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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Q121 · 如果公司在申请牌照期间，提名的负责人员（RP）突然离职，应该怎么办？独立链接
This is a common but complex issue. Under Hong Kong law, a valid prescription must be issued by a doctor, dentist or veterinary surgeon registered in Hong Kong. Strictly speaking, therefore, a pharmacy / Authorised Seller of Poisons (ASP) in Hong Kong cannot lawfully dispense prescription medicines on the basis of a prescription issued by an overseas doctor, such as one from Mainland China, the United States or the United Kingdom. Even if the doctor is qualified to practise in their own country, a prescription signed by them has no legal effect in Hong Kong because they are not registered with the Medical Council of Hong Kong. A pharmacy that dispenses medicines on this basis would incur legal risks.
Q122 · 申请药房牌照，对店铺的法人代表（公司董事）和驻店药剂师可以是同一个人吗？独立链接
Yes. The law does not prohibit the owner of a pharmacy (that is, a company director or shareholder) from also serving as the pharmacy’s resident registered pharmacist, provided that person is themselves a qualified registered pharmacist in Hong Kong. In fact, this is very common in Hong Kong, where many community pharmacies are established and operated by pharmacists themselves. This ‘pharmacist-owner’ model may even be considered ideal, as it ensures that the pharmacy’s highest decision-maker has the most relevant pharmaceutical knowledge and a strong compliance mindset. In this situation, the pharmacist holds two roles: as a company director, they are responsible for the company’s overall operations and finances; as the pharmacist-in-charge of sales, they personally supervise the pharmacy’s medicines management and sales activities.
Q123 · 什么是“药物监控系统”（Drug Surveillance System）？申请批发商牌照的公司需要具备这样的系统吗？独立链接
A drug monitoring system, also known as a pharmacovigilance system, is a system for detecting, assessing, understanding and preventing adverse drug reactions (ADRs) and other medicine-related problems. For a medicine wholesaler, establishing and maintaining an effective drug monitoring system is part of its licence responsibilities. Although it may be less complex than a manufacturer’s system, a wholesaler’s system should include at least the following: 1) designated staff responsible for receiving and handling ADR reports from customers such as hospitals, pharmacies and doctors; 2) standard operating procedures (SOPs) for recording, assessing and promptly reporting received ADR information to the medicine manufacturer and the Drug Office, Department of Health; 3) the ability to assist manufacturers with medicine recalls; and 4) retention of all relevant records.
Q124 · 申请中成药批发商牌照，对负责人员（RP）的资格要求和西药批发商有何不同？独立链接
The qualification requirements for the Responsible Person (RP) under a wholesale licence for proprietary Chinese medicines are more specific to the Chinese medicine sector than those for Western medicine wholesalers. Although both require the RP to have knowledge and experience in supervising the handling of medicines, the RP for proprietary Chinese medicines needs a deeper understanding of Chinese medicines. According to the guidance of the Chinese Medicines Board, the RP of a wholesaler of proprietary Chinese medicines would generally need to meet one of the following qualifications: 1) be a registered or listed Chinese medicine practitioner; 2) have completed a recognised course in Chinese materia medica or a related field; or 3) have at least 5 years’ experience in wholesale of proprietary Chinese medicines or related business. By comparison, the background requirements for an RP for Western medicines tend to be more focused on Western pharmacy or related sciences. An RP for proprietary Chinese medicines needs a sound understanding of their sources and authenticity, storage conditions (such as protection from damp and mould), and Hong Kong’s specific labelling and registration requirements for proprietary Chinese medicines.
Q125 · 如果我只是想在香港的展会上短期推广或展示未经注册的药品，是否需要申请任何牌照？独立链接
This is a practical question, but the answer may be counter-intuitive: no. A pharmaceutical products wholesaler licence in Hong Kong is an “all-purpose” authorisation, and its application criteria and approval process do not fundamentally differ according to the types, risk levels or quantities of pharmaceutical products you intend to handle. Whether you plan to wholesale a range of high-risk prescription medicines or just one low-risk over-the-counter medicine, such as a vitamin supplement, you must meet all the requirements set out in the Code of Practice for Wholesale Dealers. This means that you still need to lease compliant premises, appoint a qualified Person-in-Charge, establish a complete Quality Management System (QMS) with SOPs, and pass a rigorous on-site inspection. The regulatory authorities’ rationale is that a licence confers a capability and qualification; once licensed, you could theoretically expand your product range, so you must meet the highest standards for managing all types of pharmaceutical products from the outset.
