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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Q141 · 一家公司是否可以同时持有多种类型的药品牌照，例如同时持有批发商和制造商牌照？独立链接

Yes. A company may apply for and hold more than one pharmaceutical licence, depending on its business needs. For example, a company that manufactures medicines and also sells them to other wholesalers, hospitals or pharmacies must hold both a manufacturer’s licence and a wholesaler’s licence. Similarly, a company may hold licences for both wholesale of proprietary Chinese medicines and wholesale of Western medicines. The key is that the company must meet the relevant statutory requirements for every licensed activity. This means that if it holds two types of licence, its facilities, personnel, Quality Management System and operating procedures must meet the regulatory standards for both licences, and it must be able to clearly demonstrate compliant operations under each licence during inspections.

📘 Regulatory basis

The Pharmacy and Poisons Ordinance regulates by “activity”. Each regulated activity (such as manufacture, wholesale or retail) requires a separate licence. The law does not prohibit the same legal entity from holding multiple licences, provided it can meet the conditions of each licence.

📗 Drew Tang's recommendations

For clients planning to diversify their business, we recommend identifying all the licensed activities involved at the outset of business planning. We can assist with a comprehensive compliance gap analysis to ensure that your premises layout, staffing and SOP documents meet the requirements for all applications together, enabling the most efficient application process.

📕 Risk notice

Holding multiple licences entails multiple compliance responsibilities. The company must ensure that different business activities are clearly separated and managed; for example, materials in the production area must not be confused with finished goods in the wholesale area. A serious violation under any one licence may affect the standing and validity of the company’s other licences.

Q142 · 对于需要冷链运输和储存的药品（如疫苗），对相关操作人员有何特殊的资格或培训要求？独立链接

Personnel handling medicines that require cold chain management (Cold Chain Products) are subject to stringent training and qualification requirements set by the regulatory authorities. All employees involved in receiving, storing, packing, transporting and distributing cold chain medicines must receive specific training. The training must cover: 1) the basic principles and importance of the cold chain; 2) the specific temperature requirements for different medicines (such as 2-8°C); 3) how to use and read temperature monitoring equipment correctly (such as data loggers); 4) the correct use of cold chain packaging (such as cool boxes and cool packs); 5) emergency procedures for temperature excursions; and 6) relevant record-keeping and documentation requirements. The person overseeing cold chain operations (usually the RP or their delegate) needs more in-depth knowledge to be able to validate the effectiveness of cold chain equipment and processes.

📘 Regulatory basis

The World Health Organization (WHO) and PIC/S Good Distribution Practice (GDP) annexes both contain dedicated sections on cold-chain products. The Code of Practice for Authorized Persons, Listed Sellers of Poisons and Listed Sellers of Poisons must also be observed by licence holders, who must ensure that medicines are stored under suitable conditions throughout the supply chain.

📗 Drew Tang's recommendations

We strongly recommend that clients operating cold-chain medicines make cold-chain management a core part of their Quality Management System (QMS). We can help clients draft a complete set of cold-chain SOPs, design staff training and assessment programmes, and recommend qualified cold-chain equipment and validation service providers to ensure that your cold-chain operations are robust.

📕 Risk notice

A break in the cold chain can be fatal to pharmaceutical product quality. A brief temperature excursion may render an entire batch of high-value vaccines or biological products ineffective, causing not only significant financial losses but also potential harm to public health. During regulatory inspections, cold-chain management records and implementation are a major focus, and any deficiency may have serious consequences.

Q143 · 如果持有药品牌照的公司发生了重大的股权变更，例如被另一家公司收购，是否需要重新申请牌照？独立链接

This depends on the circumstances, but a completely new application is generally not required; instead, strict notification and approval procedures must be followed. When a licensed company undergoes a major shareholding change or transfer of control, the legally licensed entity (that is, the company as a legal person) remains unchanged, so the licence itself remains valid. However, the company must immediately notify the Drug Office, Department of Health, in writing of this major change. The new major shareholders, directors and ultimate beneficial owners must submit their personal particulars to the Pharmacy and Poisons Board (PPB) and undergo a “fit and proper person” assessment. The PPB must be satisfied that, under the new control, the company can and will continue to comply with all licence conditions. In some cases, if the PPB has concerns about the new shareholders’ background or intentions, it may impose additional licence conditions or conduct inspections more frequently.

📘 Regulatory basis

Licence conditions generally require notification to the regulator of any significant change that may affect the company’s control. This is to ensure that the PPB can continue to discharge its statutory duty to supervise the ‘fitness’ of licence holders.

