the regulatory authorities.

📘 Regulatory basis

The “Fit and Proper Person” assessment is comprehensive, and a past bankruptcy record forms part of “all relevant matters”. The regulator is concerned with whether the record suggests that the applicant may be unable to manage the licensed business’s finances prudently.

📗 Drew Tang's recommendations

We recommend that clients prepare detailed explanatory materials together with all supporting documents, such as a discharge from bankruptcy and proof of debt repayment. The explanation should emphasise that the director’s current financial position is sound and that the company has sufficient operating funds, which will not be affected by the director’s past personal financial difficulties. A strong business plan and financial projections can also provide valuable support.

📕 Risk notice

The worst thing to do is try to conceal or downplay the matter. The regulator can easily discover bankruptcy records through public records and background checks. If dishonesty in disclosure is discovered, the regulator will question the integrity of the entire management team, with consequences far more serious than the bankruptcy record itself.

Q118 · 申请药品制造商牌照，除了AP外，对质量控制（QC）部门的负责人有什么资格要求？独立链接

In the application for and operation of a pharmaceutical product manufacturer licence, the Head of the Quality Control (QC) department has a vital role, and their qualifications directly affect whether products can consistently meet quality standards. Under PIC/S Good Manufacturing Practice (GMP), the QC Head must be independent of the production department and report directly to management. Qualification requirements generally include: 1) a university degree in pharmacy, chemistry, biology, microbiology or a related scientific field; 2) several years’ practical experience in pharmaceutical quality control and familiarity with analytical techniques and operating instruments such as HPLC and GC; 3) a thorough knowledge of GMP regulations, particularly requirements relating to laboratory management, sampling, stability testing, documentation and deviation investigations; and 4) the ability to manage a QC team and ensure that all tests are accurately performed using validated methods.

📘 Regulatory basis

Chapter 2, “Personnel”, of the Hong Kong Good Manufacturing Practice (PIC/S GMP) Guide for Pharmaceutical Products expressly sets out the duties and qualification requirements of key personnel, including the heads of production and quality control. The head of QC must have appropriate qualifications and experience.

📗 Drew Tang's recommendations

We recommend that clients begin recruiting an experienced QC lead at the early planning stage of a pharmaceutical factory. This person should understand not only the technical aspects but also GMP management. Their detailed CV and achievements in establishing and managing a QC laboratory will be strong supporting evidence when applying for the licence.

📕 Risk notice

Appointing an underqualified or inexperienced person as QC head is a major risk in pharmaceutical manufacturing. If the QC department cannot function effectively, non-conforming raw materials may be used or finished products with quality issues may be released. If this is discovered by the regulator or results in market complaints, the consequences may be disastrous, including a mandatory recall, suspension of production or licence revocation.

Q119 · 我计划成立一家只做药品进出口贸易，不在香港进行实体销售的公司，是否还需要为负责人员（RP）安排面试？独立链接

Yes, this is absolutely required. If you are applying for a Wholesale Dealer Licence, you must nominate a qualified Responsible Person (RP), regardless of whether your business model is purely import/export trading (so-called “trans-shipment trade”) or includes local distribution. The RP must also pass an interview with the Pharmacy and Poisons Board (PPB). This is because, even when medicines are not physically sold in Hong Kong, their storage, trans-shipment and documentation in Hong Kong are still strictly regulated under Hong Kong's medicines legislation. The RP is responsible for ensuring that these activities fully comply with the requirements and for preventing counterfeit or substandard medicines from entering global markets through Hong Kong's trading system. The PPB therefore uses the interview to confirm that the RP has the knowledge and ability required to supervise these activities.

📘 Regulatory basis

The licence conditions for any entity holding a Wholesale Dealer Licence require an RP accepted by the PPB. The business scope (local distribution or import/export) may affect the emphasis of the interview, but does not exempt the applicant from the interview itself.

📗 Drew Tang's recommendations

For clients specialising in import and export, our RP interview coaching places particular emphasis on relevant laws and operational practices, such as the application process for import and export licences, requirements for the transit and storage of medicines in Hong Kong, the application of Good Distribution Practice (GDP) to trading activities, and handling customs inspections. This helps RPs give more focused and professional answers in interviews.

📕 Risk notice

Do not assume that “trading only, with no involvement in the local market” means you can apply lower compliance standards. As a free port, Hong Kong also strictly regulates the re-export trade in medicines. If the RP demonstrates ignorance of import and export regulations at an interview, the PPB may consider that the company cannot effectively manage supply-chain risks and refuse its licence application.

Q120 · 申请药品牌照的公司，其董事会成员中是否必须有具备医疗或药学背景的人？独立链接

There is no explicit legal requirement for a company’s board of directors to include members with medical or pharmaceutical backgrounds. The applicant is the corporate entity, and the regulator’s core requirement is that the company engages qualified key technical personnel, such as a Responsible Person (RP), registered pharmacist and Authorised Person (AP), who are responsible for and supervise licensed activities. However, from the perspective of corporate governance and risk management, having a board member with a relevant professional background is undoubtedly an advantage. It signals to the regulator that the company’s senior decision-makers can understand and assess the risks specific to the pharmaceutical industry and are better placed to support and oversee the company’s compliant operations.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance focuses on the qualifications of professionals involved in operations, rather than the composition of the board of directors. However, when assessing a company’s overall “suitability”, the PPB may consider its governance structure; the board’s professional competence is one qualitative indicator.

📗 Drew Tang's recommendations

If most members of your board lack a pharmaceutical background, we recommend considering the establishment of a “scientific or compliance advisory committee” comprising external experts, such as experienced pharmacists, doctors or industry consultants. This can provide the board with professional decision-making support and demonstrate to the regulatory authority, when applying for a licence, the company's commitment to professional standards.

📕 Risk notice

A board made up entirely of people with commercial or financial backgrounds may prompt the regulator to question its ability to manage the risks of a pharmaceutical business, if the application materials and business plan do not clearly explain how the board will manage and oversee the specialist technical team. This will not directly result in a refusal letter, but may lead to further and more in-depth enquiries.

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