Q126 · 公司申请药品牌照，是否需要为其员工购买特定的职业责任保险？独立链接
Although the law does not require all types of pharmaceutical licence holders to purchase professional liability insurance, it is strongly recommended from a business risk management perspective. This is particularly true for medicine manufacturers and wholesalers, whose activities affect public health and safety and carry significant potential liability risks. Comprehensive Product Liability Insurance can provide financial protection against claims for personal injury or property damage caused to third parties by defective medicines. For pharmacies, purchasing Professional Indemnity Insurance for pharmacists is also standard practice, providing protection against claims arising from a pharmacist’s negligence or error when providing professional services such as dispensing or advice.
Q127 · 我是否可以聘请一名退休的卫生署药物办公室前雇员作为我公司的顾问或负责人员？独立链接
This is a very realistic and sobering question. If your licence application is formally refused by the regulatory authorities, most of the money already invested cannot be recovered. Specifically: 1. “Government application fees”: these are expressly non-refundable. 2. “Premises rent and renovation costs”: these arise under your commercial contracts with the landlord and renovation company and are unrelated to the outcome of the licence application; the money spent is largely a sunk cost. 3. “Equipment procurement costs”: purchased equipment may be resold at a discount, but a loss is inevitable. 4. “Professional consultancy fees”: these depend on the terms of your contract with the consultancy. Our contract at Rengangyongsheng (Hong Kong) Limited sets out the service fees for each stage, but fees for services already performed are generally not refundable if the application is unsuccessful.
Q128 · 申请药品牌照的公司，其名称有什么限制吗？是否可以包含“药剂”、“医疗”等字眼？独立链接
Yes, the use of company names is subject to certain restrictions. First, under the Companies Ordinance, a company name must not be the same as a company name already registered with the Companies Registry. Secondly, the use of certain words requires special approval. For example, if a company name includes “pharmacy”, “dispensary” or “pharmaceutical”, you must first obtain the consent of the Pharmacy and Poisons Board before applying to the Companies Registry to register the name. Similarly, words such as “hospital”, “medical” and “health” may require approval from the relevant departments. This is intended to prevent company names from misleading the public into believing that the company has qualifications or licences that it has not obtained.
Q129 · 作为一名注册药剂师，我是否可以在多家不同的药房同时担任“管售药剂师”？独立链接
No. Under the law, a registered pharmacist may personally manage and operate the business at the premises of only one Authorised Seller of Poisons (pharmacy) at any one time. This means that you cannot be named as the “pharmacist-in-charge” of two or more pharmacies simultaneously. The intent of the legislation is to ensure that the sale of medicines at each pharmacy is subject to the focused, continuous personal supervision of a pharmacist. If you wish to work at multiple pharmacies, you may work shifts at different pharmacies as an ordinary locum pharmacist, but in legal terms each pharmacy must have exactly one designated pharmacist-in-charge who bears ultimate responsibility for supervision.
Q130 · 申请药品牌照时，对公司股东的背景审查，会追溯到最终实益拥有人（UBO）吗？独立链接
Yes, the regulatory authority conducts a comprehensive and in-depth background review of applicant companies, going beyond the level of immediate shareholders. This is particularly relevant where the corporate structure is complex (for example, where several offshore companies hold shares through multiple tiers). The Drug Office, Department of Health, and the Pharmacy and Poisons Board (PPB) may require the applicant to disclose its full shareholding structure and identify the Ultimate Beneficial Owner (UBO). The regulatory authority will then carry out the same “fit and proper person” assessment of those UBOs, including reviewing their identity, financial position, business reputation and any criminal record. This is intended to prevent people from using complex corporate structures to conceal disqualifying status and circumvent regulation.
