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
找到 38 条结果，第 2／2 页。每页显示 20 条；无需启用 JavaScript。
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.
Q164 · 如果我的业务同时涉及西药和中成药，是否可以在同一个仓库内储存？独立链接
It is permissible to store Western medicines and proprietary Chinese medicines in the same warehouse, but strict physical segregation and operational separation are required to prevent cross-contamination and mix-ups. First, the warehouse must have clearly defined, physically separated areas for Western medicines and proprietary Chinese medicines. Ideally, use separate rooms or separate them with solid walls. If this is not feasible, at least store them in different areas of the warehouse using a racking system and provide very clear labels. The handling processes for the two product categories (receipt, inspection, put-away, picking and checking) should be separated as far as possible, and they should not be handled at the same workstation or at the same time. In particular, some Chinese herbal medicines may have a strong odour or generate dust, so they must be strictly segregated from Western medicines to prevent odour or physical cross-contamination.
Q211 · 申请中药材零售商牌照和申请西药批发商牌照在流程上有什么主要区别？独立链接
Although both Chinese herbal medicine retail licences and Wholesale Dealer Licences are administered by the Department of Health, they fall under different departments, with significantly different approval processes and areas of focus. First, the regulatory authorities differ: Chinese medicine licences are handled by the Chinese Medicine Regulatory Office (CMRO), while Western medicine licences are handled by the Drug Office (DPO). Second, personnel requirements differ: Chinese medicine retailers must employ a sufficient number of qualified Chinese medicine practitioners according to the shop’s size, such as Chinese herbal medicine dispensers or Chinese medicine dispensers, whereas Western medicine wholesalers must appoint an RP. Third, premises requirements differ: Chinese herbal medicine retail shops need designated areas for displaying, storing and dispensing Chinese herbal medicines, and must comply with the storage guidance in the Hong Kong Chinese Materia Medica Standards; Western medicine wholesale warehouses place greater emphasis on temperature and humidity control, security and logistics management. Finally, the governing legislation differs: the former is mainly governed by the Chinese Medicine Ordinance (Cap. 549), while the latter is governed by the Pharmacy and Poisons Ordinance (Cap. 138).
Q213 · 从递交申请到最终获批，申请一个西药批发商牌照通常需要多长时间？独立链接
This is a question of great concern to all applicants. According to the service pledge published by the Drug Office, Department of Health, it aims to complete the processing of wholesale dealer licence applications within 5 months of receiving all the required documents and fees. However, this is only an ideal timeframe. In our practical experience, the duration of the entire process depends on several factors. If your application documents are impeccable, the premises pass inspection first time, and the Person-in-Charge performs well, approval within 5 to 6 months is entirely possible. However, if there are any setbacks along the way—for example, further documents are required, the premises need rectification, the Person-in-Charge changes, or a committee interview is needed—the process may take 9 months or even more than 12 months. A more realistic expectation is therefore 6 to 9 months.
Q254 · 我计划申请中药材零售商牌照，其政府收费与西药牌照有何不同？独立链接
Government fees for an application to retail Chinese herbal medicines differ from those for Western medicine licences. Applications are handled by the Chinese Medicines Board under the Chinese Medicine Council of Hong Kong (CMCHK). Specifically, the application fee for a Chinese herbal medicine retailer licence is HK$770, and the issue fee upon successful approval is HK$1,160. By comparison, the application and issue fees for a Wholesale Dealer Licence are HK$1,030 and HK$2,150 respectively. Although government fees alone make Chinese medicine licences appear slightly less expensive, this does not mean the overall start-up costs are lower; other investments remain the main expenses.
Q255 · 牌照续期是否需要付费？西药和中药牌照的续期费用分别是多少？独立链接
Yes, all pharmaceutical and Chinese medicine licences are non-permanent and must be renewed periodically, with the applicable fees paid. For western medicine licences, such as a pharmaceutical product wholesaler licence, the annual renewal fee is 2,150 units, the same as the initial issue fee. An annual fee must also be paid each year for an Authorised Seller of Poisons (ASP) (pharmacy) licence. For Chinese medicine licences, such as a retail licence for Chinese herbal medicines, the annual renewal fee is 1,160 units. These renewal fees are necessary ongoing expenses for maintaining your lawful right to operate and must be paid on time.