📗 Drew Tang's recommendations

Before any merger and acquisition or major share transaction, we strongly recommend that both buyer and seller make regulatory approval one of the key conditions precedent to completion. We will help the new shareholders prepare the full set of notification documents and proactively communicate with the Drug Office to explain the commercial rationale for the transaction and the future operating plan, with a view to securing a smooth approval process.

📕 Risk notice

“Act first and notify later”—that is, notifying the regulator only after completing a share transaction—is an extremely wrong and dangerous approach. It may be seen as disregard for regulatory requirements and could seriously call into question the integrity of the new management. In the worst-case scenario, if a new shareholder is found not to be a “Fit and Proper Person”, the PPB has the power to initiate licence revocation proceedings.

Q144 · 处理细胞毒性药物或其他危险药品的人员，需要具备哪些特殊的资格和防护培训？独立链接

Personnel handling hazardous drugs such as cytotoxic drugs must receive more stringent and specialised training than personnel handling ordinary drugs. Their qualifications and training are essential to occupational safety and the prevention of environmental contamination. Training must cover: 1) the characteristics and potential hazards of hazardous drugs (such as carcinogenicity and teratogenicity); 2) the correct selection and procedures for putting on and removing personal protective equipment (PPE), such as double gloves, protective gowns, goggles and respiratory protective equipment; 3) procedures for handling hazardous drugs in a dedicated negative-pressure isolator or biological safety cabinet; 4) emergency procedures for accidental spills and exposure incidents; and 5) the correct classification, labelling and handling of hazardous drug waste. Only employees who have completed the training and passed the assessment may be authorised to handle these high-risk products.

📘 Regulatory basis

The PIC/S GMP Guide and international occupational health and safety standards (such as OSHA and NIOSH) provide detailed guidance on the safe handling of hazardous medicines. During inspections, the Drug Office, Department of Health scrutinises whether licence holders follow these best-practice standards.

📗 Drew Tang's recommendations

We recommend that clients handling these products invest in suitable engineering control equipment (such as isolators) and establish a separate SOP for the safe handling of hazardous medicines. We will help clients design a comprehensive training programme covering both theoretical knowledge and practical exercises, and establish a strict authorisation system for staff to perform the work.

📕 Risk notice

Failure to provide staff with adequate training in the handling of dangerous drugs is a serious dereliction of responsibility for their life and health, as well as a major legal risk. If an employee’s health is harmed through occupational exposure, the company may face substantial compensation claims and legal proceedings, and the regulatory authority may also revoke its authorisation to handle the relevant medicines.

Q145 · 药剂业及毒药管理局（PPB）对申请人的背景审查范围有多广？会调查海外记录吗？独立链接

The PPB's background checks on key applicants (such as directors, UBOs and RPs) are extensive and in-depth, and are by no means limited to Hong Kong. The purpose is to assess comprehensively whether the person meets the “fit and proper” standard. Checks typically include: 1) identity verification; 2) criminal record checks (the applicant may be asked to authorise a criminal record certificate check); 3) checks of bankruptcy and company director disqualification records; 4) searches of publicly available information, including news reports and social media; and 5) verification of the applicant's declared academic and professional qualifications. For applicants with overseas backgrounds, the PPB may require overseas criminal record certificates and will pay particular attention to any adverse records with regulatory authorities in other countries, whether in medicines, finance or other sectors. Although cross-border checks can be complex, applicants are responsible for providing all relevant information and documents as requested.

📘 Regulatory basis

The PPB's discretion allows it to require an applicant to provide “any further information as it may consider appropriate” to help it determine whether the applicant is a “fit and proper person”. This provides a legal basis for extensive background checks.

📗 Drew Tang's recommendations

We recommend that clients conduct an internal “mock background check” of all key personnel before starting the application, to identify potential risk factors proactively. Prepare official supporting documents and a clear explanation for any overseas records. Transparency and cooperation are the best ways to earn regulators’ trust.

📕 Risk notice

Do not assume that an overseas “black history” will go undetected. In today’s increasingly globalised and information-sharing environment, regulatory authorities’ investigative capabilities far exceed what you might imagine. Being found dishonest during a background check can have disastrous consequences, far more serious than any past blemish itself.