Q131 · 如果我的公司主要业务是医疗器械，但部分产品（如含药贴布）被界定为药品，我需要为整个公司申请药品牌照吗？独立链接
Yes, you need to apply for the appropriate pharmaceutical licence for the part of your business that handles products classified as medicines. Hong Kong regulates medicines and medical devices separately, through the Department of Health's Drug Office and Medical Device Division respectively. If one of your products—for example, an analgesic patch containing a western medicine ingredient—is classified as a “pharmaceutical product” based on its ingredients, mode of action or claimed therapeutic effects, any import, wholesale, retail or manufacturing activities involving it must be conducted under the relevant pharmaceutical licence. Your main business being medical devices does not exempt you from the licensing requirements for your medicine business. The company must establish a separate area that complies with Good Distribution Practice (GDP) for storing and handling these medicines, and appoint a qualified RP.
Q132 · 作为药品批发商的负责人员（RP），我是否需要为公司的商业决策（如定价、市场策略）承担法律责任？独立链接
No. The legal responsibilities of an RP focus mainly on technical operations relating to medicine quality, safety and compliance. Your core responsibility is to ensure that the company strictly complies with the Pharmacy and Poisons Ordinance and GDP at every stage, including procurement, storage, distribution and documentation. You are responsible for matters such as the legality of medicine sources, compliance of storage conditions, completeness of distribution records and effectiveness of the pharmacovigilance system. Commercial decisions, such as medicine pricing, marketing activities and sales targets, are usually handled by the company’s management or business department. Provided these commercial activities do not breach relevant laws such as those on medicine advertising or competition, the RP is not legally responsible for their commercial success or failure.
Q133 · 申请药品牌照的公司，是否必须加入某个商会或行业协会？独立链接
There is no legal requirement for a company applying for a pharmaceutical licence to join any chamber of commerce or industry association. Licence applications and approvals are based entirely on whether the applicant meets the statutory requirements set by the Drug Office, Department of Health and the Pharmacy and Poisons Board. However, joining one or more reputable industry associations, such as the Hong Kong Association of the Pharmaceutical Industry and the Hong Kong Chinese Medicine Merchants Association, is generally regarded as a positive step. It can help the company obtain the latest industry information, regulatory updates and market developments, as well as provide a platform for networking and exchanging views with industry peers. Membership of a recognised industry association can also, to some extent, demonstrate the company’s commitment to industry standards and business ethics to regulators and business partners.
Q134 · 如果我提名的负责人员（RP）或药剂师不会说粤语或中文，是否会影响申请？独立链接
To a large extent, this depends on the person’s specific position and responsibilities. For an RP at a pharmaceutical wholesaler or manufacturer, if their main duties are to oversee the internal Quality Management System and records, and they can communicate effectively with the Drug Office in writing and orally in English, language will not usually be a major barrier. Hong Kong is an international business centre, and English is one of its official languages; the regulator is fully able to communicate and conduct interviews in English. However, the situation is different for a registered pharmacist working in a pharmacy. Pharmacists need to communicate directly with local customers and provide advice on the use of medicines. If a pharmacist cannot communicate fluently in Cantonese with customers, particularly elderly people, this will seriously affect service quality and patient safety in the use of medicines. Cantonese is therefore almost essential for positions involving services to the public.
Q135 · When applying for a pharmaceutical licence, do I need to submit all employees' personal information for background checks?Direct link
No. Regulatory background checks are targeted and focus mainly on people with key responsibilities for the company’s operations and compliance. You do not need to submit details of every employee. Those generally required to provide detailed personal information and undergo a “fit and proper person” assessment include: 1) all company directors; 2) the company’s ultimate beneficial owner (UBO); 3) nominated key personnel, such as the RP for a wholesaler or manufacturer, an Authorised Person (AP) and the person in charge of quality control; and 4) the pharmacist-in-charge of a pharmacy. Personal details of non-key staff, such as warehouse operators, sales representatives and general clerical staff, do not need to be submitted to the regulatory authority at the licence application stage.