Q261 · 总体来看，从零开始设立一家符合标准的西药批发商，我应该准备多少启动资金？独立链接
Establishing a compliant wholesaler of Western medicines is a substantial capital investment. In our experience, a comprehensive start-up budget should cover the following core areas. First, premises costs, including at least 3 months’ rental deposit and rent in advance, as well as basic fitting-out costs. Second, compliance system establishment, including a complete set of pharmaceutical manufacturing quality management (QMS) documents, temperature and humidity monitoring and recording equipment, and installation of security systems. Third, professional service fees payable to consultancy firms such as ours. Finally, and most importantly, working capital: you need to reserve at least 6–9 months of operating funds to pay staff salaries, rent, utilities and purchases of the initial stock of medicines. Overall, we recommend preparing at least HKD 1,500,000 to HKD 3,000,000 in start-up capital for a small or medium-sized wholesaler of Western medicines.
Q288 · 我计划同时经营西药批发和中成药批发，是否需要为这两个业务设立独立的财务账目？独立链接
Although the law does not require separate legal entities or bank accounts for different business lines within the same company, from a management and compliance perspective we strongly recommend setting up separate “cost centres” or “profit centres” in your accounting system for wholesale of western medicines and wholesale of proprietary Chinese medicines. This means you should be able to track and distinguish clearly the sales revenue, procurement costs, inventory value and related operating expenses for each. This gives you a more detailed management perspective and allows you to assess the profitability of each business area accurately.
Q370 · 作为持牌中药材批发商，我们是否需要遵守“良好分销规范”（GDP）？独立链接
Although the “Good Distribution Practice” (GDP) currently required by Hong Kong legislation primarily concerns the Code of Practice for Pharmaceutical Wholesalers for western medicine wholesalers, its core principles are equally important in protecting the quality of Chinese herbal medicines during storage and distribution, and are regarded by regulators as best practice. Chinese herbal medicines are also exposed to risks from changes in temperature and humidity, insect infestation, mould and cross-contamination. Accordingly, as a responsible Chinese herbal medicine wholesaler, you should voluntarily adopt and implement core GDP principles. These include establishing a quality management system; ensuring staff are appropriately qualified and trained; maintaining compliant storage facilities, such as adequate ventilation and protection against damp and pests; applying effective inventory management, such as first in, first out; keeping complete purchase and sales records for traceability; and establishing procedures for handling complaints and returns.
Q401 · 我的西药批发商牌照即将到期，具体的续期流程是怎样的？独立链接
An application to renew a Wholesale Dealer Licence should be submitted within the 3 months before the licence expires, but no later than the expiry date. You must submit the designated renewal application form to the Drug Office, Department of Health, together with relevant documents, such as a copy of the company’s Business Registration Certificate, the company’s annual return and payment of the renewal fee. The Drug Office will review your application and may arrange an on-site inspection to ensure that your business operations, premises and facilities, and Quality Management System still meet licensing requirements. The renewal process usually takes several weeks. We recommend preparing early to avoid disruption to your business if the licence expires.
Q409 · 在什么情况下，违规经营药品会从行政处罚上升到刑事检控？独立链接
Whether a breach in the course of dealing in medicines will lead to criminal prosecution depends mainly on its nature and seriousness. Serious offences involving public health and safety, or conduct with an obvious fraudulent intent, are highly likely to result in criminal prosecution. Examples include operating any type of medicine business without a licence; selling or possessing unregistered pharmaceutical products (“counterfeit medicines”); selling proprietary Chinese medicines containing undeclared Western medicine ingredients; illegally selling antibiotics or dangerous drugs; and adulterating medicines with harmful substances. Such cases are usually investigated jointly by the Department of Health and the Commercial Crime Bureau of the Hong Kong Police Force, with the Department of Justice deciding whether to prosecute.
Q411 · 申请牌照续期的费用是多少？如果迟交会有罚款吗？独立链接
Renewal fees differ between licence types. For example, the current renewal and issue fee for a Western medicine Wholesale Dealer Licence is HK$2,150, while the renewal fee for a Listed Seller of Poisons is lower. The key point is that the legislation does not provide for “late filing fines”. If you miss the deadline for submitting a renewal application before the licence expires, the consequence is not a fine; the licence simply becomes invalid. This means you must stop business immediately and submit a completely new licence application. The overall process and cost are far greater than those of timely renewal. Renewal must therefore be treated as a top priority.