Q146 · 如果一个人曾是某家药品牌照被吊销的公司的董事，他还能在新的申请公司中担任董事吗？独立链接

This situation will be subject to very stringent scrutiny, and the chances of success are slim, but it is not absolutely impossible. If a person has served as a director of a company whose licence was revoked, the PPB will conduct an extremely thorough investigation when assessing their eligibility to serve as a director of a new company. The PPB will focus on the following points: 1) What were the specific reasons for the company’s licence being revoked? Did they involve serious dishonesty or a significant threat to public health? 2) What role did the director play in the events leading to the revocation? Did they actively participate, knowingly fail to report the matter, or genuinely have no knowledge of it while fulfilling their duties as a director? 3) Has the director shown any reflection or improvement since the events? They must be able to provide highly persuasive evidence that they have learned significant lessons and that the new applicant company has established robust checks and oversight mechanisms to prevent a recurrence.

📘 Regulatory basis

This is a typical case in a “fit and proper person” assessment. Past regulatory breaches are an important basis for assessing the risk of future conduct. The PPB’s primary duty is to protect the public, so it takes an extremely cautious approach to applicants in such cases.

📗 Drew Tang's recommendations

If this happens, your only hope lies in complete candour and compelling evidence. The applicant must prepare an extremely detailed statement explaining the events and their own responsibility. The new company's business plan and compliance framework must also be beyond reproach. Even so, you should be prepared for the application to be rejected. In many cases, replacing the director is the wiser choice.

📕 Risk notice

If the reason for licence revocation involves serious issues such as fraud or deliberately endangering the public, it is almost impossible for the relevant directors to pass the PPB's “fit and proper person” test again. Attempting to excuse such a history may be viewed as a lack of remorse and make the situation worse.

Q147 · 公司是否需要为负责人员（RP）或注册药剂师设立“后备”或“代理”人选？独立链接

There is no legal requirement to formally appoint a “deputy” or “stand-in” RP or pharmacist for a licence application or day-to-day operations. The statutory requirement is that a qualified, approved key person must be available at all times. However, from the perspective of sound operations and risk management, having an effective succession or temporary cover plan is highly advisable and professional. Large wholesalers or manufacturers commonly appoint a deputy or senior manager who has the potential qualifications to become an RP and is familiar with all relevant duties, so that they can take over promptly if the RP is on leave or leaves unexpectedly. A pharmacy cannot have two pharmacists-in-charge of sale at the same time, but it can establish contacts with locum pharmacists so that temporary cover can be arranged to maintain lawful operations if the pharmacist-in-charge is ill or on leave.

📘 Regulatory basis

The core regulatory requirement is “continuous availability”, not “appointing a designated deputy”. However, guidance such as the Code of Practice forholders of licences issued under the Pharmacy and Poisons Ordinance encourages licence holders to establish a sound Quality Management System, of which continuity of personnel management is one part.

📗 Drew Tang's recommendations

RGYS may assist with clarifying roles, evidence of qualifications and responsibility arrangements within the written scope; the suitability, appointment and actual presence at work of candidates remain subject to verification by the applicant and legally qualified personnel, and no provision or certification of personnel is promised. A potential backup RP can be involved in all relevant compliance meetings and training to ensure that he or she stays up to date. For pharmacies, a reliable contact list of locum pharmacists should be established. This demonstrates the company's management maturity and commitment to business continuity.

📕 Risk notice

The greatest risk of having no contingency plan is that, if a key person suddenly leaves or becomes unable to perform their duties, the company will immediately fall into a non-compliant state. Finding and appointing a new qualified person takes time. During this gap, the company may be forced to suspend all licensed activities, resulting in substantial business losses and customer attrition.

Q148 · 对于计划提供“远程药事服务”或“网上药房”业务，对相关人员有何特殊的资格要求？独立链接

Regulation of “remote pharmacy services” and “online pharmacies” in Hong Kong is still evolving. The core principle, however, is that any dispensing and sale of prescription medicines must take place under the direct supervision of a registered pharmacist and comply with all applicable pharmaceutical regulations. This means that even if a prescription is received through an online platform, the final review, dispensing, checking and supply of the medicine must be carried out in person by a registered pharmacist at physical premises holding a valid Authorised Seller of Poisons (ASP) (pharmacy) licence. Pharmacists responsible for online consultations must also be registered pharmacists in Hong Kong. In addition, the IT systems, data privacy safeguards and medicine delivery arrangements (particularly for cold-chain medicines) used throughout the process must be designed and managed by personnel with the relevant expertise to ensure that the service is safe, compliant and traceable.