Q136 · 如果我的公司只是持有牌照，但暂时没有实际的药品进出口业务，我还需要维持一个合格的负责人员（RP）吗？独立链接
Yes, this must be maintained. A core and ongoing condition of a pharmaceutical wholesaler licence is that there must always be a Responsible Person (RP) accepted by the Pharmacy and Poisons Board (PPB). This requirement is unrelated to whether the company has any actual business volume. Even if your company has no imports or exports of medicines for a period, it remains a licensed entity under the law and must remain in a state of compliance readiness at all times. The presence of an RP is a key indicator of this readiness. The regulatory authority considers that, while the licence remains valid, the company may resume operations at any time and must therefore have a qualified professional to ensure that any potential activities are conducted within a compliant framework. The RP is also responsible for handling any legacy issues that may arise, such as enquiries or complaints concerning products sold in the past.
Q137 · 申请中成药制造商（GMP）牌照，对人员的卫生和健康有什么要求？独立链接
Proprietary Chinese medicine GMP (Good Manufacturing Practice) imposes strict hygiene and health requirements on all personnel involved in production, especially employees who come into direct contact with Chinese herbal medicines, semi-finished products or finished products. First, all relevant personnel must undergo a medical examination before taking up their duties to ensure that they do not have any infectious disease or skin condition that could contaminate medicines. Second, staff must receive systematic training in personal hygiene, including correct handwashing procedures and requirements for wearing clean work clothing. Before entering clean production areas, they must change into dedicated work clothing, footwear, headwear and masks. Eating, drinking, smoking and any other conduct that could contaminate medicines are strictly prohibited in production areas. If an employee develops any health condition that could affect medicine quality, such as a cold, diarrhoea or a skin wound, they must report it to their supervisor immediately and be temporarily reassigned from duties involving direct contact with products.
Q138 · 我公司的董事之一有被其他金融监管机构（如香港证监会SFC）处罚过的记录，这会影响药品牌照申请吗？独立链接
This could very likely have a negative impact on a pharmaceutical licence application. Although the SFC regulates the financial sector, a different field from pharmaceutical regulation, the Pharmacy and Poisons Board (PPB), when assessing whether an applicant is a “fit and proper person”, will consider their integrity and conduct across all business and professional activities. A public reprimand or penalty by the SFC or another major regulatory authority, particularly for reasons involving dishonesty, misconduct or inadequate internal controls, would be viewed by the PPB as a significant warning sign. The PPB may be concerned that a director who failed to discharge fiduciary duties in the financial sector might also be careless in the pharmaceutical sector, which concerns public health. You must therefore proactively disclose the matter fully in your application and provide a detailed explanation.
Q139 · 申请药品牌照，对人员培训的记录有什么具体要求？需要保存多久？独立链接
Training record management is an important part of a pharmaceutical quality management system, and regulators have clear requirements in this area. First, all staff involved in licensed activities must receive initial and ongoing training appropriate to their duties. Second, detailed records must be kept of every training activity. Training records should generally include the date, topic, outline of content, trainer’s name and qualifications, and the signatures of participating staff. For key training in Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP), it is also advisable to keep records of post-training assessments or evaluations. All such training records must be properly retained. As a general recommendation, retain records for at least 5 years or, where specific product expiry requirements apply, for the longer period.
Q140 · 如果我只是个人（非公司），是否可以申请“列载毒药销售商”牌照在自己的小店里卖药？独立链接
Yes. Unlike most other pharmaceutical licences, for which the applicant entity must be a limited company, an application for a Listed Seller of Poisons (LSP) licence (commonly known as a “medicine shop licence”) offers more flexibility. You may apply as an individual (sole proprietor), partnership or limited company. If you apply as an individual, you will be the licensee and bear full legal responsibility for the licensed activities of the shop. You must submit your personal identity documents with the application and sign all application forms in your own name. Regardless of whether the applicant is an individual or a company, all other licensing requirements must still be met, including having suitable business premises, providing appropriate staff training and complying with all relevant codes of practice.