Q422 · 我持有西药批发商牌照，可以偶尔向最终消费者少量销售药品吗？独立链接
Absolutely not. The type of licence strictly defines the scope of your business. A Wholesale Dealer Licence authorises you to supply medicines to specified parties, such as other licensed wholesalers, licensed manufacturers, registered pharmacies, hospitals and registered doctors. It is, by nature, a B2B (business-to-business) activity. You must not sell medicines directly to end consumers, regardless of the quantity. Direct sales of regulated medicines to the public are the exclusive right of an Authorised Seller of Poisons (ASP) (pharmacy) or a Listed Seller of Poisons (LSP).
Q426 · 作为持牌西药批发商，我需要保存哪些交易记录？需要保存多久？独立链接
Under the Good Distribution Practice (GDP) requirements for wholesale dealers in medicines, you must keep detailed records of the receipt and supply of all medicines to ensure complete traceability. Records should include, at a minimum: the name of the medicine, dosage form, strength, batch number, expiry date, transaction date, name and address of the supplier or recipient, and quantity involved. All records must be properly kept and made available for inspection by Department of Health inspectors at any time. The law requires these records to be retained for at least two years from the transaction date.
Q437 · 我是否可以将药品存放在持牌地址以外的地方，例如迷你仓？独立链接
Absolutely not. Under Hong Kong law, all regulated medicines, whether Western medicines or proprietary Chinese medicines, must be stored at licensed premises specified on the licence and approved by the regulatory authority. The facilities at these premises, including temperature and humidity controls, security systems and fire prevention measures, are subject to rigorous scrutiny to ensure the quality and safety of the medicines. Unapproved external storage locations, such as offices, homes or mini-storage units, do not meet statutory storage requirements. Storing medicines at these locations is a serious breach.
Q439 · 针对中成药的监管，和西药相比，在违规处罚方面有什么主要不同？独立链接
Although proprietary Chinese medicines and Western medicines are regulated by different bodies (the Chinese Medicine Council of Hong Kong and the Pharmacy and Poisons Board), their regulatory philosophies and penalty principles are similar, with the protection of public health as the primary objective. The main differences lie in the specific legal bases and certain types of non-compliance unique to each. For example, regulation of proprietary Chinese medicines focuses particularly on quality standards for “heavy metals and toxic elements”, “pesticide residues” and “microbial limits”. Breaches of these standards are serious forms of non-compliance specific to proprietary Chinese medicines. Proprietary Chinese medicines are also subject to the issue of “unregistered proprietary Chinese medicines”, similar to “unregistered pharmaceutical products” in the case of Western medicines. In general, penalties for serious offences such as unlicensed operations and the sale of counterfeit or substandard products are severe for both, including substantial fines and imprisonment.
Q441 · 我的西药批发商牌照续期申请被拒绝了，主要可能是什么原因？独立链接
Refusal of a renewal application is uncommon but has serious consequences, and usually stems from fundamental compliance issues. The most common reasons include serious breaches during the previous licence period, such as repeated warnings or disciplinary action; major deficiencies identified during the renewal inspection that were not corrected promptly, particularly in the Quality Management System (QMS), medicine traceability or storage conditions; the company or one of its key personnel being convicted of a criminal offence, leading the regulator to consider it no longer a ‘fit and proper’ licence holder; or failure to provide key documents required for the renewal review, such as a valid Business Registration Certificate or SOP documents meeting GDP requirements.
Q443 · 我是否可以在同一个持牌处所内，同时经营西药批发和中成药批发业务？独立链接
Yes, but you must apply for and hold two different licences for the premises: a Wholesale Dealer Licence issued by the Department of Health and a wholesaler’s licence for proprietary Chinese medicines issued by the Chinese Medicine Council of Hong Kong. In addition, you must establish clearly segregated physical areas within the premises for storing Western medicines and proprietary Chinese medicines separately, to prevent cross-contamination and confusion. Two separate Quality Management Systems and record-keeping systems are also essential, each meeting the GDP requirements for Western medicines and the relevant requirements for proprietary Chinese medicines. During inspections, the regulatory authorities will independently inspect each area and system.