📘 Regulatory basis

The Department of Health issued Guidelines on Ethical Practice in Telehealth in 2023, and the Pharmacy and Poisons Board also issued relevant guidelines. The key principle is that online services must not lower or circumvent any statutory standards applicable to physical pharmacies, particularly the pharmacist’s personal supervision responsibilities.

📗 Drew Tang's recommendations

For clients wishing to explore this innovative business, we recommend proceeding with extreme caution. First, you must have a fully compliant physical pharmacy as the operational foundation. We can help you design an online and offline workflow (SOP) that complies with regulatory guidance and ensure that your IT platform meets standards for patient privacy and data security.

📕 Risk notice

It is strictly prohibited in Hong Kong to attempt to operate a purely “virtual pharmacy” entirely without a physical pharmacy or pharmacist supervision, in order to sell prescription medicines. Any conduct that bypasses a pharmacist's prescription checks or dispatches medicines from an unlicensed location will be treated as illegal sales and unlicensed operation, and will attract the most severe legal penalties.

Q149 · 药品批发商的负责人员（RP）或药房的注册药剂师，是否必须是香港永久性居民？独立链接

Not necessarily. Hong Kong’s medicines regulatory legislation does not make Hong Kong permanent residency a statutory requirement for appointment as an RP or registered pharmacist. Any non-permanent resident holding a valid Hong Kong work visa may take on these key roles, provided that they meet the relevant professional qualification, academic and experience requirements and pass the regulatory authority’s review or approval (such as a PPB interview or pharmacist registration). For example, a pharmacist holding a foreign passport may be employed by a pharmacy if they pass the Hong Kong licensing examination and are successfully registered. Similarly, a foreign expert holding a work visa may be appointed as the RP of a medicine wholesaler if they have the required experience and knowledge. What matters is their professional competence and lawful work status, not their category of residency.

📘 Regulatory basis

Neither the Pharmacy and Poisons Ordinance nor the Pharmacists Registration Ordinance restricts the residency status of key personnel. Hong Kong’s Immigration Ordinance sets out the visa requirements for non-local residents working in Hong Kong.

📗 Drew Tang's recommendations

For clients wishing to employ overseas professionals in key positions, we provide a one-stop service. We not only help assess whether their professional qualifications meet the requirements for pharmaceutical licences, but also assist them in applying to the Immigration Department for an employment visa. We will prepare strong supporting documents explaining the necessity of the position and the candidate’s unique qualifications.

📕 Risk notice

When employing non-local residents, ensure that applications for their work visas and visa renewals are fully compliant. If a key person’s visa becomes invalid during the licence application or while the licence is held, preventing them from working lawfully in Hong Kong, the company will immediately become non-compliant, with the same consequences as if the key person had left.

Q150 · 为了维持资格，负责人员（RP）和注册药剂师是否有持续专业发展（CPD）的强制要求？独立链接

Yes, continuing professional development (CPD) is essential to maintaining the professional standards and qualifications of key personnel. The Pharmacy and Poisons Board (PPB) has implemented a mandatory CPD programme for registered pharmacists. Pharmacists must complete the prescribed number of CPD credits within a specified cycle (for example, three years) in order to renew their practising certificates. CPD activities take various forms, including attending academic lectures and seminars, completing online courses and publishing research. Although there is currently no mandatory credit system for RPs of pharmaceutical wholesalers and manufacturers as there is for pharmacists, “continuing training” is a basic requirement of Good Distribution Practice/Good Manufacturing Practice (GDP/GMP). Licensed companies are responsible for providing RPs with ongoing training on regulatory updates, new technologies and industry best practices, and for keeping all training records. During inspections, the regulatory authority will assess whether the RP's knowledge is up to date.

📘 Regulatory basis

The Pharmacy and Poisons Board website sets out the CPD requirements for registered pharmacists. The Code of Practice for the Guidance of Authorised Persons and GMP guidelines also emphasise the responsibility to provide “continuous training” for all key personnel.

📗 Drew Tang's recommendations

We recommend that all licensed companies establish annual training plans for key personnel and allocate budgets to support their participation in high-quality CPD activities. We also regularly hold seminars on regulatory updates and compliance topics to help our clients meet these evolving requirements and provide certificates of attendance for their records.

📕 Risk notice

For pharmacists, failure to complete CPD credits will directly prevent renewal of their practising certificates, resulting in loss of the right to practise. If an RP’s knowledge becomes outdated and fails to keep pace with regulatory and technical developments, they will be unable to perform their supervisory duties effectively. Regulatory authorities may regard this as a significant compliance risk that could affect the company’s licence renewal.

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